Podcasts about GXP

We welcome Karla Childers to AI Uncovered. Karla is a long-standing leader in bioethics and data transparency in the pharmaceutical industry. As part of the Office of the Chief Medical Officer at Johnson & Johnson, she brings deep expertise in navigating the ethical implications of emerging technologies, especially artificial intelligence, in medicine and drug development.In this episode, Tim and Karla explore the intersection of AI, bioethics and patient-centered development. They discuss how existing ethical frameworks are being challenged by the rise of generative AI and why maintaining human oversight is critical—especially in high-context areas like clinical trial design, consent and medical communications. Karla also shares her views on the future of data privacy, the complexity of patient agency and how to avoid losing trust in the race for efficiency.Karla is a strong advocate for using innovation responsibly. From her work with internal bioethics committees to her perspective on evolving regulatory expectations, she offers bold insights into how the industry can modernize without compromising ethics or equity.Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

Wir denken selten darüber nach, aber damit die Arzneimittel, die teilweise unser Leben retten, genauso sicher und verlässlich zur Verfügung stehen wie wir es gewohnt sind, muss jede Menge Daten erfasst werden. Aber warum ist das so wichtig? Und was gibt es hier zu beachten? Darüber spricht Christian Krug, der Host des Podcasts „Unf*ck Your Data“ mit Christof Layher Director Validation digital Systems bei Biontech und Host des Chaoshacker Podcast.Nun die Antwort kann ganz einfach beginnen: Weil Menschenleben davon abhängen! Deshalb muss bei allen Prozessen von Erforschung, Erprobung über Herstellung bis zur Verteilung von Medikamenten, vieles genau dokumentiert werden.Ohne Standard würde das sehr schnell sehr chaotisch werden. Genau diese Standards kürzt man gerne als GXP. Das G steht für Good, das P für Practice. Dazwischen ist jede Menge Platz für C (Clinic), L(Laboratory), M(Manufacturing) oder D(Distribution).Das heißt für jede Anwendung gilt es den richtigen Standard zu wählen. Die Königsdisziplin ist es dann den jeweils nächst höheren mitzudenken.Als wäre das jetzt nicht schon schwer genug, sind diese Standards nicht international einheitlich und lassen manchmal auch ein bisschen Luft nach oben.Gerade bei den so genannten kritischen Daten.Denn diese sind es, die unbedingt erfasst, dokumentiert und archiviert werden müssen. Und natürlich mit den nächsten Standard ALCOA+. Was der alles beinhaltet, erklärt Christof dann auch im Detail.Auch wenn allen klar sein sollte, dass es bei Pharmazie um Menschenleben geht, so haben doch viele der Regeln eines gemeinsam: Sie wurden festgelegt nachdem mal jemand ordentlich daneben gelangt hat. Ein trauriges Beispiel ist der Contergan-Skandal. Bei dem ungenügende Testung zu erheblichen Beeinträchtigungen und Fehlbildung bei ungeborenen Kindern führte.Generell wird die Bedeutung von Daten im Arzneimittelbereich nochmal deutlich wenn wir sehen, dass 80% aller Warnbriefe der US Aufsichtsbehörde (FDA) auf mangelnden Umgang mit Daten zurückzuführen sind.Das heißt die Anforderungen sind aus guten Grund so hoch. Und sie steigen ständig weiter, denn in GXP gilt oft das Gegenteil der DSGVO – Mehr Daten sammeln ist besser.Klingt doch logisch, oder?▬▬▬▬▬▬ Profile: ▬▬▬▬Zum LinkedIn-Profil von Christof: https://www.linkedin.com/in/christoflayher/Zum Chaoshacker Podcast: https://open.spotify.com/show/6IyYylGFei1TiPNnJtnXJw?si=9195387909a44861Zum LinkedIn-Profil von Christian: https://www.linkedin.com/in/christian-krug/Christians Wonderlink: https://wonderl.ink/@christiankrugUnf*ck Your Data auf Linkedin: https://www.linkedin.com/company/unfck-your-data▬▬▬▬▬▬ Buchempfehlung: ▬▬▬▬Buchempfehlung von Christof: Der Schwarze Schwan - Nassim Nicholas TalebAlle Empfehlungen in Melenas Bücherladen: https://gunzenhausen.buchhandlung.de/unfuckyourdata▬▬▬▬▬▬ Hier findest Du Unf*ck Your Data: ▬▬▬▬Zum Podcast auf Spotify:

We're excited to welcome Oeystein Kjoersvik to AI Uncovered. Oeystein leads the Generative AI program within the Quality Assurance team at Merck, where he focuses on developing AI tools and applying a quality-first approach to ensure safe, effective use of AI in GxP-regulated environments.In this episode, Tim and Oeystein delve into the challenges of adopting AI in regulated settings, the complexity of validating GenAI tools, and the transition from traditional processes to AI-augmented systems. They also explore Oeystein's work with the IMPALA Consortium and the importance of cross-industry collaboration to identify and scale high-value use cases for Generative AI.Before his current role, Oeystein served as a Product Owner in Analytics at Merck IT, building analytics platforms and integrating data science across systems. He also contributed as a Machine Learning Subject Matter Expert to TransCelerate's Intelligent Automation Group, advancing AI applications in pharmacovigilance.Oeystein brings a rare blend of technical expertise and regulatory insight. He's passionate about helping teams adopt AI responsibly and transparently—ensuring innovation aligns with quality across the pharmaceutical landscape.Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

This week's guest is Daniele Iacovelli (https://www.linkedin.com/in/daniele-iacovelli-8684a9b2/), VP, Global Head of Digital, Analytics (AI) & Operational Excellence at Roche. Although regulated industries like pharmaceutical manufacturing can be slow to digitally transform their manufacturing operations, Daniele lays out how changing trends in the industry have led Roche to architect a new digital production system, with a focus on a composable, future-proof architecture. He also lays out how rapid solution development enabled by new software platforms and a citizen developer approach is enabling people across the company to solve their own problems, while also laying the groundwork for rethinking the traditional software validation approach that dominates regulated industries. Plus, what the role of GenAI should be in a GxP environment, and more. Augmented Ops is a podcast for industrial leaders, citizen developers, shop floor operators, and anyone else that cares about what the future of frontline operations will look like across industries. This show is presented by Tulip (https://tulip.co/), the Frontline Operations Platform. You can find more from us at Tulip.co/podcast (https://tulip.co/podcast) or by following the show on LinkedIn (https://www.linkedin.com/company/augmentedpod/). Special Guest: Daniele Iacovelli.

In today's episode I was joined by James Myers, VP Quality at Spyre Therapeutics.I wanted to speak with James about his journey, starting in GCP focussed roles and learn how he transitioned into all encompassing GxP position. As a result James has gained exposure across GCP and GMP and developed himself as a true GxP quality professional. We discuss the following:Transitioning from GCP to GMP.Industry Trends.Gaining GMP Experience.Advancing to VP from director.Building a Team and Pilot Plant.Collaboration with Stakeholders.Gaining Organizational Buy-In.Importance of Listening.Strategic Thinking.'Jim' is a great leader and most importantly a genuinely nice human being that has impacted people throughout his career in pharma and biotech. He is a credit to the industry and I'm sure his journey will inspire others to follow in his footsteps!Thank you Jim for sharing your journey with us!Hope everyone enjoys the show.

In this episode, Yan Kugel is joined by Will Moss founder and CEO of Seal, about the critical need for automation in GXP processes. Will shares his expertise on balancing automation with human oversight, addressing data privacy concerns, and the future of quality management in the pharmaceutical sector.

Join us for an exciting dive into the latest innovations from the Listrak Growth Xcelerator Platform (GXP). Discover how GXP is revolutionizing customer engagement and revenue growth with cutting-edge strategies and tactics. From a 5-7X increase in triggered revenue to over 100% subscriber growth, see how our innovative pop-ups, personalized website journeys, and AI-driven shopping assistants are making a significant impact. Tune in to learn about the groundbreaking work happening in the labs and how these advancements can turbocharge your business.

Yan Kugel⁠ is joined by Jakob Konradsen, the Co-Founder & Head of Quality at Eupry and here he discusses the importance of moving away from paper or PDF calibration certificates and manual work in the GXP industry. They explore the idea of using machine learning algorithms for auditing and the need for a business continuity plan for temperature control. The speaker emphasizes the value of being prepared for potential issues and encourages professionals to focus on improving emergency response plans. The episode ends with a recommendation to connect with the speaker on LinkedIn for further discussions on temperature control.

In today's episode, we have a special guest, Harsh Thakkar, who has made a successful journey into consulting within the pharmaceutical industry. Harsh is a seasoned professional with extensive experience in advising on GXP practices and regulatory compliance. His career in consulting in the life science field is filled with insights, challenges, and triumphs that have shaped his career and made him a respected figure in the industry. The podcast is brought to you by ⁠Qualistery⁠, a leading provider of webinars, training, and consulting for the pharma industry. For business inquiries, get in touch at info@qualistery.com.

Ever wondered why the life sciences industry is stuck in redundant vendor qualification processes? Picture an organization where quality is designed rather than inspected. Yes, it's possible and we're about to paint that picture for you in this stimulating conversation with our guests, Dele Babalola and Rani Naik. They've got their fingers on the pulse of the GxP space and are ready to share their insights on the pressing need to evolve from redundant processes. Pay attention as Rani unfolds her unique vision for an agile, phase-appropriate quality organization. Imagine a world where vendor qualification is not a daunting task but a streamlined process. We got you thinking, right? Dele and Rani join us to unravel this concept further. It's all about being proactive, focusing on effective oversight, and perhaps venturing into the world of pre-approved vendors. From discussing the role of certification bodies to emphasizing the significance of a proactive approach, we've got this topic well covered. Enter the world of vendor management where challenges are like a complex puzzle waiting to be solved. This is where Dele and Rani's expertise shines as they shed light on transparency, collaboration, and the risk-based approach. Here's a plus - they also detail the potential value of remote audits and the importance of having an internal individual who can ensure clear process flow. As we wrap up, we can't help but yearn for a more innovative industry that's ready to take leaps. You won't want to miss this candid conversation.________Reach out to Sam Parnell and Ivanna RosendalJoin the conversation on our LinkedIn page

In der Mittagsfolge sprechen wir heute mit Dr. David Schneider, CEO und Founder von Qualifyze, über die erfolgreich abgeschlossene Finanzierungsrunde in Höhe von 12 Millionen US-Dollar.Qualifyze ist ein Anbieter von strukturierten und analysierbaren GxP-Audit-Daten, die aus Vor-Ort-Inspektionen in der pharmazeutischen Lieferkette resultieren. Durch die Servicepläne profitieren Pharmaunternehmen vom Zugang zum nach eigenen Angaben größten Bestand an Auditdaten, indem sie Auditguthaben erwerben, die flexibel für Auditberichte, Datenanalysedienste und Softwarelösungen eingelöst werden können. Dabei müssen sie sich nicht auf einen bestimmten Auditstandard oder eine bestimmte Lieferantengeografie festlegen. Das Startup erfasst und konvertiert außerdem proprietäre Audit-Rohdaten, um einzigartige Einblicke in das Niveau der Lieferantenkonformität in der gesamten Lieferkette zu gewinnen. Über die Cloud-basierte Plattform können die Kundenunternehmen jederzeit auf die Compliance-Informationen der Lieferanten zugreifen und diese standortübergreifend auswerten, was einen neuen Weg zur Optimierung von Prozessen zur Risikominderung bei Lieferanten auf rationale und kosteneffiziente Weise darstellt. Qualifyze wurde im Jahr 2019 von Dr. David Schneider und Florian Hildebrand in Frankfurt am Main gegründet. Seit der Einführung der Lösung hat das Startup bereits Tausende von Lieferanten auditiert und mehr als 1.000 Pharmahersteller dabei unterstützt, die Einhaltung der Lieferkette zu verbessern und die Kosten für die Lieferantenqualifizierung zu senken. Das Netzwerk besteht mittlerweile aus über 200 lokalen auditierenden Expertinnen und Experten. Im Jahr 2023 wird das Unternehmen ein Umsatzwachstum von voraussichtlich mehr als 10 Millionen US-Dollar erreichen, womit Qualifyze seinen Wachstumskurs von 100 % gegenüber dem Vorjahr fortsetzt.Nun hat das Frankfurter Startup in einer Finanzierungsrunde 12 Millionen US-Dollar eingesammelt. Die bestehenden Investoren HV Capital und Rheingau Founders sowie die neuen Investoren HarbourVest Partners und H14 haben sich an der Runde beteiligt. Das zusätzliche Kapital wird auch genutzt, um die Expansion innerhalb bestehender und in neue geografische Märkte fortzusetzen, um als Zielvision die Referenzplattform für Supply-Chain-Compliance-Daten in der Pharmaindustrie zu werden. Ca. 80 % der Kundenunternehmen sind bereits außerhalb Deutschlands und ca. 20 % außerhalb Europas angesiedelt, wodurch Qualifyze bereits Erfolge auf dem internationalen Markt vorweisen kann. 

What exactly is 'phase-appropriate' quality?In episode 4 of Let's Talk Quality, I was joined by Amnon Eylath to discuss the origins of the well known term, 'phase-appropriate' quality. Amnon and I discuss the following:What exactly is 'phase-appropriate' quality?The history of GxP and how the term originatedHow the FDA guidance has evolved, and how it startedAmon's role in liaising with the FDA to develop a 'graded approach' to qualityHow this approach evolved into the term 'phase-appropriate' What factors to consider when implementing quality that is 'phase-appropriate'Real-life examples where this impacted the commercialisation of therapiesManaging upwards with C-suite to promote quality within an organizationThe importance of understanding the science and technologyWhat inspires Amnon to progress and contribute to society This is a fascinating discussion about such a widely used phrase in quality assurance and the wider pharma and biotech industry. Amnon's knowledge on this subject matter dates back to before the term was coined and it's fascinating to speak to someone who played a significant role in identifying the importance of implementing quality at the right time and to the right extent. Hope you enjoy the show!

Artificial Intelligence is the actual hot topic that everyone is talking about. A lot of countries are starting to regulate this technology. But what are we talking about. This episode will help you understand AI and also understand what the risks to it are. This is really an interesting topic, but a lot of people are really afraid when we talk about AI. We will try to give you some tips to clarify the situation.  For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies who use Artificial Intelligence for their software.  Who is Christophe Girardey?  Christophe Girardey is Managing Director at Wega, a life science consulting company specializing in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. Wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. Wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development.  Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/ Wega Website : https://www.wega-it.com/  Medical Device Compliance: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance  Data Sciences: https://www.wega-it.com/clinical-development-it#data-science  Wega Breakfast: Artificial Intelligence in GxP environments: https://www.youtube.com/watch?v=dCDwEkXd9jU&t=11s  Nature Article (co-authored):  https://www.nature.com/articles/s41582-020-00448-7FDA list of Software with AI: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices? Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

Eine neue Folge der Rubrik „Junge Startups” ist da!

Summary: A lot of statistical work within pharmaceutical companies is repetitive and this costs money and resources, especially if it's done within GxP environments where there is often a need for double programming, extensive data quality control and meticulous follow-up of procedures. The podcast explores requirements and ways  to  develop fully automated solutions and processes to address this repetition and improve overall business efficiency. Speaker: Davor Josipovic is senior manager statistics and data science at PharmaLex, focusing on developing innovative solutions for questions the pharmaceutical industry faces, using applied mathematics, probabilistic modelling and machine learning. Links: General page: https://www.pharmalex.com/pharmalex-departments/data-science-in-pharmaceutical-industry/ Custom solutions: https://www.pharmalex.com/software-login/

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Henal Shah, Life Sciences Lab Practice Head at Cognizant. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Henal, with a focus on: Decoding digital transformation and what it means for pharmaceutical companies across the life sciences supply chain Delivering fascinating insights into what a state-of-the-art smart factory and lab of the future look like The complexity of collating siloed data and connecting, orchestrating and presenting it into meaningful information that aids improved decision-making The four key trends Henal is seeing driving the pharmaceutical laboratories sector right now Henal is Head of the European Lab Centre of Excellence (CoE) Practice within the Life Sciences Manufacturing Group at Cognizant. Holding a management degree in marketing, she has more than 20 years of experience in multiple sectors, primarily in life sciences pharma. Henal has led the Life Sciences Quality Engineering and Assurance practice for more than a decade within Cognizant across the UK and Ireland. Her experience spans through lab systems implementation, lab digital transformation, lab automation, mergers and acquisitions, GxP validation, and testing and compliance across the life sciences value chain including discovery, research and development, manufacturing pharmacovigilance, and sales & marketing to product launch. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing. An international content, design and digital agency that helps companies in life sciences, get noticed.

One of the most common concerns in GxP quality is maintaining the temperature of laboratory and manufacturing storage environments. Temperature Mapping, also known as thermal mapping, is an activity performed on temperature-controlled chambers often used to track temperature changes within the storage space over a long period. This podcast episode focuses on the importance of temperature mapping studies and why they are so critical for pharmaceutical compliance. Our guest speaker is Nathan Roman, one of the top experts in Temperature control mapping who help people in the Health & Life Science industry learn how to implement and carry out temperature mapping studies and equipment qualifications (IQ, OQ, PQ). Listing to the podcast, or watching the video, among others, you will learn about: What are temperature mapping studies, and why are they so critical for pharmaceutical compliance? Where is thermal mapping required, and why? What is the process for a temperature mapping study? What is the most challenging part of your job? What do most people do wrong with thermal mapping, and what would be your suggestion to improve? What resources can help pharma professionals stay updated with the latest regulations and trends? So tune in to learn all there is to know about thermal mapping and its impact on pharmaceutical compliance! ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at: https://podcast.qualistery.com/what-is-thermal-mapping-and-why-its-so-important-nathan-roman/ ------------------------------------------------------------------------------------------------------ This episode is Sponsored by Eupry, a provider of state-of-the-art environmental monitoring systems. Eupry supports the further development of a host of industries, including Laboratory, Pharmacy, Healthcare, Pharma, Food, and more, by providing efficient solutions to monitor temperature-sensitive assets. Join us on our webinars and visit our website for more GMP insights, tips, and resources. Don't miss out - follow Qualistery today! #Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

Rob Lutskus is a subject matter expert on GxP informatics solutions with over 20 years' experience in the bio-pharmaceutical industry. Currently Director and Commercial Operations for Lonza Bioscience Informatics, Rob is responsible for leading all technical sales support, customer service, development, testing, validation and professional delivery activities for Lonza's Informatics software portfolio. He also develops the product strategy and roadmap for software releases. The portfolio he manages, started with environmental monitoring software, MODA-EM™ and has expanded to laboratory software, WinKQCL™ and manufacturing and electronic log software, MODA-ES™ Rob is an active member in a variety of industry organizations, including the Parenteral Drug Association and ISPE. He is also a contributing author to Environmental Monitoring: A Comprehensive Handbook, Volume 3. #manufacturingit #manufacturingtechnology #MES #industry40 #ManufacturingOperationsManagement #ManufacturingIntelligenceSystems #ManufacturingExecutionSystems #ProcessAutomationSystems #IndustrialInternetofThings #IIoT #ComputerSystemValidation #ProcessControlSystems #DataHistorianSystems #AdvancedAnalytics #SCADA #Syncade #DeltaV #Pasx #RockwellFactoryTalk #rockwell #PlantPAx #AllenBradley #RSLogix #SiemensSimatic #siemens #SimaticBatch #PCS7 #Step7 #WincCC #Wonderware #GE #SAP #PomsNet #Apriso #Werum #OSI #LIMS #800xA #SattLine

Today we're talking to Michael Tarselli Chief Scientific & Knowledge Officer of TetraScience. Mike was the Scientific Director for SLAS, a global professional society dedicated to lab automation and an Associate Director at Novartis building an external scientific collaboration platform. You can read the full bio in the show notes. TetraScience is bringing the future of scientific data to today and has built the largest integration network of lab instruments, informatics applications, CRO/CDMOs, analytics, and data science partners, creating seamless interoperability and an innovation feedback loop that will drive the future of life sciences and the delivery of life-saving therapeutics. More about Mike TarselliChief Scientific & Knowledge Officer of TetraScience, Mike Tarselli, explores the Tetra Scientific Data Cloud™ through knowledge capture, GxP compliance, and use case research. Previously, Mike was the Scientific Director for SLAS, a global professional society dedicated to lab automation and an Associate Director at Novartis building an external scientific collaboration platform. Mike received his Ph.D. from UNC Chapel Hill, completed postdoctoral work at Scripps Research, and his MBA through Quantic School of Business & Technology.Show Notes:Tetra Science Website - https://tetrascience.com/Demo of TetaScience - https://www.tetrascience.com/demoBenchmark Data from TetraScience  -https://go.tetrascience.com/researchreport_Scientific-Data-Imperative-Establishing-a-New-Benchmark-After-Two-Decades.htmlGXP Solution Brief - https://www.tetrascience.com/solution-brief/gxp-with-tetra-scientific-data-cloudQualio website:https://www.qualio.com/ Previous episodes:https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show:https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

An in depth conversation with one of the more well known G8 owners. Chris's car is known for his teal turbo's and cutting holes in a GXP bumper! 

Well, we've made it to 2023. Somehow. In commemoration of this achievement, we're getting back to what we do sort-of best: small town college anime club-styled radio. Admit it, you've missed us, too. And to get back into the swing of things, we have something everyone enjoys: LISTS. And a good number of them, recounting the things that came out in the year prior, from the good and bad to the curiously headscratching. As per usual when we return from an extended break, please pardon our dust - it always takes us a bit of time to find our flow again. intro - the grand return and plans going forward 16:45 - main stories 1:06:06 - anime announcements and updates 1:36:56 - LIST-MANIA 2022 2:15:39 - upcoming home video releases 16:45 - RIP Yuji Nunokawa, founder of Pierrot 19:06 - a big One Piece dub update 25:07 - happy retirement, Ash! (Pokémon anime update) 33:13 - Kodansha brokers a larger deal with Disney 42:50 - Pantheon gets axed by AMC 49:55 - another late LOLsuit update 56:52 - Monster arrives on Netflix… with a catch 1:00:04 - Kessoku Band tops the IRL charts 1:01:34 - Akiba Maid War dub starts this weekend 1:06:06 - Jump Festa announcements 1:22:43 - Dragon Quest NOW on Hoopla (for free) 1:23:56 - Zom 100 anime announced for summer 1:29:41 - Fate/strange fake postponsed to summer 1:32:04 - more Bastard!! coming to Netflix later in 2023 1:34:07 - why is there more GXP happening? 1:36:56 - LIST-MANIA 2022: favorite shows in Japan 1:42:41 - Oricon 2022 light novel sales 1:45:22 - Oricon 2022 manga sales 1:54:29 - theatrical films in Japan 1:58:32 - the ANN Mega-Poll results 2:15:39 - misc. home video slates (GKIDS, Media Blasters, Viz) 2:20:05 - Crunchyroll March slate 2:25:03 - Sentai March/April slates 2:30:02 - Discotek February 28th slate Apple Podcasts – https://itunes.apple.com/us/podcast/podcastona/id1348141210?mt=2 Google Play – https://podcasts.google.com/feed/aHR0cDovL3d3dy5wb2RjYXN0b25hLnN1cnJlYWxyZXNvbHV0aW9uLmNvbS9mZWVkL3BvZGNhc3Q Spotify – https://open.spotify.com/show/2JZLO3LfoeHepomejTw4TP iHeartRadio – https://www.iheart.com/podcast/256-podcastona-43099114/ TuneIn – https://tunein.com/podcasts/Podcasts/PodcastONA-p1249922/ Stitcher – https://www.stitcher.com/podcast/podcastona/ Where to find us: Alex – @AuraOfAzure Andrew – @MangaMan9000, youtube.com/DubTalk Jet – @Divinenega,  youtube.com/DubTalk Duelist – @HeartofSword75, youtube.com/DuelistG As always, check out surrealresolution.com for more content, and follow @SurrealReso for more updates on the show, our continued news posts, reviews, and our fellow podcasts.

Josh Allen and Joe Lynch discuss Tive's validated, real-time visibility for pharma. Josh is CRO at Tive, a leading provider of real-time supply chain visibility insights that help logistics professionals actively manage their in-transit shipments' location and condition. About Josh Allen  Josh Allen joined Tive in April of 2022 as Chief Revenue Officer to build out the go-to-market team as the company continues to scale at a rapid pace. Allen's primary responsibilities include fortifying the long-term global sales strategy, hiring the required expertise across the team, driving aggressive revenue growth, and creating a culture of winning. He joined Tive after serving as CRO at two fast-growing Boston-based technology companies in Owl Labs and Drift (acquired by Vista Equity Partners). Prior to that, Allen served as SVP, North America Sales & Service at CarGurus (NASDAQ: CARG) where he led a team of more than 300 sales, service, and operations professionals during the company's most expansive growth period. He also spent a decade at LogMeIn (NASDAQ: LOGM), where he held a number of leadership positions, including VP of Sales for two of the company's three business units, and helped open and expand their international headquarters in Dublin, Ireland. Josh attended Bowdoin College and now lives in Lynnfield, MA with his wife and two daughters and spends any extra time he has coaching, training, playing music, or sharing stories with friends and family. About Tive Tive is a leading provider of real-time supply chain visibility insights that help logistics professionals actively manage their in-transit shipments' location and condition. With Tive, shippers and logistics service providers (LSP) eliminate preventable delays, damage, and shipment failures. Tive‘s solution provides data generated by its industry-leading trackers allowing clients to actively optimize their shipments, improve their customers' experience, and unlock supply chain insights in an actionable real-time manner. Key Takeaways: Validated, Real-Time Visibility for Pharma Josh Allen is the Chief Revenue Officer of Tive, a tech firm that provides location and condition data of critical shipments in real time to ensure on time and in full delivery. In the podcast interview, Josh and Joe talked about Tive's validated, real-time visibility solution for the pharmaceutical and biological industries. The pharma and biological industries require visibility solutions to comply with exacting regulations – and Tive meets those requirements. Tive's pharma compliance is outlined below: FDA 21 CFR Part 11 and EU Annex 11 compliance: Ensures electronic records can be trusted in the same way as handwritten records. 3-Point NIST® traceable Certificate of Calibration included with every Tive tracker: Tive Solo 5G trackers and probes are fully calibrated by an ISO 17025 accredited laboratory. GxP-compliant: Tive's solution follows the guidelines of Good Manufacturing Practices (GMP). All the components (hardware and software) are developed and tested following the Good Automated Manufacturing Practice 5 (GAMP 5) model. The bar is higher for medical and pharmaceutical shipments because a shipment that is late or out of temperature range could cause loss of life. The Tive Tracker is about the size of a deck of cards, and it captures and transmits shipment data in real time with unprecedented accuracy. The Tracker provides real time alerts that enable shippers and their 3PL partners to respond and recover the shipment in the case of temperature breech, tampering, shock, damage, theft, and a variety of other factors. Tive enables shippers and their carrier partners to move from reactive to proactive, which is so important when transporting medical/pharma shipments. Tive provides flexible, scalable solutions bringing end-to-end visibility to supply chain professionals. In additional to medical and pharma, Tive provides solutions for the following supply chain problem areas: Location Tracking for High-Value Goods Chemicals Condition Monitoring Handling Damage Monitoring Damage Alerts for Electronics Shipments Port Delays Environmental Monitoring for Perishables Equipment Delivery Monitoring Automotive Supply Chain Optimization Learn More About Validated, Real-Time Visibility for Pharma Josh on LinkedIn Tive on LinkedIn Tive website Tive pharma solution page Biocair case study Optimize Courier case study Mercury case study Tracking Medical Shipments with Alex Guillen The Tive Story with Krenar Komoni The Logistics of Logistics Podcast If you enjoy the podcast, please leave a positive review, subscribe, and share it with your friends and colleagues. The Logistics of Logistics Podcast: Google, Apple, Castbox, Spotify, Stitcher, PlayerFM, Tunein, Podbean, Owltail, Libsyn, Overcast Check out The Logistics of Logistics on Youtube

Regulations regarding chemical software and data can be intimidating. What is software validation? How does that relate to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)? It all begins to sound like legal mumbo jumbo.Luckily, we can help demystify GXP. Dr. Karim Kassam has helped many clients implement ACD/Labs software in regulated environments. In this episode, he will answer common questions about how these different forms of regulation fit together.Brought to you by ACD/Labs: www.acdlabs.com

Product quality management is one of the most difficult and time-consuming undertakings in the workplace today. In this podcast Jon Beckstrand, CEO of MasterControl, details how his company's offerings expedite and improve the efficiency of the quality management process. MasterControl's GXP compliance software, quality in electronic manufacturing (QEM) systems, document control software, and their many other offerings are the solution to all your processing problems.

Product quality management is one of the most difficult and time-consuming undertakings in the workplace today. In this podcast Jon Beckstrand, CEO of MasterControl, details how his company's offerings expedite and improve the efficiency of the quality management process. MasterControl's GXP compliance software, quality in electronic manufacturing (QEM) systems, document control software, and their many other offerings are the solution to all your processing problems.

Webcast URL: https://knowledgewebcasts.com/know-portfolio/biotech-biopharma-organizations/ Early-stage life sciences organizations face many challenges, but planning and implementing IT doesn't have to be one of them. Discover powerful tools and techniques to help you set priorities and make decisions with confidence. Follow key principles and techniques to ensure you make the right investments at the right time with partners that are the best possible fit for your organization. Learn how to build a strategic IT roadmap, define roles and responsibilities, and establish processes to make successful software investments. A right-sized regulatory compliance program lets you implement your GxP or SOX applications efficiently, mitigate risks to patient safety and product quality, and prepare for inspections. Achieve greater cyber maturity with privacy frameworks and safeguard privacy as your business grows in size, value, complexity, and capabilities. This webinar will help you to rethink your challenges and develop an IT strategy from the pre-clinical phases through commercialization. For any more information please click on the webcast URL at the top of this description.

Episode 18 of the Modern Chemistry podcast features Dr. Sebastian Gross. Sebastian is a consultant at Wega IT, (https://www.wega-it.com/en/). Where he supports clients, using his advanced experience in biotechnology methods, bioprocess development, lab & assay automation and kinetic modelling. Sebastian has strong experience in tools like Liquid Handling station, SiLA, Python, MATLAB, LabVIEW, SQL, and Data modelling.Prior to Wega, Sebastian was head of process development at TUB (Technische Universität Berlin), where he also did his PhD. Sebastian is contactable on social media, and you can find him on LinkedIn at https://www.linkedin.com/in/sebastian-hans/You can also connect with Sebastian via the Wega website link above.Sebastian's web linkOur theme music is "Wholesome" by Kevin MacLeod (https://incompetech.com)Music from https://filmmusic.ioLicense: CC BY (http://creativecommons.org/licenses/by/4.0/) Connect with me (Paul) at https://www.linkedin.com/in/paulorange/H.E.L. group can be found at www.helgroup.com online,on LinkedIn at https://www.linkedin.com/company/hel-group/ on Twitter, we're @hel_group, https://twitter.com/hel_groupor search for us on Facebook 

This week, Kelly Simpliciano hosts a discussion on GXP inspection principles and the changes in processes and expectations stemming from the Covid-19 pandemic. More work than ever is being completed by virtual connections, remote activities, and through systems and processes more reliant on collaborative team efforts and digital technologies. Understanding how these elements affect our inspection preparedness, as well as our day-of-audit activities, is critical to a successful site visit. Be prepared for virtual site visits and audits to become the norm. About Our Guest: Kelly Simpliciano Associate Director, Research Development Quality - Clinical Trials Systems & Auditing QA Bristol-Myers Squibb. Kelly has been with Bristol-Myers Squibb since 2003 when she joined as a QA analyst. Kelly achieved her MS, Quality Assurance and Regulatory Affairs in 2018. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.  This episode is brought to you by IVT Network's Validation Week.

In this podcast episode, our guest is Troy Fugate, a pharma industry and GMP veteran with 30+ years of experience in the field. Now, he is the Vice President at Compliance Insight, Inc. They help businesses overseen by the FDA navigate the regulatory process, achieve compliance, and develop best practices for manufacturing innovative drugs, medical devices, and biologics. Troy believes that the single most challenging issue leaders face is incorporating GMPs into their company culture. The leaders don't know how to blend GMPs into their mission and vision with the right passion. Only then can employees see the whole vision and understand the "Why". Not just to do things because "it's required by the GMPs" but to see the value in those actions. Listening to the podcast or watching the clip, you will learn: How to establish a unified quality mission across a pharma organization Why some people see GxP as a hurdle, and how to change that Why using KPIs wrong can cost you your best employees How to Deliver Effective and Measurable GMP training ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at https://podcast.qualistery.com/infusing-gxps-into-your-organizations-dna ------------------------------------------------------------------------------------------------------ This episode is Sponsored by Dot Compliance, the industry's first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier. #Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this Tech Blast episode, Tim Bolus, Compliance Program Manager at Molecular Devices, provides a 15-minute in-depth exploration of the regulatory landscape of drug discovery and development. Tim examines the good lab and manufacturing processes essential to successful drug discovery, development and production. Get Tim's insight into the field and discover how to best prepare your lab to pass the FDA's regulations and hear some firsthand cautionary tails! Contents: Introducing GXP: 00:40-2:20 Why is GLP important in drug development? 2:20-05:55 Why is GMP important in the manufacturing processes late down the line? 05:55-07:15 Examples of GXP going wrong and the ramifications: 07:15-10:30 Solutions to ensure GXP: 10:30-11:40 Aspects of GLP that need improving: 11:40-13:40

This week, Stacey presents the 2021 IVT Awards and interviews the recipients of each award. The awards being presented are Author of the Year for the Journal of GXP Compliance, Author of the Year for the Journal of Validation Technology, Podcast of the Year, Speaker of the Year for Validation Week, Speaker of the Year for Compounding Pharmacy Compliance, Speaker of the Year for Computer Systems Validation and Software Assurance, and the prestigious Chapman Award. During this presentation, you will hear from Ron Schardong, Valarie King-Bailey, Richard Wedlich, Kurt Moyer, Steve Thompson, Dr. Ross Caputo, and Dr. Paul Pluta. The team at IVT Network, together with our Esteemed Advisory Board, are proud to announce the recipients of the 2021 IVT Awards. These annual awards recognize the outstanding authors, speakers, podcast guests, and presenters, who keep our audience informed and forward-thinking. Nominees for the author of the year (both JVT and GXP) are selected by their peers, based on articles published and topics covered, which have been integral to learning and knowledge share across industries throughout the year. The podcast of the year is presented to the individual or panel receiving the greatest number of downloads and listens. Finally, our speakers of the year are selected by vote from attendees of the sessions as the most impactful and engaging in their presentations for the associated event. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

This week, Stacey is joined by Ken Shitamoto to explore critical thinking in the systems validation department and share concepts and case history. Most industry folks have heard about CSA and understand the basics behind the shift in priorities. What's better left to understand is the if's and how's around adoption and implementation within our own organizations. A risk-based approach is nothing new. However, the evolution centers on a risk-based approach using critical thinking, with a focus on assurance needs, testing activities for our higher-risk activities. About our Guest Ken Shitamoto, MS Senor Director, IT, Gilead Sciences Ken leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

What do you know about cleanrooms and why they are used in the pharmaceutical manufacturing space? How does the need for them impact your ability to get a facility operational and ready for "gametime"? If you are an early phase manufacturer, how do you make sure you protect your IP as you move forward with initial process development? On today's podcast, Ravi Samavedam, President and COO of Azzur Cleanrooms on Demand and I discuss the basics of cleanrooms, why they are used, where they are used, what they look like, the different ways they are implemented, and more. The industry continues to get more efficient at setting up manufacturing facilities and new technologies help enable this. Unfortunately, it isn't that easy. Sometimes the time to get from the lab to small scale GMP manufacturing is prohibitive and and the line to get on the CMO roller-coaster is just too long...another solution is needed. Learn more about how Azzur has started helping their customers set up "Cleanrooms on Demand" so that they can get to where they need to be quickly and minimize the capital and resources needed to get there. Early-phase manufacturers face a myriad of challenges when it comes to starting up and scaling out: Need for clinical manufacturing capability Lack of GxP expertise Limited quality management systems Lengthy facility design-build timeframes Insufficient warehouse and materials storage Truly unique to the industry, Azzur's hybrid model allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs). Join us to learn about cleanrooms AND what Azzur is doing different. Learn more about Azzur Cleanrooms on Demand Here! Say Hi to Ravi on LinkedIn! http://www.modernbiopharma.com or our LinkedIn Page Say hi to me, Jesse, on Linkedin

Augmented reveals the stories behind the new era of industrial operations, where technology will restore the agility of frontline workers. In episode 31 of the podcast, the topic is: Pharma 4.0. Our guest is Michelle Vuolo, Quality Practice Lead, Tulip.In this conversation, we talk about GxP, the collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution, specifically in the context of emerging digital technologies that promise to improve efficiency, so-called industry 4.0 or, in this case, pharma 4.0 technologies.Augmented is a podcast for industry leaders and operators, hosted by futurist Trond Arne Undheim (@trondau), presented by Tulip.co, the frontline operations platform, and associated with MFG.works, the industrial upskilling community launched at the World Economic Forum. Each episode dives deep into a contemporary topic of concern across the industry and airs at 9 am US Eastern Time every Wednesday. Augmented--the industry 4.0 podcast--industrial conversations that matter.After listening to this episode, check out:Tulip: https://tulip.co/Michelle Vuolo: https://www.linkedin.com/in/mtullie/Trond's takeaway: Pharma 4.0 has to be executed with a diligence unseen in the software industry, which also explains why change has taken a while to come to pass. Now that the industry is taking on board the promise of such technologies, it also has to document its effects. The impact on digital technologies should be positive although it will not be without frustrations for those who want quick wins.Thanks for listening. If you liked the show, subscribe at Augmentedpodcast.co or in your preferred podcast player, and rate us with five stars. If you liked this episode, you might also like episode 33, Sustainable Manufacturing at Scale, episode 23, Digital Manufacturing in the Cloud, or episode 17, Smart Manufacturing for All. Augmented--industrial conversations that matter.

Grainne Lynch, Senior Manager and Traceability Lead for Accenture, helps pharmaceutical companies be compliant with supply chain legislation around preventing counterfeit medicines from entering the supply chain. Her expertise is around helping pharmaceutical manufacturers implement common capabilities and coding to allow tracking and tracing of products at the unit level. On this episode, Grainne explains to Greg that the pharmaceutical industry is on the forefront of a consumer-led trend demanding the ability to track and trace products end-to-end throughout the supply chain. Now more than ever, consumers want to know a product's entire history—where it came from, how materials were sourced, where and when it was manufactured, and the process by which it was approved. And, consumers expect companies to be responsible for making good decisions throughout the supply chain. This trend toward greater tracking and tracing is being seen in many industries, and as Grainne explains, life sciences is a natural leader because the industry already has GxP requirements in place. Data and analytics of course play a critical role. For example, most pharmaceutical products require refrigeration, and devices are used to monitor and measure refrigeration throughout the supply chain to ensure the proper temperature level is maintained. Grianne leaves us with her thoughts on the importance of pharmaceutical traceability to the future growth of the industry as a whole. 

In this episode, Stacey is joined by Steve Thompson to discuss some of the key topics from the recent CSV panel on "Digital Transformation Initiative." The panel shared first-hand experiences of point solutions, and platform transitions, as well as lessons learned from migration to cloud computing and cloud first approaches. Steve will share his expertise on some of the ideas and concepts shared in the discussion.  About Our Guest: Steve Thompson has over 20 years of experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies, including biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003 and is a regular speaker on industry trends and best practices. Steve received a Bachelor of Science, Computer Information Systems, degree in 1986. He can be reached at steven.thompson@valgenesis.com     Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

Today's guest is Lisa Helmonds, Vice President of Quality Services and Operations at MWA Consulting, which helps companies bring life-saving products to market and scale successfully. Lisa has more than 30 years of training in the areas of manufacturing and quality assurance for the pharmaceutical, biotechnology, and medical device industries. Also, she has extensive "good practice" (GxP) knowledge of quality guidelines and regulations. She works with several startups and established companies to implement or improve quality systems and procedures.Lisa understands the challenges that industries deal with today. She describes a day-in-the-life of a quality consultant, innovations, and advice to life science entrepreneurs everywhere. Lisa has seen it all and offers some useful takeaways from her insights. Show Notes: Lisa Helmonds on LinkedInMWA ConsultingBioMarinGenentechU.S. Food and Drug Administration (FDA)FDA - Form 483 Warning Letter or Inspection ObservationFDA - Guidance DocumentsApplication to be on the show: From Lab to LaunchQualioMusic by keldez

En este cierre de temporada hablamos de todo lo que falla con el humor, la autocensura mata la comedia y esa horrible sensación de que alguien repita tu chiste en voz alta. Javi hace ecuaciones matemáticas para explicar el efecto del humor, no sirvieron de mucho. Se vale reírse del humor, ya le toca ser el blanco del chiste. También nos puedes escuchar en Spotify, Apple Podcasts, Google Podcasts y demás plataformas digitales. Pueden darnos su bonita suscripción en YouTube: https://www.youtube.com/channel/UC6mi6vCG8MfX4jpOEvAEpEQ?view_as=subscriber Síguenos: https://www.instagram.com/porparticipar https://www.twitter.com/porparticipar https://www.facebook.com/porparticiparpodcast https://www.instagram.com/dimexoch https://www.instagram.com/aledunnet

EP41 | El incómodo fracaso de no poder decir “no” Ft. Isabel Sesma. En este episodio hablamos sobre cómo el mexicano culturalmente no puede decir no, gracias conquista. No solo no sabemos decir no, tampoco podemos aceptar un “no”. Deja de molestar a tus amigos si no quieren ir a un plan. Se vale reírse del no, total ni lo decimos. También nos puedes escuchar en Spotify, Apple Podcasts, Google Podcasts y demás plataformas digitales. Pueden darnos su bonita suscripción en YouTube: https://www.youtube.com/channel/UC6mi6vCG8MfX4jpOEvAEpEQ?view_as=subscriber Síguenos: https://www.instagram.com/porparticipar https://www.twitter.com/porparticipar https://www.facebook.com/porparticiparpodcast https://www.instagram.com/dimexoch https://www.instagram.com/aledunnet

Diego nos habla de cual sería su sistema político ideal. El capitalismo es el enemigo de la humanidad, Ale siente nostalgia por la Unión Soviética mientras que Diego nos cuenta por qué podría ser la peor pesadilla del ser humano. Concluimos que una sociedad sin dolor solo produce pinturas con naturaleza muerta. Se vale retírese del sistema político, al final ni funciona. También nos puedes escuchar en Spotify, Apple Podcasts, Google Podcasts y demás plataformas digitales. Pueden darnos su bonita suscripción en YouTube: https://www.youtube.com/channel/UC6mi6vCG8MfX4jpOEvAEpEQ?view_as=subscriber Síguenos: https://www.instagram.com/porparticipar https://www.twitter.com/porparticipar https://www.facebook.com/porparticiparpodcast https://www.instagram.com/dimexoch https://www.instagram.com/aledunnet

Ale y Xoch coinciden en que jamás seremos independientes, tanto que ahorita dependen del internet para apreciar este episodio. En el fondo dependes de un amigo, un amor o del dinero de tus papás. La independencia es un cuento folklórico, pregúntenle a Escocia. Se vale reírnos de la independencia, nunca la obtendremos. También nos puedes escuchar en Spotify, Apple Podcasts, Google Podcasts y demás plataformas digitales. Pueden darnos su bonita suscripción en YouTube: https://www.youtube.com/channel/UC6mi6vCG8MfX4jpOEvAEpEQ?view_as=subscriber Síguenos: https://www.instagram.com/porparticipar https://www.twitter.com/porparticipar https://www.facebook.com/porparticiparpodcast https://www.instagram.com/dimexoch https://www.instagram.com/aledunnet

Episode 5 of the I Am IMA podcast is live, and features a great interview with Newcastle University Quality Assurance manager Lulu Cvetkovic. Lulu discusses the challenges in moving from a career in Pharma to academia, and what scientists in academia can take from the world of GxP to improve their day to day research.

Digitization Of Validation For Effective Off-Site Regulatory “Review” And “Inspection” This week, Stacey is joined by Ajaz Hussain, Alton Johnson, and Steve Thompson. As agencies like the FDA continue to rely on virtual inspection, we need to take a look at the process, including a review of documents and processes. How can these inspections be more hands-on and eyes-on, allowing for efficient and accurate outcomes?Resources from this episode Article - https://www.ivtnetwork.com/article/digitization-validation-effective-site-regulatory-%E2%80%9Creview%E2%80%9D-and-%E2%80%9Cinspection%E2%80%9D Dr. Ajaz Hussain, Ph.D., Advisory Board Chairman, ValGenesis, Inc.Dr. Hussain is globally recognized for his tireless efforts to improve the predictability of medicinal product development, manufacturing, and associated regulatory processes. As the Deputy Director Office of Pharmaceutical Science, he led some of the U.S. Food and Drug Administration's major initiatives to develop regulatory policies that already have and will continue to have, a significant impact on product development and approval in many geographies. His corporate experience includes leadership of the development and/or regulatory submissions of first-in-class Biosimilar, Follow-on Protein, and Complex Generic products at Sandoz. At Philip Morris International, he took on the challenge of higher levels of uncertainty (regulatory and business) and product complexity to build strategies and systems to successfully move forward development programs on plant-based vaccines, products for tobacco harm reduction, and ensure the credibility of scientific evidence to seek regulatory discussions and submissions. His experience at Wockhardt has helped him to understand the opportunities and talent companies in India have, the challenges they face, and how they can bring forward effective solutions to maintain and enhance competitiveness and credibility. He also has extensive teaching experience, he served as a tenured Associate Professor of Pharmaceutics at the University of Cincinnati, where he established a research program on Computer-Aided Formulation Design. Based on his broad experience in academia, US FDA, and industry he founded his consulting practice Insight Advice & Solutions LLC.Alton Johnson, Ph.D., Alton Johnson Consulting, LLCAlton Johnson is an industry leader and expert in pharmaceutical development, manufacturing, technology, and business solutions. In his current consulting role, he develops strategies and solutions for clients in the areas of new product development, manufacturing, digital transformation, pharmaceutical technology, business development, and compliance. He has 30-plus years of leadership experience at Pfizer across, Technical Services, Innovation, and Advanced Manufacturing Technology / Pharma 4.0. His extensive publications and presentations encompass Quality by Design, Risk Management, Knowledge Management, Validation, Process Analytical Technology, Continuous Processing, and Pharma 4.0, for organizations including ISPE, DIA, PDA, and AAPS. He has served in leadership roles for PhRMA, on the board of Smart Manufacturing Leadership Coalition, and as Chair of the Steering Committee for NIH-sponsored Engineering Research Center.Steven D. ThompsonSteve has over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that include biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003, and is a regular speaker on industry trends and best practices.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

The FDA Group's CEO, Nick Capman, sits down with Ben Locwin, Senior Consultant for Public Health Outreach at the CDC, and Executive Advisor for Valeocon Management Consulting, to discuss what life science leaders should expect from the FDA in 2021 as it pertains to quality system management, regulatory approvals, GxP compliance, and more. Ben has extensive experience working with the FDA and international regulatory officials. His project work includes Pre-IND, NDA, Ph1-3, and marketed/post-market drug products, as well as PMA and 510(k) medical devices. Ben has trained FDA inspectors within their headquarters and has participated in the design of the FDA's Global Quality Metrics Initiative. Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started: www.thefdagroup.com.

GxP are joined by fellow friends-turned-business partners, Brittany Snow (Pitch Perfect franchise) and Jaspre Guest, to celebrate their new passion project, September Letters - a mental health awareness and letter writing experience. This episode and conversation is uplifting, hopeful, vulnerable, and filled with gratitude. Just in time for Friendsgiving. Brittany also reveals that she is...wait for it...a Powdered Donut #lightningWAFF Anyone can write a September Letter by visiting septemberletters.com. Follow September Letters on instagram @septemberletters --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/whatarefriendsfor/message Support this podcast: https://anchor.fm/whatarefriendsfor/support

Elevated Signals started on the ground, partnering with a cannabis company in Vancouver and building solutions in their greenhouse. Now, the GxP manufacturing software company is breaking into the U.S. market. Amar Singh, Liam Polsky, and Hardeep Shoker join the podcast to talk about software, social impact on agriculture industries and more.Connect with Elevated Signals: LinkedInInstagramTwitter Elevated Signals Connect with us:imwithrj.comInstagramTwitter 

On this episode of Life Sciences Accelerated, we invited USDM’s Vishal Sharma, VP of Digital Transformation, and John Petrakis, VP of Cloud Assurance, to talk about how to manage your regulated GxP workloads in the public cloud. John holds 30 years of global industry experience in business transformation, delivering solutions that address regulatory and quality pressures. He’s led all aspects of strategy development, delivering value for pharma, biotech, medical device, and healthcare companies. Vishal has spent more than 20 years in life sciences, developing core competencies using emerging technologies to help customers fast-track their digital transformation and achieve high-impact business outcomes.  What we discussed: The transition from on-premises technologies to the cloud How cloud computing evolved from traditional IT to new service models How regulatory requirements have affected the adoption of newer technologies New things to do with tech like Microsoft Azure, Google Cloud Platform, and AWS Advice for life science companies considering moving to the public cloud Find this interview and many more by subscribing to Life Sciences Accelerated, on Apple Podcasts, Spotify, or our website.

In this episode, Stacey hosts a panel discussion on computer software assurance. Stacey is joined by industry experts, Raechelle Raimondo, Ken Shitamoto, Pritam Khade, and Senthil Gurumoorthi, to talk about the upcoming guidelines from the FDA on computer software assurance, testing requirements, IT automation, risk, quality culture, and critical thinking mindset in the industry. Raechelle Raimondo - Raechelle has more than 20 years of experience working for large/global corporations, small businesses and start-up companies. A proven history of implementing global systems utilizing a risk based systems lifecycle (SLC) approach and managing teams to support multiple projects, including forecasting and managing budgets. Strengths include leadership, portfolio/program management, delivering results, managing multiple priorities, effecting change, building teams, problem-solving, using interpersonal skills to build effective relationships, and understanding the link between technology & business needs to deliver compliant solutions that optimize processes & efficiencies. Ken Shitamoto - Ken Shitamoto leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease. Pritam Khade - Pritam is a Director of Global Quality Compliance at Allergan Inc. Senthil Gurumoorthi – Senthil is a Director of IT Services at Gilead Sciences. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

In this episode, Stacey is joined by Steve Thompson, Director Industry Solutions, to talk about how digital technology is changing the life science industry. Stacey and Steve discuss paperless systems, remote validation, and eLogs.Steve has over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that includes biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003, and is a regular speaker on industry trends and best practices. Steve received a Bachelor of Science, Computer Information Systems, degree in 1986.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

In this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor. Jennifer talks and gives practical advice on how to perform a successful supplier or internal audit from start to finish. Here are some of the topics we covered in our talk:

In this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor. Here are some of the topics we covered in our talk: ✅The Art Behind Being a Great Auditor ✅The Biggest Challenges of an Auditor ✅Why Companies Should Be Here Is Why Companies Should Be Happy to Be Audited ✅The Best Thing About Auditing ✅Why the Opening Is So Important for a Successful Audit ✅Knowing the Scope Is the Foundation of the Audit ✅The Most Common Mistakes of Audit Preparations- ✅Expert Tips for Junior Auditors on How to Learn Their Standards Jennifer served as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant with expertise in GCP/GVP/GMP/GDP.

Welcome to the 38th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode is a little different than usual. Philippe Gaudreau will be joining Mandy as a co-host in a conversation with guest expert Ben Locwin. Ben is the SVP of Quality at Lumicell and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. This week, they are discussing Data Integrity and Data Governance in today’s landscape. Ben explains the difference between data integrity and data governance, discusses the challenges of remote work during COVID-19 from a GxP perspective and breaks down some tips for companies to incorporate work from home in their company culture in a safe and efficient way!   Key Takeaways 0 :33 : Mandy introduces today’s co-host Philippe Gaudreau. 1:22 : Mandy introduces today’s guest, Ben Locwin. 2:15: Today’s topic is Data Integrity and Data Governance in today’s remote work culture. 3:02: Ben provides an overview of his background in Life Sciences. 9:15: Ben explains the difference between data integrity and data governance. 9:50: The guests discuss the unique challenges for handling work from home and COVID-19 from a GxP Data Integrity perspective? 11:57: Philippe details some of the dangers for data integrity with employees working from home and shares his opinion on the future of online security. 14:31: Ben stresses the importance of the Quality / Regulatory and IT / Security team members work hand in hand to ensure the integrity of data. 17:15: Ben discusses the delicate balance between ease of use and standardization of inputs and outputs within software. 20:14: The group discusses tips and tricks for remote workers to improve their efficiency. 23:39: Ben insists on the importance of having a routine on the human psyche. 26:10: Mandy insists on the importance of recording important meetings to keep track of information 27:28: Philippe gives some tips for companies to incorporate work from home in their company culture in the long term. 30:27: Mandy suggests reviewing data governance policies and ensuring that the team is comfortable with working from home. 31:55: Ben stresses the importance of having clear data governance policies in the future. 33:53: Mandy thanks Ben and Philippe and reflects on today’s learnings.   Mentioned in this episode Ben Locwin on LinkedIn Mandy.Podcast@Solabs.com

Building a successful career in pharma is complicated and requires specific tools, knowledge, and traits. But you can do it with any educational background if you have a healthy hunger for knowledge. Jennifer Kussauer studied communication. Nonetheless, she built a fantastic pharma career and functioned as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant. In this podcast episode shares how she managed to build a great career without scientific education. We also dive into the fascinating world of GXP audits. The full video of our talk will be available from Monday 08.06.2020 on www.qualistery.com.

Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, and John Patterson, Senior Consultant QACV Consulting, to the show. Today, Stacey, John and Chris will be discussing how to run a successful virtual audit during the Covid-19 pandemic.How to factor in audits into a changing schedule during a pandemicWhat goes into the decision to do a remote audit instead of on-site?What are the regulatory guidelines for virtual audits?What factors need to be considered when you do remote audits vs on-site?What needs to be performed before handling a remote audit?How can you overcome the limitations of a remote audit?How will the Covid-19 pandemic change the processes of audits moving forward?How can you have the best virtual audit experience?John is a technology savvy leader, focused on improving human health through the compliant and secure enablement of new business technologies, particularly GxP, IT/digital systems. John is experienced in IT GxP Inspection readiness and Quality Management Systems (QMS) development, Cyber Security and Data Protection, Vendor Audit Planning, Preparation, Execution & Response, Standards Interpretation, Development & Governance, Data Privacy Enablement and Compliance, Strategy Development, Organizational Design & Governance, Records Management & E-Discovery Compliance, and Emerging IT/Digital Tech (e.g. Cloud, Mobile) Regulatory Surveillance & Advocacy.Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

In today’s episode, your host Philippe Gaudreau, the CEO and founder of SOLABS, is joined by a frequent guest of the show — Gretchen Dixson, the Senior Product Specialist and Head Trainer at SOLABS!   Today, they will be taking a look the Deviations Process App (P0054) used for deviations in the context of the GxP pharmaceutical environments. Gretchen covers the main steps within the deviation process and what they’re being used for,  the items that are linked to deviation, which reports are available for this process, whether or not deviations can be used for lab investigations, and where to learn even more about this process after listening to the show!   Key Takeaways: [:24] About today’s episode. [:50] Philippe welcomes Gretchen back to the podcast! [1:15] Gretchen explains the main steps within the deviation process and what they’re being used for. [5:35] Gretchen highlights the convenience of initiating a child process (dependent or related) from within an ongoing process. [6:32] What other items are linked to deviation? [7:36] Which reports are available for this process? [9:04] Where users can find more information on this process. [10:06] From Gretchen’s experience, has she seen deviations used for lab investigations? [11:24] Philippe thanks Gretchen for joining the podcast and wraps up this week’s episode! [11:58] Philippe reminds listeners that SOLABS’ new website and knowledge base is now available!   Mentioned in this Episode: SOLABS QM 10 Deviation Process (P0054) SOLABS QM 10 Lab Investigations Process (P0055) SOLABS-Podcast@SOLABS.com  Philippe Gaudreau on LinkedIn Gretchen Dixson on LinkedIn docs.SOLABS.com

On this episode of Pontiac Talk, we learn about how Kevin got into the hobby (...a great story) and how he came to own and operate Ames Performance

Welcome to the 30th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!    Today’s episode is all about inspection readiness and distinguishing what that looks like from both the GMP side and the GCP side. And joining Mandy today is return guest, Nathalie Bourgouin! Nathalie is the Vice-President of Compliance at Skillpad — a sister company of SOLABS — where she leads the Compliance Consulting Group, with a focus on clinical trials and research compliance. She’s a very well-rounded, highly experienced expert in the space with more than 25 years of experience in pharmaceuticals and biotech!    In this episode, Nathalie highlights the key concepts regarding GxP inspection readiness, compares the differences between GMP and GCP inspection readiness programs, explains how a company can better prepare for an inspection, and even highlights some of the issues she often sees coming up in inspections.   Whether you are new to the life sciences space or are a veteran with many years of experience, you will gain something of value in today’s episode!   Key Takeaways: [:28] About today’s episode! [2:35] Mandy welcomes Nathalie to the podcast! [2:46] Nathalie highlights key concepts regarding GxP inspection readiness. [4:14] Nathalie compares GMP vs. GCP inspection readiness programs. [5:05] How can a company get ready for an inspection? [7:59] Nathalie highlights some of the issues that she commonly sees coming up in GMP regulatory inspections. [12:42] How GCP inspections differ from GMP inspections as well as some of the key differences in the inspection process between the United States and Canada. [18:59] Nathalie provides some key tips for preparing for an inspection. [21:23] Nathalie’s tips for preparing individuals on your team for an inspection. [24:45] Nathalie stresses the importance of identifying who your key people will be for the inspection and training them on what they should and should not say. [27:50] Mandy thanks Nathalie for her input on the show and reflects on some of the key learnings.   Mentioned in this Episode: Skillpad Automating Quality Ep. 8: “The Specificities of GCP Quality Systems with Nathalie Bourgouin” Mandy.Podcast@Solabs.com Nathalie Bourgouin’s LinkedIn

On today’s episode, Stacey Bruzzese welcomes Steve Thompson, Director Computer Quality Assurance for Science 37.Stacey and Steve talk about a variety of topics:Why is the FDA’s Case for Quality which launched in 2011 just now being implemented on a more widespread level?What challenges are posed by implementation?Steve walks through the core components of the Case for QualityAlthough it will roll out as a voluntary pilot program, what does Steve see as the progression over the coming months and years?Mr. Thompson has over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that includes biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers.  He is a published author, was certified as a PDA Systems Auditor in 2003, and received a Bachelor of Science, Computer Information Systems, in 1986.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

In this exciting episode we had the great pleasure of interviewing Dan Fritz and Marco Cuomo to hear about the exciting blockchain work they are doing at the pharmaceutical giant, Novartis. In this podcast you will hear about the wealth of experience they have developed by building POCs using Hyperledger, Ethereum and Corda. Dan Fritz role is domain architect for supply chain. His department look at technologies that support supply chain business capabilities. They also look at emerging technologies and how they could be used to leverage and address the business needs. Marco Cuomo is the Applied Technology Innovation Manager and his team is responsible for bringing in new technology into Novartis. He has been looking at blockchain for the last 2 -  3 years and in addition to supply chain has been looking at good use cases for using the technology. Novartis is a global pharmaceutical company with about 100,000 employees in over 100 countries. It has a portfolio of prescription medicines, a generic division, and is increasingly focused on biotech including cellular and gene therapies.   What is blockchain? Marco Cuomo recognises that defining “what is blockchain?” is a difficult question to answer. In Novartis they have developed a “blockchain elevator pitch” to describe what is blockchain internally to their business and to their internal customers. Blockchain is a shared means centrally controlled, distributed ledger. Every partner in that blockchain network has a copy of that ledger and it enables immutable recording of transactions. These transactions track assets without the need for intermediaries. Dan adds that blockchain is a socio technical construct which is designed to be a win-win for all participants engaged within it. This requires a different mindset where all participants are growing the pie together instead of just slicing it up.   Beginning of Novartis journey into blockchain in 2016 The immutability aspect of blockchain is what attracted Dan and Marco to blockchain. Immutability is a key attribute that is desired in the pharmaceutical industry. This is an industry that is highly regulated, it operates under GxP, or good manufacturing, good distribution, good clinical practices, where the traceability of all of the processes and the accountability of all of the processes have to be proven and documented. A shared immutable distributed ledger seemed like the perfect tool in comparison to creating binders of paper that go into an archive for 10 years. From a supply chain perspective, it was the promise that blockchain could provide more efficient transactions, reducing the friction between data silos and organisational silos through a shared ledger. Additionally blockchain could provide the patient control of their own data instead of it sitting with a range of intermediaries. There is the opportunity for creating patient data marketplaces.   The LEGO Mindstorm Truck In 2016, Marco purchased a set of LEGO Mindstorm Truck to create a supply chain scenario where a serialised product is delivered from a packaging line onto a truck which transports it across the supply chain from a pharmaceutical manufacturer, to a distributor, to a pharmacy and ultimately to the patient. At every step of the way the serial number is tracked against the serial number of the previous block to ensure that the medicine hasn’t been swapped or that it is a potential counterfeit. IoT was added to this blockchain with a set of temperature monitors to simulate a temperature excursion where the medicine is outside its standard transportation conditions. Every participant on the supply chain is informed if there is a potential quality issue.   Why blockchain? If a company controls their ecosystem, all of of its suppliers and distributors then maybe a central database approach will work. However, in the case of the pharmaceutical industry, there are hundreds, if not thousands,

Welcome to the 25th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Today’s episode is all about leveraging a risk-based approach to develop, implement, and maintain your IT programs, extending to GxP controls and critical infrastructure. Guest industry expert, Phil Becker, will be joining Mandy today to discuss this topic and to provide guidance!   Phil has over 30 years of experience in the IT field. He’s an industry thought leader who’s held various strategic leadership roles, including Vice President of IT at Acculogix and Fisher Clinical Services, where he was Chief Architect and Developer of the first truly integrated 21 CFR part 11 compliant electronic batch record in the pharmaceutical supply industry. Phil has also developed the industry’s first web-based reporting software integrated solution. His vast experience in the space includes software application development, architecture, design for manufacturing, and regulatory compliance.   With Phil’s extensive background in the IT space and pharmaceutical arena, he will be providing some incredible guidance on what listeners should consider in terms of IT controls, which risk management tools and approaches you should be taking a look at, and other tactical considerations that will help with the developments and enhancements of your IT program and critical process controls.   Key Takeaways: [:35] About today’s episode. [1:50] Mandy welcomes Phil to the podcast! [2:49] How can a risk-based approach be leveraged to develop and implement an IT control strategy to support GxP business systems? [7:52] What are some risk management tools and approaches that are effective to assess the types of critical controls and the level of robustness that’s appropriate for business systems? [17:47] In regards to business continuity, what are some of the key inputs that should be considered for implementing and maintaining the business continuity program? And how can the effectiveness of these programs typically be assessed? [28:14] Mandy thanks Phil for joining her this episode! [30:30] Mandy thanks you all for tuning in for this week’s episode. If you want to get in touch with her, you can contact her at Mandy.Podcast@Solabs.com.   Mentioned in this Episode: Mandy.Podcast@Solabs.com

Welcome to the 23rd episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Today, Mandy is joined by her co-host, Philippe Gaudreau, and return guest from episodes two and ten, Jay Turner! Jay is the CEO and founder of EduJay LLC., and he is a self-proclaimed learning and development ninja! He has devoted his career to improving people, processes, and programs to produce business results. This includes everything from implementing learning management systems, to designing staff development and leadership development programs, to providing executive coaching.   In this episode, Mandy and Jay are discussing innovation to retrovation — an interesting concept about maintaining GTP (AKA Good Training Practices) in a GxP world. Jay gives his expert feedback on the concepts of GTP, explains what he means by “retrovate” and how it applies to training, gives his top three favorite GTPs and how they can be leveraged in the quality space, and also explains how we can effectively innovate in training when we know it’s needed. The feedback that Jay provides in this episode will be incredibly beneficial for listeners who are considering enhancements to their current training and professional development programs. So tune in to get all of his valuable insight on today’s topic!   Key Takeaways: [:32] About today’s episode with return guest, Jay Turner! [2:37] Mandy welcomes Jay back to the show! [2:49] What does Jay mean by “retrovate” and how does it apply to training? [7:12] Jay lists his top two out of three GTPs and how they can be leveraged in the quality space. [14:20] Jay speaks about moving beyond required training and empowering staff members to become a part of the learning function in the organization. [17:50] Jay explains his third favorite GTP. [21:26] How can we effectively innovate in training when we know it’s needed? [28:07] Mandy thanks Jay for joining her this episode! [29:05] Jay gives a quick background about himself and his organization, EduJay. [31:24] Mandy wraps us this week’s episode by thanking listeners for tuning and giving a quick summary of today’s episode!   Mentioned in this Episode: EduJay LLC Jay Turner’s Twitter Jay Turner’s Facebook Jay Turner’s Linkedin Jay@EduJay.com Automating Quality Ep. 10: “Social and Collaborative Learning with Jay Turner” Automating Quality Ep. 02: “Optimizing Compliance When Implementing an Automated Training Solution with Jay Turner” Mandy.Podcast@Solabs.com Retrovate or Retrovation GTP Google VR Oculus Rift Design Thinking

One of my amazing DJs that works for GXP and an amazing guy! --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app Support this podcast: https://anchor.fm/gxppodcast/support

Welcome to the 21st episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Michael de la Torre. Michael is Chief Executive Officer of Govzilla — the leading platform for GxP inspection analytics. As a company, they are leveraging the power of Big Data and Machine Learning to make government data accessible, usable, and valuable to everyone who needs it.   As the life sciences industry continues to evolve, with regulatory compliance remaining a critical factor for success, inspection trends are a tool to help companies to develop and enhance their quality management systems. Additionally, being aware of these current trends is a key factor for developing a robust audit readiness program. If you or your industry colleagues are seeking a good tool to enhance your understanding of inspection trends, you do not want to miss this week’s episode!   Key Takeaways: [:29] About today’s episode. [1:20] Michael introduces himself, his expertise background, and his company, Govzilla. [3:29] Michael speaks about the most important recent FDA inspection and enforcement trends. [7:49] What are the top items cited by the FDA in human drugs? And have there been any changes in the last couple of years? [12:22] Michael speaks about changes in the inspection scope since the issuance of the data integrity guidance in 2018. [16:11] Michael’s take on Cloud-based solutions for the life sciences industry. [18:15] What impact has the FDA had on the market with their efforts on being more open and transparent with their inspections and enforcement data? [22:53] How Govzilla could be incredibly useful for your organization! [23:18] Mandy and Philippe thank Michael for joining them this episode. [25:02] How to get in touch with Michael de la Torre and Mandy Gervasio.   Mentioned in this Episode: Govzilla Michael de la Torre on LinkedIn Mandy.Podcast@Solabs.com

Welcome to the 19th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! This week, Mandy is bringing you the fifth part of the six-part series focused around quality culture, the virtual pharma environment, and supply chain management. As always, she is joined by her veteran guest of the series, Lisa Helmonds! Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry. Today, Mandy and Lisa will be discussing management review and quality metrics. Lisa explains what a management review is, the overall goal of it, what her recommendations are in terms of the type of quality metrics that should be reviewed during the meeting, and how it is important in sustaining a quality culture. Be sure to keep tuning in for future episodes to hear the last part in the series with Lisa Helmonds!   Key Takeaways: [:29] About today’s episode. [1:03] Lisa Helmonds introduces herself and gives some background on her career. [2:26] About today’s topic: management review and quality metrics. [2:42] What is management review? [3:56] Who typically attends a management review from the various functions in the organization? [5:18] What’s the overall goal of a management review? [8:23] Is a management review required or is it voluntary? [12:02] What Lisa would recommend in terms of the type of quality metrics that should be reviewed during this meeting. [15:53] How Lisa sees management review as important in sustaining a quality culture. [22:39] About the last part of the series! [23:46] If you have any questions, requests, or suggestions, you can contact Mandy Gervasio at Mandy.Podcast@Solabs.com. If you have any questions for Lisa Helmonds, you can contact her on LinkedIn.

Welcome to the 18th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   Mandy is excited to bring you the fourth part in the six-part series with Lisa Helmonds about virtual companies in the life sciences space! As a reminder, Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry.   Today, Mandy and Lisa will be focusing on quality culture for this part in the series. Lisa defines quality culture, explains who is responsible for instilling a quality culture, how it is expressed, and most importantly, why it is so crucial to a company’s overall success.   Be sure to keep tuning in for future episodes to hear the last two parts in the series!   Key Takeaways: [:14] About today’s episode. [:49] Lisa gives a quick overview of her background in life sciences. [2:01] About episode 3 and where this episode will be headed. [3:15] Lisa defines quality culture. [5:19] Who is responsible for instilling a quality culture? [8:29] How is a quality culture expressed? [13:04] Why quality culture is important to a company’s overall success. [20:10] How to get a hold of Lisa if you have any questions or comments! [20:25] About next week’s topic.   Mentioned in this Episode: Part 3: “Quality Agreements with Lisa Helmonds from MWA Consulting” Part 2: “Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA Consulting” Part 1: “Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA Consulting” Lisa Helmonds (LinkedIn) Mandy.Podcast@Solabs.com

Welcome to the 17th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   This will be the third part in the six-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry.   Today, Mandy and Lisa are discussing quality agreements for this third installment in the series. Lisa provides some great insight into quality agreements and why they’re such a critical part of compliance and the supplier quality function. She also shares some great tips for employing these agreements in your own organizations and key things to consider in the process.   Be sure to keep tuning in for future episodes to hear the next three parts in the series!   Key Takeaways: [:33] About today’s episode. [1:20] Lisa talks about her experience in the life sciences space. [3:28] What is a quality agreement? And why is it needed? [5:09] What information should a quality agreement contain? [6:44] Some of the main advantages of executing a quality agreement. [9:03] How a quality agreement is different from a technical or commercial master service agreement. [20:05] How often should quality agreements be reviewed and revised? [23:35] Lisa and Mandy close out this week’s podcast! Be sure to continue to tune in for the next three parts of the series! If you have any questions or requests for the show, email Mandy at Mandy.Podcast@Solabs.com. If you have any questions for Lisa, contact her on her LinkedIn.   Mentioned in this Episode: Part 2: “Qualifications and Oversight of Contract Service Providers with Lisa Helmonds” Part 1: “Key Elements of Virtual Life Sciences Companies with Lisa Helmonds” Lisa Helmonds (LinkedIn) Mandy.Podcast@Solabs.com

Welcome to episode 2 of the 6-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry.   Last week’s episode focused on the details of what a virtual company looks like, and the unique advantages and challenges to consider in the virtual framework. In this week’s episode, Lisa, Philippe, and Mandy are diving even deeper into the topic, and discussing qualifications and oversight of contract service providers.   Be sure to keep tuning in for future episodes to hear the next four parts in the series!   Key Takeaways: [:24] About today’s episode. [1:25] Lisa describes the topic for this week’s episode and talks a bit about her background in life sciences. [3:24] Why is the qualification of contract service providers important to managing quality? [6:21] What qualification of a contract service provider entails. [11:06] Tools that are available to determine which contract service providers should be audited along with the frequency of those audits. [15:15] What responsibility does a sponsor have with regard to contract service provider oversight? [20:53] About the third episode in the six-part series.   Mentioned in this Episode: FDA.gov ICH.org - Q7 Good Manufacturing Practice Guide ICH.org - Q8 Pharmaceutical Development ICH.org - Q9 Quality Risk Management ICH.org - Q10 Pharmaceutical Quality System Failure Mode and Effects Analysis (FMEA) Failure Mode, Effects, and Criticality Analysis (FMECA) Fault Tree Analysis (FTA) Hazard Analysis and Critical Control Point (HACCP) Hazard and Operability Study (HAZOP) Preliminary Hazard Analysis (PHA) Lisa Helmonds (LinkedIn) Mandy.Podcast@Solabs.com

Welcome to the first episode back in the new year! Your host, Mandy Gervasio, and her co-host, Philippe Gaudreau, the CEO of Solabs, are back to start a very interesting new series.   Continuing their mission to bring more clarity around the world of quality and automation in the area of life sciences, they’ve invited on a life sciences expert, Lisa Helmonds. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry.   This new series is the first of six parts about virtual companies in the life sciences space. In this particular episode, Lisa digs into the details of what a virtual company looks like and the unique advantages and challenges to consider in the virtual framework.   Be sure to keep tuning in for future episodes to hear the next five parts in this series!   Key Takeaways: [:31] About today’s episode. [1:22] More about today’s episode (the first part of a six-part series!) and today’s guest, Lisa Helmonds. [1:55] Lisa introduces herself and talks about her background and current role at MWA Consulting. [3:38] How Lisa defines a virtual company. [5:47] Some of the advantages of being a virtual company. [7:40] On the flipside, some of the disadvantages of being a virtual company. [12:35] The biggest risks of not managing quality. [17:00] Lisa outlines approaches to successfully managing quality at contract service providers, and key strategies and elements that would allow a virtual company to feel confident that quality is built into these partnerships. [23:42] Lisa gives a preview of the next segment in this series. [25:42] If you have any questions for this week’s guest expert, Lisa Helmonds, please contact her on LinkedIn. If you have any requests for the show or for Mandy Gervasio, you can contact her at Mandy.Podcast@Solabs.com.   Mentioned in this Episode: MWA Consulting Lisa Helmonds (LinkedIn) Mandy.Podcast@Solabs.com

Welcome to the tenth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today, Mandy is joined by her co-host, Philippe Gaudreau, and return guest from episode two, Jay Turner!   Jay is the CEO and founder of EduJay LLC. Jay is a self-proclaimed learning and development ninja at his latest entrepreneurial venture, EduJay! He has devoted his career to improving people, processes, and programs to produce business results — everything from implementing learning management systems, to designing staff development and leadership development programs, to providing executive coaching.   In this episode, Mandy asks Jay a handful of key questions that learning and development listeners will especially appreciate! He explains some of the key benefits of social and collaborative learning platform communities, some examples of technology platforms that could be implemented in a workplace to help drive engagement more efficiently, potential hurdles or barriers that might be posed by the GxP industry if leveraging ELOs, and more! Tune in!   Key Takeaways: [:40] About today’s episode and return guest, Jay Turner. [2:45] Jay introduces himself and explains his current mission with EduJay. [6:16] Jay explains some of the key benefits of social and collaborative learning platform communities. [13:35] Some examples of technology platforms that Jay thinks could be implemented in a workplace to help drive engagement more. [20:22] In Jay’s experience, does he think that employee engagement increases when leveraging social learning tools? [28:40] In Jay’s experience (in non-GxP industries) is the incorporation of external learning objects (or ELOs) a common practice? [32:30] What Jay sees as potential hurdles or barriers that might be posed by the GxP industry if leveraging ELOs. [37:23] Jay’s ideas on how to bridge the gap between GxP industries and leveraging ELOs.   Mentioned in this Episode: EduJay LLC Jay Turner’s Twitter Jay Turner’s Facebook Jay Turner’s Linkedin Jay@EduJay.com Mandy.Podcast@Solabs.com

Welcome to the sixth episode of Automating Quality. Today’s topic is data integrity — a current, hot-topic in the regulated space. Mandy is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends.   Today, Mandy is joined by her co-host (and founder and CEO of Solabs), Philippe Gaudreau. Together, they interview their data integrity expert, Rich Greer. Rich has a ton of insight and expertise in this area, having been in the industry for around 29 years. He’s had varying roles within engineering, validation, and quality.   Rich provides some great takeaways such as: instituting a data integrity program for the first time, re-assessing your current program for opportunities for improvement, common gaps and misunderstandings around data integrity, and more.   Key Takeaways: [:40] About today’s topic and guest. [1:53] Rich gives an intro to his industry background. [3:24] What is data integrity? And what are some key considerations when trying to implement a data integrity program? [7:10] Key factors related to data integrity when considering implementing and maintaining your GxP electronic systems. [8:58] Rich explains some tactical strategies to manage legacy GxP systems. [15:05] Some common gaps and misunderstandings Rich has seen around data integrity and maintaining compliance. [18:38] If data integrity has been compromised, what are some critical actions an organization must take to remediate? [23:26] Summarizing key points from this week’s episode. [24:00] How to get a hold of Mandy and Rich. [24:20] About next week’s episode.   Mentioned in this Episode: GxP Mandy.Podcast@Solabs.com Rich Greer’s LinkedIn Page

Healthcare and life sciences companies often have to adhere to specific regulatory requirements, such as GxP or HIPAA. The ability to treat your application environment as code on AWS lets you iterate faster while adhering to the appropriate regulatory frameworks. In this session, we discuss how DevOps principles can help you achieve your compliance requirements by validating your infrastructure in the same way that you do software. In particular, we discuss common compliance principles, demonstrate how to translate from policies to technical controls, and highlight how our partners are building for GxP and HIPAA.

Implementing stringent security and compliance controls, like GxP, across your enterprise cloud ecosystem, while ensuring the agility of the DevSecOps process requires significant expertise and a lot of time to design, build, and maintain custom operations tooling. In this session, you learn how Turbot used AWS services to simplify IT operations to provide continuous compliance to major life sciences customers. You also hear how life sciences companies like Novartis Institutes for Biomedical Research (NIBR) have become agile, ensured control, and automated best practices using automated policy controls to configure, monitor, and maintain their cloud resources. By doing this, they became more supportive of their researchers' application stack. You also learn how data scientists and core researchers can take advantage of the power of DevOps and cloud computing without compromising enterprise security or data protection requirements.

In dieser Folge spreche ich mit Sandra Garn darüber, welche speziellen Anforderungen die Life-Science-Branchen an Prozess- und Projektmanagement haben. Andere Branchen, andere Regeln. Obwohl sich Business Process Management durch Standards und feste Methoden auszeichnet, gibt es immer wieder auch Besonderheiten oder spezielle Anforderungen, die zu berücksichtigen sind. Vor allem Unternehmen aus den „Life Sciences“, also Pharma-, Chemie-, Kosmetik- oder Food-Industrie, haben oft spezielle Anforderungen an Prozesse und deren Dokumentation. Sandra Garn ist Inhaberin von Garn Consulting und Bauleiter(in) für IT-Projekte. Speziell in der Pharmabranche unterstützt Garn Consulting in Projekten und bei der Einhaltung von GxP-konformen Prozessen. In dieser Folge erzählt sie uns, worauf es dabei ankommt. Inhalt & Themen: 1. Allgemein: das Zusammenspiel von Prozess- und Projektmanagement 2. Spezielle Herausforderungen in de Life-Science-Branchen 3. Tipps und Tricks

GxP is an acronym that refers to the regulations and guidelines applicable to life sciences organizations that make food and medical products such as drugs, medical devices, and medical software applications. The overall intent of GxP requirements is to ensure that food and medical products are safe for consumers and to ensure the integrity of data used to make product-related safety decisions. The term GxP encompasses a broad range of compliance-related activities such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and others, each of which has product-specific requirements that life sciences organizations must implement based on the 1) type of products they make and 2) country in which their products are sold. When life sciences organizations use computerized systems to perform certain GxP activities, they must ensure that the computerized GxP system is developed, validated, and operated appropriately for the intended use of the system. For this session, co-presented with Merck, services such as Amazon EC2, Amazon CloudWatch Logs, AWS CloudTrail, AWS CodeCommit, Amazon Simple Storage Service (S3), and AWS CodePipeline will be discussed with an emphasis on implementing GxP-compliant systems in the AWS Cloud.

AWS CISO Steve Schmidt presents the state of the union for re:Source Mini Con for Security Services. He addresses the state of the security and compliance ecosystem; large enterprise customer additions in key industries; the vertical view: maturing spaces for AWS security assurance (GxP, IoT, CIS foundations); and the international view: data privacy protections and data sovereignty. The state of the union also addresses a number of new identity, directory, and access services, and closes by looking at what's on the horizon.

The INC 5000 recognized The FDA Group as one of the 500 fastest growing companies in America two years in a row. The Boston Business Journal recently recognized The FDA Group as the 3rd fastest growing company in Massachusetts. The FDA Group also has an A+ rating with the Better Business Bureau. The FDA Group is a world-class service organization that utilizes a proprietary talent selection process of Former FDA & Industry Experts, which is amplified by a corporate culture of responsiveness and execution. Headquartered in Westborough, Massachusetts, The FDA Group has 340+ consultants (55 of whom are Former FDA) across 36+ states. Why is The FDA Group in business? The FDA Group's purpose is to empower our clients to bring their life-changing healthcare products to the market and keep them there. How does The FDA Group do it? The FDA Group is able to do this by providing a world-class service experience. The way in which The FDA Group ensures a world-class service experience is by its proprietary talent selection process coupled with its deep-rooted corporate culture that includes 31 Fundamentals. These Fundamentals are the heartbeat of the organization and are focused on four areas: 1. Core Values These values are a cornerstone to our success. 2. Focus on Service These habits help create extraordinary service experiences. 3. The Collaborative Way These practices enable us to work powerfully together as a team. 4. Personal Effectiveness These behaviors help us achieve greater personal, and by extension, organizational success. What does The FDA Group do? The FDA Group is a global leader in GxP auditing, remediation, and regulatory services. Seth Greene is a 6 Time Best Selling Author, Nationally Recognized Direct Response Marketing Expert, and the only back to back to back GKIC Dan Kennedy Marketer of the Year Nominee. To Get a FREE Copy of Seth’s new book Podcast Marketing Magic, and access to a Live Podcast Marketing Training Session go to http://www.UltimateMarketingMagician.com Learn more about your ad choices. Visit megaphone.fm/adchoices

Dr. Andrew Waddell, a seasoned QA pro and director of the Scotland-based GxP consultancy TMQA delivered the keynote presentation, titled “The Challenges Facing Today’s Quality Assurance,” at the 2016 Masters Conference, the annual event for MasterControl enterprise quality management software (EQMS) users in Europe. Drawing from his unique life experiences and 37-year tenure in QA, Waddell examined five lesser-known aspects of QA that challenge the relevance of a nearly 40-year-old regulation (21 CFR Part 58) and point to an exciting new future of quality.