Podcasts about disclaimer podcast

Jiří Zeman je výrobní ředitel pro prvovýrobu ve společnosti Honeywell Aerospace a již druhý ročník porotce na Lean Awards. Je to zkušený a roky ostřílený praktikant metod štíhlého řízení, o kterém kolegové říkají, že je disciplinovaný, oddaný práci a má neustále chuť učit se něco nového. Po absolvování fakulty strojního řízení v Brně začínal ve společnosti CZeika jako výrobní a produktový manažer, poté budoval své praktické dovednosti v oblasti Lean Six Sigma krásných 6 let jako lídr tréningu a projektu pod značkou SC&C Partner a již 13 let působí v Honeywell Aerospace, kde začínal jako Lean expert a po necelých 3 letech postoupil na klíčové místo v společnosti. Disclaimer: Podcast byl natáčen v terénu na konferenci, kvůli čemuž je kvalita zvuku horší, než na kterou jste u nás zvyklí. Věříme však, že nám ji odpustíte výměnou za zajímavé informace. :)

Podcast第53回目は、2024年の予想（パート2）について話しています！2024年の予想:* ハイブリッドappが増える* コミュニティ所有IPのビジネス* ソーシャル/音楽/コンシューマアプリ* 米国大統領とSEC長官の交代から規制緩和モード* （オフチェーン）ポイントがめちゃくちゃ流行るまた、パート1はこちらです。また来月開催するポッドキャストの新年会イベントの詳細はこちらです！* 日時: 1/19(金) 19:00 - 21:30* 場所: Centrum（渋谷）

Podcast第52回目は、以下について話しています。* Shadow* SONA* Pudgy Penguins* 物理の話　

This episode was recorded live from the KENX Medical Device Validation University in Anaheim, CA! This time around, Jason Secola interviews your usual host, Dori Gonzalez-Acevedo to give a conference recap, as well as field some questions submitted by our LinkedIn audience.Tune in as they dive into a variety of topics, not least of which is the world of AI and Software Quality in Medical Devices and the Life Sciences industry. Some key points discussed were the FDA's increasing approval of AI-powered devices, the importance of collaborative education, the criticality of developing a Quality by Design program, and the impact of diverse perspectives in the Life Sciences industry. Discover the keys to innovation, efficient processes, and nuanced risk management in this insightful conversation with Dori Gonzalez-Acevedo and Jason Secola. Share with a friend or colleague and subscribe wherever listen to podcasts!*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Welcome to another episode of Software Quality Today! On today's show, Dori welcomes Natalie Kaminski. Amongst other things, they chat about Natalie's path from QA Tester to CEO of a technology company, and how her background in QA shaped her approach to launching and running a software development company.With more than 20 years of experience in the technology industry, Natalie is a dynamic and resourceful web and mobile technology entrepreneur. She is the CEO and founder of JetRockets, a custom software, web and mobile application development company. She is also the co-founder of OneTribe, an HR management platform for hybrid and remote teams. She lives in Brooklyn with her husband and two daughters.Follow Natalie on LinkedIn here and reach out to let her know you listened! *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Join us in welcoming Richard Lightfoot for his first appearance on the show! Rich leads the sales and business strategy development of OpenText Global Product Authentication Service, or GPAS, in the Americas and is responsible for channel partner and new market opportunities. Dori and Rich have a great discussion around the applicability and importance of GPAS within the life sciences industry. GPAS is based on unit level serialization of finished goods and helps brands protect their products and secure their supply chains through the delivery of innovative analytics and business intelligence - all while creating a new marketing channel in which to engage their customers.Connect with Richard on LinkedIn here and learn more about GPAS here.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

We're back with another episode of Women Leading Validation! This time around Dori sits down with Manager of Quality and Regulatory Affairs at MIMOSA Diagnostics, Rucha Patel. Rucha is passionate about driving continuous improvement in Quality, which is clear in this conversation as they discuss her background in the industry, what she currently does at MIMOSA Diagnostics, and her general approach to not only continuously building on her own skills and knowledge, but also how she applies that mindset to fix and improve quality systems and processes in life sciences.Outside of her professional life, Rucha is passionate about giving back to her home country of India by collaborating with local NGOs and has enjoyed helping to teach rural kids and their parents the importance of education and nutrition as both elements are unfortunately often overlooked in rural parts of India.Follow Rucha on LinkedIn and enjoy this awesome conversation!*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer. This is a joint Podcast production of ProcellaRX and KENX

We're excited to welcome Director of Integrated C&Q and Kneat Services at VEQTOR, Phil Jarvis! Phil is extremely active in the life sciences community and is a staunch advocate for modernization and improvement in our industry backed by a wealth of experience and insights. I have to apologize in advance for the audio. We had a bit of a technical issue when recording this live, but trust me, this conversation is well worth a listen as Dori and Phil dive deep on the importance of digitizing and integrating the entire validation ecosystem.Please follow Phil on LinkedIn here and don't forget to *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Dori welcomes our latest guest, Kimberly Wallbank, to talk all things Quality in FDA regulated organizations. Together they discuss everything from identifying and mitigating risk, supply chain complexities, why cross-team collaboration is important, improving Quality systems to better meet objectives of delivering safe and effective product more efficiently, and everything in between. Kimberly truly brought a wealth of insights to our audience and this is a great conversation for anyone in the industry to listen in on. Kimberly is the Managing Owner and Principal Consultant for Quality Systems Services, LLC. With more than 25 years in the industry, she has diverse experience and expertise in assisting pharmaceutical, biotechnology and medical device companies achieve compliance with FDA, EMEA, ISO and other recognized standards. She applies this experience by collaborating with companies to establish, maintain, and improve their quality systems so they can provide world class healthcare products.  As an industry leader, she navigates the complexities of FDA compliance while maintaining the most efficient processes for their unique business needs and is passionate about developing ways to infuse quality roles into STEM education.Follow Kimberly on LinkedIn here.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer. This is a joint Podcast production of ProcellaRX and KENX

Join us as we welcome Steve Thompson in a special swap-cast episode that will be published here to Software Quality Today, as well as to the soon to be revamped and relaunched podcast from ValGenesis that Steve will be hosting.  Steve is a highly respected, extremely involved figure in the life sciences community and is currently the Sr. Product Marketing Manager at ValGenesis. In this episode, Dori and Steve sat down after several days of the KENX  “Lean Validation – Implementing CSA and Modernizing 21 CFR Part 11” conference to spend some time dissecting the event and some of the content presented. Some themes included where and how 21 CFR part 11 fits into the current landscape relative to its inception in 1997, the state of CSV at many organizations, as well as other relevant industry regulatory codes and guidances that come into play both from an FDA perspective, as well as global equivalents. What two better people to have a conversation to share insights and summarize a content rich event?Follow Steve on LinkedIn here and be sure to check out the ValGenesis podcast upon its triumphant return.In the meantime, please enjoy this episode and don't forget to subscribe, rate, and share.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

In this episode, we welcome VP of of IT Training, Growth & Development at United Wholesale Mortgage, Jillian Mantua. Jillian is passionate about developing and guiding teams through the uncharted territories that come with organizational transitions and rapid growth by leveraging best practices across all industries. She focuses on identifying what and how to do things differently than current day practices, how to bring out the best in employees, and true alignment with organizational values.Tune into hear Dori and Jillian discuss a variety of topics around the importance of fostering and developing growth within an organization to achieve operational efficiencies, and the recipe that United Wholesale Mortgage has developed to do just that.Follow Jillian on LinkedIn here and don't forget to rate, subscribe, and share this podcast with friends and colleagues!*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

In this episode, we welcome VP of of IT Training, Growth & Development at United Wholesale Mortgage, Jillian Mantua. Jillian is passionate about developing and guiding teams through the uncharted territories that come with organizational transitions and rapid growth by leveraging best practices across all industries. She focuses on identifying what and how to do things differently than current day practices, how to bring out the best in employees, and true alignment with organizational values.Tune into hear Dori and Jillian discuss a variety of topics around the importance of fostering and developing growth within an organization to achieve operational efficiencies, and the recipe that United Wholesale Mortgage has developed to do just that.Follow Jillian on LinkedIn here and don't forget to rate, subscribe, and share this podcast with friends and colleagues!*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer. This is a joint Podcast production of ProcellaRX and KENX

Welcome back to another episode! Today, Dori sits down with Sree K, a life sciences industry professional with over 18 years experience that spans roles in testing, validation, IT, Business, and Quality. As an expert in test automation, Sree is a huge advocate for automation in validation and modernizing our approaches to software compliance.Sree is also very active on LinkedIn, providing his followers with unique and insightful life sciences related content, and illustrating what an exciting time it is to be a part of this industry.You can follow Sree on LinkedIn here, but in the meantime, put in your earbuds and enjoy another great episode of Software Quality Today!*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

This episode we are excited to welcome to the podcast Danielle Duran, Director of GxP Compliance and Training at Aimmune Therapeutics! As fellow advocates for education and continuous enablement in life sciences, Dori and Danielle share their insights on the current state of learning in our industry, and where we can do better to support more effective outcomes in IT and Quality organizations.Listen in now to learn more a bout leveraging effective learning to support quality culture, shifting towards effectiveness measures of training, and, perhaps most importantly, moving towards a people-centric learning model as part core business operations.Enjoy the episode and please don't forget to rate, subscribe and share! *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

***Disclaimer: Podcast contains explicit language*** This is Episode 2 with J. J has many creative pursuits, but in my opinion Music is his favorite. He is a FANTASTIC guitarist. Proof of his talent: all of the “J Series” episodes feature music made by him and most of them were written and recorded right on the spot, no prior planning. He also recorded, mixed, and produced all of the J Series Cannon Dispatch podcast episodes. His musical genre interests range from metalcore to RnB, death metal, hardcore, anything melodic, alternative, and beyond. This episode we talk about his journey into music, influences, writing, creativity, imposter syndrome, and more.Here's my favorite original composition from him called “Isolated”. It slams. Here's his Youtube Channel. And here's his dog who was a guest producer of this episode: - - - -If you liked the episode, these simple things help out BIG TIME:* Give a star rating on Spotify* Give a star rating AND comment on Apple Podcasts* Buy me a coffee* … Most of all, SHARE with someone you think would like it! As always, thanks for listening! Get full access to The Cannon Dispatch at cannondispatch.substack.com/subscribe

For today's Women Leading Validation spotlight conversation, Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Wendy Haines, PhD, DABT, ASQ CQA, Director of Toxicology & Technical Services at PharmEng TechnologyWendy has impacted human health laws at Environmental Protection Agency (EPA) starting in 1997, worked on the Genome Project between EPA and National Institute of Health (NIH), and later conducted her PhD at EPA. Wendy was a study director and functioned as single point of contact for all aspects of a study for both commercial clients and the government. She then moved from a contract laboratory setting to a consultant company providing toxicology, project management, and validation services to pharmaceutical and biotechnology manufacturers. Dr. Haines has conducted over 350 product toxicology safety risk assessments for contract manufacturers and owner companies and provides guidance on product testing, worker safety programs, cleaning validation, and extractable and leachable projects.Wendy's unique perspective, understanding of professional societies – how you can participate, volunteer and network with others to expand your knowledge.  *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer. This is a joint Podcast production of ProcellaRX and KENX

Dori Gonzalez-Acevedo Co-Founder & CEO of ProcellaRX welcomes Jacqueline Davidson, Owner of Davidson QA Consulting and Head of Regulatory Intelligence and Innovation at Sware, Inc to Software Quality Today.Download now to listen to Jackie's perspective on S.O.U.P, (Software of Unknown Providence) what is it and how can you leverage it within your organization. Innovation is driven by scientists; they test the limits of their ideas as quick as possible to see what's possible and vet out what's not – one way to do that as efficiently as possible is with the use Open-Source technology/software rather than having to build their own.  As an industry we need to be able to shift to use S.O.U.P. where possible in order test our hypotheses and potentially save critical time to market as a competitive advantage. This often comes by using open-source technology but how can we if we don't have ultimate control over that software? S.O.U.P may not be a term you may not be familiar our guest today clarifies, puts it into perspective and how it could be utilized in a heavily regulated industry such as life sciences when it's fit for purpose.  Sware LinkedInSware Website *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

On today's episode of Women Leading Validation, Dori Gonzalez-Acevedo, CEO of ProcellaRX interviews Katie Terry. A fellow Chief member, Katie is a life science executive bringing over 20 years of experience in drug development, quality, and manufacturing.  She holds a bachelor of science in biology from Utica University and a MBA from Simmons School of Management.  Katie has held leadership roles at Biogen, Alnylam, and most recently Acceleron, where she was the Vice President of Quality.  She has a passion for building global high performing teams, transforming early stage firms nearing commercialization, and promoting a compliance-centric culture.  Katie recently transitioned to consulting where she advises life science executives on topics such as quality management systems, manufacturing strategies, and commercial launch readiness. *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer. This is a joint Podcast production of ProcellaRX and KENX

Podcast第4回目は以下のようなことを話しています。* コミュニティ・ロイヤリティ* DigiDaigakuと無料のNFT* MoonbirdsとCC0ライセンス* 分散型IP、Story Protocol* 音楽（arpeggio）* ゲーム（Mud, 0xcurio）Twitterリンク* CoffeeTimes* consome※Disclaimer: このPodcastでは話されるいかなる内容も、投資助言、法律助言ではありません。 This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.bspeak.xyz

Podcast第3回目は以下のようなことを話しています。* StarkNetの方針、新しいCairo* StarkNetのEVM（カカロット）* zkRollup間のコンポーザビリティ* Enshrined Rollup* L2のエコシステム・競争* MEVの話* L2のシークエンサー* zkの界隈* L3Twitterリンク* CoffeeTimes* consome※Disclaimer: このPodcastでは話されるいかなる内容も、投資助言、法律助言ではありません。 This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.bspeak.xyz

For today's Women Leading Validation spotlight conversation, Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Connie Hetzler Global Head of Validation, Alcon Laboratories and Lisa Sykes-Winstead  Site Quality Head, Senior Director, ResilienceConnie and Lisa shared their insights into what's it means to be women in leading roles in validation, their day to day experience and why mentoring and sponsorship is important.  This was recorded live with Dori on Day 2 at KENX's GMP University August 2022.   *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer. This is a joint Podcast production of ProcellaRX and KENX

For today's Women Leading Validation spotlight conversation, Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Denise Dajles, Senior VP of R&D, Regulatory and Quality Denise Dajles, Senior VP of R&D, Regulatory and Quality  at Sientra located in Santa Barbara, California and fellow Chief Member.  Denise graciously shared her day, experience, and thoughts with Dori on Day 2 at KENX's GMP University August 2022.  Denise is a Biomedical Engineer with a Bachelor's and a Master's degree from Washington University in St. Louis, and is currently pursuing a Doctorate in Engineering Management from George Washington University. Denise has over 15 years of experience, both in industry and academia, leading new product development, global regulatory affairs, and quality management in medical devices. After working for companies such as Inamed, Allergan, and Prosein, Denise transitioned to Academia, where she led a Research Lab focused on brain computer interfaces, being the first women to lead a Research Lab in the Electrical Engineering department and oversaw over 10 different research projects. Ms. Dajles returned to corporate life after more than six years dedicated to research and teaching to lead the R&D department of Establishment Labs, an Aesthetics Medical Device company, successfully developing over eight different products, taking them from concept to market. Ms. Dajles currently serves as the Sr. VP of R&D, Regulatory, and Quality at Sientra, also an Aesthetics Medical Device Company, and is responsible for developing the innovation strategy, which includes managing the technology roadmap to address current and anticipated customer needs, leading the design, planning and implementation of the company's global regulatory strategy and quality system, as well as scouting and assessing new technologies and business development opportunities. Ms. Dajles is also a co-author of several publications in peer-reviewed journals and a book chapter and is a named inventor on a number of medical technologies.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a joint Podcast production of ProcellaRX and KENX 

This month's episode of Women Leading Validation, Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Avital Avitsur. Avital is the Co-Founder and Chief Business Officer at Validify, an innovative company helping regulated companies to automate the risk analysis and validation processes.  Avital is a CPA with experienced in mergers & acquisitions (M&A), financial accounting, securities regulation, transaction support and corporate finance. Strong sales professional with a master's degree focused on international business, trade, and tax law.Few years ago, Avital decided to pivot her career and use her vast knowledge in the Israeli hi-tech industry and started a partnership program in her former company. 3 years ago, a friend from her army service offered her to join "Validify" as a co-founder to bring her business and partnership experience, and since then she is a female entrepreneur that likes to share her journey with others to encourage other women to join the arena.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a joint Podcast production of ProcellaRX and KENX

Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Ann Vu, JD, RAC, currently  of Sr. Vice President, Quality, Regulatory and Clinical at ZimVie.  Ann brings more than 25 years of quality and regulatory experience in the medical device, pharmaceutical, nutritional and biologics sectors. Ann oversees quality and regulatory compliance across our global organization. Ann joined ZimVie from Zimmer Biomet, where she led Quality and Regulatory Affairs for Robotics and several other business units. She has also held progressive leadership roles with global companies, including Ethicon, Ortho Clinical Diagnostics, Bausch + Lomb, and Steris. Dori and Ann are fellow Chief members and are passionate about Women Leading Validation! *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions he shares are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer. This is a joint Podcast production of ProcellaRX and KENX

Project management always has and always will be a crucial function in any organization. In life sciences, that function is changing. Project Managers need to adapt to ensure their teams continue to deliver successful projects in the face of a shifting technology and methodology landscape, while still ensuring compliance. Join us this episode for a fantastic interview with Project Manager extraordinaire, and Founder and CEO of MustardSeed, Steve Curry!Steve Curry's LinkedInMustardSeed's LinkedInMustardSeed's WebsiteSteve Curry, PMP has a passion and calling to help lead projects, programs, teams, and businesses to tremendous success by increasing their maximum potential of operating efficiency through the utilization of program management best practices. He is equally passionate about communicating with clients when project risks and issues arise. It comes from Steve's extensive experience and background in managing projects and programs of all sizes and his experience in finance, sales, business analysis, and management. Steve has had the benefit of working in PMOs in four different industries. Having spent nearly 20 years in the field, he has dedicated himself to collecting, organizing, compiling, and implementing today's best PM practices. Today Steve leads MustardSeed as Founder and CEO. MustardSeed provides project management services to life science companies.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

A risk-based approach to Computerized System Validation has been around for over 20 years, so what's the hype about CSA? Join us in this episode as we are joined by our amazing guest, Dr. Bob McDowall, to explore this question.Bob McDowall is an analytical chemist with 50 years of experience including 15 years working in the pharmaceutical industry and 29 years as a consultant to the industry and suppliers to the industry. He has been involved with the validation of computerized systems for over 35 years and is the author of the second edition of a book on the validation of chromatography data systems published in 2017 and a book on data integrity for regulated laboratories in 2019.Bob is the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns.  One such column in September 2021 was entitled Does CSA Mean Complete Stupidity Assured? It is available online at: https://www.spectroscopyonline.com/view/does-csa-mean-complete-stupidity-assured-*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Welcome to the first episode of Women Leading Validation!  Dori Gonzalez-Acevedo, CEO of ProcellaRX and host of Women Leading Validation Podcast interviews Madhavi Ganesan.  Recorded Live from KENX CSA Hybrid Training May 11-12, 2022.  For the past 20 years, Madhavi has supported her pharma and medical device clients assess their current quality landscapes to develop successful Computer Systems Validation and Computer Software Assurance transformation strategies. This includes working with cross-functional teams to develop solutions implementing critical thinking methodologies and risk-based strategies to simplify overly complicated CSV programs to minimize non-value work, cost, and improve overall delivery. She is a dynamic leader that is passionate about supporting women leading validation! *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions he shares are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a joint Podcast production of ProcellaRX and KENX

THIS IS IT! The Finale episode of The Macaroni Rascals. Today we reminisce about all the good times we had with our little gang of Guidos and Guidettes. Lots of fights, lots of drama for our cast of characters. And a lot of time for us hosts of the show. We had fun doing this and we are looking forward to giving you MORE content that you DID NOT ASK FOR, down the road! Later peeps. DISCLAIMER: Due to the nature and mature audience rating of Jersey Shore as a show, the podcast hosts may use language and refer to topics throughout this series that may be considered crude, distasteful or offensive. Listener beware and please use discretion if children are present. DISCLAIMER: Podcast hosts are covering these characters as they are portrayed to us in their reality series. We understand that "reality" is a loosely used term and many of the Jersey Shore cast have gone on to be very accomplished and changed individuals. We are simply covering their characters as they develop within the time and space of their own series. Please keep this in mind as you listen and formulate your own ideas about them and their storylines. Thank you! --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app

In today's episode, we see some old faces. And we see some new ones get punched. A stalker is on the loose, but is there more than meets the eye? Find out on this episode! DISCLAIMER: Due to the nature and mature audience rating of Jersey Shore as a show, the podcast hosts may use language and refer to topics throughout this series that may be considered crude, distasteful or offensive. Listener beware and please use discretion if children are present. DISCLAIMER: Podcast hosts are covering these characters as they are portrayed to us in their reality series. We understand that "reality" is a loosely used term and many of the Jersey Shore cast have gone on to be very accomplished and changed individuals. We are simply covering their characters as they develop within the time and space of their own series. Please keep this in mind as you listen and formulate your own ideas about them and their storylines. Thank you! --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app

BLEAV IN BEARS is excited to welcome host of 'The Sick Podcast', NFL Network's Adam Rank to break down the biggest stories in the NFL, preview what the Bears will do in Free Agency, talk Fantasy Football and MORE! Adam's reaction to Aaron Rodgers returning to the Packers/ Russell Wilson to the Broncos/ Carson Wentz to the Commanders (6:19), What Eberflus will bring to the Bears defense (13:41) We preview Free Agency/Will the Bears take a big swing? (16:32), Fantasy Football! Will Justin Fields be a top-12 play? (26:29), Will Cole Kmet take a leap next season? (32:08) And we wrap up the pod debating; What is the Greatest Bears Offseason of All-Time? (35:14) And we discuss some of the most impactful 'Sliding Doors' moments in Bears history (46:05) DISCLAIMER: Podcast was recorded and finished LITERALLY 15 minutes before the Khalil Mack Trade News: Full Breakdown on that move coming soon!

In today's episode, we talk...at length. It's a Whopper of an episode. That might be an easter egg if you read this?? Buckle up folks, you're in for a ride. DISCLAIMER: Due to the nature and mature audience rating of Jersey Shore as a show, the podcast hosts may use language and refer to topics throughout this series that may be considered crude, distasteful or offensive. Listener beware and please use discretion if children are present.  DISCLAIMER: Podcast hosts are covering these characters as they are portrayed to us in their reality series. We understand that "reality" is a loosely used term and many of the Jersey Shore cast have gone on to be very accomplished and changed individuals. We are simply covering their characters as they develop within the time and space of their own series. Please keep this in mind as you listen and formulate your own ideas about them and their storylines. Thank you! --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app

In today's episode we talk food, fights and Fred Flintstone. Vinnie gets himself into a mini situation. Ronnie loses his flip flops. And what's that I hear? A grenade launcher firing off or could it be a hungry, hungry hippo? Someone teach Snookers how to duck, cause fists be flying...as usual. At the Jersey Shore, it's always CLOBBER'N TIME.  DISCLAIMER: Due to the nature and mature audience rating of Jersey Shore as a show, the podcast hosts may use language and refer to topics throughout this series that may be considered crude, distasteful or offensive. Listener beware and please use discretion if children are present. DISCLAIMER: Podcast hosts are covering these characters as they are portrayed to us in their reality series. We understand that "reality" is a loosely used term and many of the Jersey Shore cast have gone on to be very accomplished and changed individuals. We are simply covering their characters as they develop within the time and space of their own series. Please keep this in mind as you listen and formulate your own ideas about them and their storylines. Thank you! --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app

In today's episode, we do accents, talk about the stalker, find out about the nudie cove in Austin, TX and find out what it takes to turn friends into family DISCLAIMER: Due to the nature and mature audience rating of Jersey Shore as a show, the podcast hosts may use language and refer to topics throughout this series that may be considered crude, distasteful or offensive. Listener beware and please use discretion if children are present. DISCLAIMER: Podcast hosts are covering these characters as they are portrayed to us in their reality series. We understand that "reality" is a loosely used term and many of the Jersey Shore cast have gone on to be very accomplished and changed individuals. We are simply covering their characters as they develop within the time and space of their own series. Please keep this in mind as you listen and formulate your own ideas about them and their storylines. Thank you! --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app

**TW: This episode briefly covers a physical assault on a female.** In this episode, DoBro and Sis (aka Okie Dokie) are taking "heavy fire" as we learn exactly what a grenade is. We're introduced to Snookie's mama. And later, Snookie's face gets introduced to a fist, in a shocking and unfortunate twist of events. Do you get named dropped in this episode? Only if you wear jeans to sleep or know how to microblade eyebrows...  DISCLAIMER: Due to the nature and mature audience rating of Jersey Shore as a show, the podcast hosts may use language and refer to topics throughout this series that may be considered crude, distasteful or offensive. Listener beware and please use discretion if children are present.  DISCLAIMER: Podcast hosts are covering these characters as they are portrayed to us in their reality series. We understand that "reality" is a loosely used term and many of the Jersey Shore cast have gone on to be very accomplished and changed individuals. We are simply covering their characters as they develop within the time and space of their own series. Please keep this in mind as you listen and formulate your own ideas about them and their storylines. Thank you! --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app

Artificial Intelligence and Machine Learning are being used to great results in a variety of ways across numerous industries, but what does it mean for the Life Sciences industry? How can Life Sciences teams that want to stay on the cutting edge begin to practically incorporate AI/ML to drive better, more efficient results across their organizations?If you're looking for answers, you've come to the right place. Give this podcast a listen to hear subject matter expert, Eric Staib, share his incredibly insightful and valuable thoughts on the topic.*Disclaimer: Eric Staib participated in the podcast as an individual subject matter expert and contributor. The views and opinions he shares are not necessarily shared by his employer, Signant Health. Nor should any reference to specific products or services be interpreted as commercial endorsements by Signant Health.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

In today's episode, we see fake sickness sweep through the shore house, talk about rubbernecking and learn exactly why “You never fall in love at the Jersey Shore”. DISCLAIMER: Due to the nature and mature audience rating of Jersey Shore as a show, the podcast hosts may use language and refer to topics throughout this series that may be considered crude, distasteful or offensive. Listener beware and please use discretion if children are present. DISCLAIMER: Podcast hosts are covering these characters as they are portrayed to us in their reality series. We understand that "reality" is a loosely used term and many of the Jersey Shore cast have gone on to be very accomplished and changed individuals. We are simply covering their characters as they develop within the time and space of their own series. Please keep this in mind as you listen and formulate your own ideas about them and their storylines. Thank you! --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app

In this episode, we find out if Snookie decides to the leave the Shore house for good. Ron Ron Juice makes its first appearance. Vinny announces a debilitating infection and a "Doctor" tends to the wounded.  Show Recap:  DISCLAIMER: Due to the nature and mature audience rating of Jersey Shore as a show, the podcast hosts may use language and refer to topics throughout this series that may be considered crude, distasteful or offensive. Listener beware and please use discretion if children are present. DISCLAIMER: Podcast hosts are covering these characters as they are portrayed to us in their reality series. We understand that "reality" is a loosely used term and many of the Jersey Shore cast have gone on to be very accomplished and changed individuals. We are simply covering their characters as they develop within the time and space of their own series. Please keep this in mind as you listen and formulate your own ideas about them and their storylines. Thank you! --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app

In our first podcast episode, Christy & Steve talk about their personal history with the iconic show Jersey Shore, some headline news from the show's debut year of 2009, "Roncenzo" and more!   Show Recap: When eight soon to be roommates move into their summer house share, romance heats up between Sammy and Mike. Meanwhile, the guys invite three random girls to join them in the hot tub. DISCLAIMER: Due to the nature and mature audience rating of Jersey Shore as a show, the podcast hosts may use language and refer to topics throughout this series that may be considered crude, distasteful or offensive. Listener beware and please use discretion if the kids are around.  DISCLAIMER: Podcast hosts are covering these characters as they are portrayed to us in their reality show. We understand that "reality" is a loosely used term and many of the Jersey Shore cast have gone on to be very accomplished and changed individuals. We are simply covering their characters as they develop within the time and space of their show. Please keep this in mind as you listen and formulate your own ideas about them and their stories. Thank you! --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app

Dori welcomes long-time colleague and Sr. Manager of TCoE at Biogen, Ajay Pandey to the podcast. With extensive knowledge of application testing and software quality in Life Sciences, Ajay shares his insights on setting up a strategic Testing Center of Excellence framework, as well as the importance of incorporating risk-based testing.Ajay is a Senior IT professional with over 19 years of progressive experience in management and governance of Application Lifecycle Management/SDLC toolsets in large Medical Device and Bio-Pharmaceutical space as well as a Certified Project Management Professional (PMP).Give it a listen, and please don't forget to rate and subscribe wherever you get your podcasts.*Disclaimer*: Ajay has agreed to participate in the Software Quality Today podcast as an individual subject matter expert. The views and opinions he shares are his own and are not necessarily shared by his employer, Biogen. Nor should any reference to specific tools or products be interpreted as commercial endorsements by Biogen.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Dori is able to grab some time with Micro Focus SAP expert, Don Jackson.  From automating SAP, to process management, to streamlining maintenance of components and assets, Don has a variety of insights he shares based on his years of experience. In addition, he is able to share some extremely valuable tools that Micro Focus brings to the world of SAP testing/maintenance which help their clients in the realm of SAP and beyond.General SAP testing questions? SolMan questions? S4HANA questions? Dori and Don cover it all, so tune it!A bit more about Don: Don Jackson is an IT professional with 20+ years of experience delivering testing and quality initiatives.  Mr. Jackson is recognized in the IT Quality/Testing industry as a thought leader and has spoken at multiple conferences, webinars, seminars, and publications. Don is currently the Chief Technologist for ADM at Micro Focus.Disclaimer: Don is appearing as an individual subject matter expert, and the views and opinions he shares are not necessarily shared by his employer, Micro Focus.As always, please don't forget to rate and subscribe wherever you get your podcasts.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

In this episode, Dori sits down with fellow CSV and CSA guru Ken Shitamoto for some outdoor, morning coffee on the final day of the KENX Computer Systems Validation and Software assurance conference.Together, they share their insights not only on CSV/CSA, but the overall state of software quality in Life Sciences and what we as industry professionals can do to collectively raise the bar as we move into 2022.As mentioned in the episode outro, they discuss some recent comments from Cisco Vicenty where he discusses the current status of the CSA draft guidance. To further clarify, I wanted to direct you to the link below at about the 8:30 mark of the publicly available MDIC presentation recorded on December 8th in which Cisco elaborates on where the draft guidance currently is in the process.View presentation here.Thanks for tuning in and don't forget to subscribe wherever you get your podcasts to be notified whenever new episodes are released.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Join us from a beach in San Diego, California, at the KENX Computer Systems Validation and Software Assurance conference. In this episode, Dori is joined by industry colleague and subject matter expert, Rohit Tyagi, President and CEO of Sagax Team.They discuss some of the presentations and topics that have been covered at the KENX conference this year, as well as general thoughts, challenges, and successes that folks are currently experiencing related to CSV modernization and CSA adoption strategies.Please listen to get all their insights, but please don't forget to rate and subscribe wherever you get your podcasts. Also, please reach out to Rohit and Sagax team via the LinkedIn profiles and URLs below:Sagax Team Website: https://www.sagaxteam.com/Rohit's LinkedIn: https://www.linkedin.com/in/247results/?miniProfileUrn=urn%3Ali%3Afs_miniProfile%3AACoAAACDuxYBeNHQ7o6FuO-IhNvldXFdFjGNUig *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

In this quick episode following our attendance at the ISPE Annual Meeting and Expo, I sat down with our host, Dori Gonzalez-Acevedo, to do a bit of a post-conference wrap-up episode. We discuss some of the highlights of the conference relating to software quality, common themes we heard, issues that our industry needs to address, and the overall takeaways from the event.Tune in to hear Dori's thoughts and don't forget to rate and subscribe where you get your podcasts!*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Join Dori as she interviews Lydia Castiallas, the Southeast Sales Leader for Enterprise Accounts at Micro Focus - but fear not, dear listeners! This is not a sales conversation or a sales pitch. Lydia brings a wealth of experience to the table and some valuable insights on the current state of IT, as well as important considerations for staying ahead in an ever-changing landscape.Later in the conversation, they spend some time discussing the diversity and inclusion groups that Lydia is involved with at Micro Focus and elsewhere - a subject and pursuit that Dori shares a passion for.This was a great episode, so give it a listen and don't forget to subscribe!*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Eric Toburen, Co-Founder of Tx3 Services, joins Dori in this episode to discuss what it took to build Tx3, the mentality that we bring to our clients, and the excitement of being considered a leading provider in the Life Sciences industry. That's not all, though! Give it a listen to hear the full conversation.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

In this episode, Dori is joined by longtime friend and colleague, Mike Fannon, the CEO of BioIT Solutions. With Mike's extensive career in the Biotech space, ranging from manufacturing through SQA, they discuss the evolution of the Biotech industry, the trends of today, the impacts of COVID, and how Mike and the BioIT Solutions team are enabling "a new better" for the Biotech world. Jump in and give it a listen!*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Before we get too deep into the run of this show, we thought it would be good to do an episode where you fine folks at home can get to know the host of Software Quality Today, Dori Gonzalez-Acevedo. I know why you can and should trust Dori as a true subject matter expert in our world of regulated software, and after this episode I'm sure you will too!*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

In this episode, Dori interviews Ed Hein, Manager of Digital Validation and Verification at Lifescan. With years of experience in the medical device field, Ed shares his thoughts on the challenges and best practices for testing software as a medical device, as well as some insights on the current state and future of the industry.Take a listen to get the scoop!*Ed has agreed to participate in this podcast as an individual subject matter expert, and his views and opinions do not necessarily reflect those of his employer, Lifescan. Nor should any mention of products or services be interpreted as endorsements by Lifescan.*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

In today's episode, Dori interviews longtime friend, colleague, and Tx3 Co-Founder/CEO, Jason Tepfenhardt. From his start back in the labs all the way through forming Tx3, they'll discuss everything in between. Through providing an honest view of himself, Tx3, and lessons he's learned along the way, Jason shares his ideas on what he wants for not just the Tx3 team, but also for our clients, and the Life Sciences industry as a whole.We were even graced by a brief, but special guest appearance by Jason's dog, Newman. Did Newman have any valuable insights on the state of the industry to share? Well, probably not, but tune in to the episode to find out for yourself!Visit us at https://www.tx3services.com/ *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

It's never been more apparent that change is happening all around us. How we and our organizations choose to act and adapt to those changes will set us apart from those around us. Join us for an exploratory conversation as we dive into this theme with thought leaders in IT and QA at some of the top Life Sciences organizations in the industry. In this great thought leadership panel discussion, our host,  Dori Gonzalez-Acevedo, VP of Strategic Solutions at Tx3 Services, will Interview: Alyce Deegan – (former) Director of Computer System Validation, Seattle Genetics Pritam Khade – Director of Quality Assurance, AbbVie (formerly Allergan) Raechelle Raimondo – Executive Director – Global Systems Assurance, AbbVie (formerly Allergan)Wendy Zambrana – Director of IT Quality, Biogen *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX