Podcasts about Aami

Episode is based on a talk Subhi Saadeh gave at CPHI. In this episode, Subhi Saadeh breaks down the three levels where true harmonization must happen for drug-device products to succeed:-Global regulatory alignment-Effective sponsor-CXO collaboration-Cross-functional teamwork between drug and device stakeholders inside companiesSubhi covers why regulatory misalignments across countries create uncertainty, how disconnected sponsor-CXO relationships lead to delays and inefficiencies, and how internal friction between pharma and device functions can stall programs even when the science is sound.Timestamps:00:00 – Introduction: The Reality of Drug-Device Combination Products00:39 – Identifying the Core Issues in Combination Product Development01:38 – What Are Drug-Device Combination Products?02:05 – Common Types of Combination Products05:00 – Market Growth & Regulatory Landscape07:26 – Challenges and Silos That Slow Progress10:01 – Practical Strategies for Harmonization and Collaboration14:56 – Final Thoughts: Why Harmony Beats SamenessSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Ever wondered who's really behind the regulations you follow in pharma and medical devices? In this episode of Let's ComBinate, Subhi Saadeh breaks down the five categories of organizations that influence how we develop, test, and release products:Regulatory Authorities (like FDA, EMA, PMDA)Harmonization Bodies (like ICH, IMDRF, and PIC/S)Standards Organizations (ISO, ASTM, etc.)Pharmacopoeias (USP, JP, Ph. Eur.)Industry Groups (like PDA, MDIC, PhRMA, and more)Subhi dives into how each type contributes to the rules, expectations, and gray areas that define your work — and how to figure out which ones really matter when you're reviewing SOPs, guidance docs, and regulatory submissions.00:00 – Intro01:23 – Regulatory Bodies04:03 – Harmonization Organizations10:01 – Standards Organizations12:07 – Pharmacopoeias13:59 – Industry Groups16:11 – Wrap-up and TakeawaysSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, Subhi Saadeh—an ISO 13485 certified lead auditor, CQA, and CQE—dives into the evolving role of auditing in the medical device and pharmaceutical industries. He reflects on his journey to becoming a Certified Quality Auditor and asks a timely question: in the age of AI, will audits—and auditors—still matter? Subhi outlines what separates good auditors from great ones, shares lessons from his own audit experiences, and breaks down how AI might streamline parts of the audit process. But he makes a clear case: while AI can assist, it can't replace the critical thinking, real-time risk judgment, and systems awareness that human auditors bring. The episode wraps with practical advice on how to embrace AI as a tool—without losing the edge that only people have.00:00 Introduction to Auditing and Certification00:43 My Auditing Journey and Experience02:40 The Importance of Technique in Auditing03:26 Real-World Auditing Insights04:59 The Value of Certification07:16 Key Qualities of a Great Auditor10:48 The Role of AI in Auditing12:18 Why AI Won't Replace Human Auditors15:26 Conclusion and Future OutlookSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

What's the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?In this episode of Let's Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical device design. Learn how these two approaches tackle product realization, why they're not interchangeable, and how both are essential when building safe, effective, and compliant combination products.Whether you work in drug development, medical devices, or the space in between, this episode will help you:-Understand the regulatory foundations of QbD (ICH Q8) and design controls (FDA 21 CFR 820.30)-Learn the core tools and deliverables (like CQAs, QTPP, design verification & validation, and risk assessments)-See how each system addresses user needs, therapeutic effects, and process control-Apply both systems effectively in combination product developmentTimestamps:00:00 – Intro: Why Compare QbD and Design Controls?01:31 – Philosophical Differences: Process vs. Product Control03:10 – Practical Examples: Drugs vs. Devices05:13 – Origins and Frameworks: ICH Q8 and Design Controls Regulation06:46 – Deep Dive: What Are Design Controls? (Inputs, Outputs, DHF, V&V, Transfer)11:51 – What Is Quality by Design (QbD)? (QTPP, CQAs, Design Space, DOE)15:39 – Final Takeaways: How to Use Both in Combination ProductsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.------------------------ICH Q8, Q9, Q10, and Q12ISO 14971 Risk ManagementDifferences between usability engineering and clinical trialsThe role of control strategies and process monitoring in pharmaRelevant for:Regulatory affairs professionalsQuality engineers in pharma and medtechDrug/device development teamsAnyone preparing for combination product submissions or audits

In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly aimed at bioengineering students and early-career professionals. The tips include: publishing early to build visibility, understanding how industry regulations and processes work, developing interdisciplinary skills, and finding mentors for guidance. Subhi emphasizes the importance of learning for its own sake and seeking out diverse experiences to enhance one's career prospects in the highly regulated field of bioengineering.00:00 Introduction and Purpose of the Episode00:36 Tip 1: Start Publishing Early04:26 Tip 2: Learn How Industry Really Works06:14 Tip 3: Build Skills Across Disciplines09:00 Tip 4: Find Mentors and Network12:08 Conclusion and RecapSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Documentation Hierarchy and Best Practices in Quality Systems with Aaron SnyderIn this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in quality systems, which serves as the backbone of compliance. Key topics include the hierarchy of regulations, document management best practices, the intricacies of quality manuals, and the critical distinctions between SOPs and work instructions. Additionally, they explore the interconnectedness of document control and training, emphasizing the importance of defined roles and responsibilities within organizations. Listeners are provided with insights into establishing and maintaining effective documentation systems while ensuring adherence to regulatory requirements.00:00 Introduction and Guest Introduction00:37 The Importance of Documentation in Quality Systems01:30 Hierarchy and Structure of Documentation02:44 Standard Operating Procedures (SOPs) vs. Work Instructions11:22 Document Control and Change Management15:52 Roles and Responsibilities in Quality Systems18:20 RACI Matrix and Its Importance20:47 Common Issues in Documentation and Training25:25 Conclusion and Where to Find More InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, host Subhi Saadeh welcomes back Skip Creveling, a global expert in program management and Six Sigma methodologies.Skip shares his extensive experience helping Fortune 500 companies optimize design processes, reduce risks, and drive innovation—especially in highly regulated industries like medical devices, pharmaceuticals, and aerospace.The discussion explores Skip's career transition from Eastman Kodak to the medical device sector, the importance of structured program management, phase gate processes, and the balance between going fast and ensuring thorough planning.Skip also delves into the differences between simple and complex projects and the necessity of having tailored project management templates for various project scales.The episode concludes with insights into how to manage risks effectively through tools like project and portfolio FMEAs, and the importance of data-driven decision-making in project execution.Timestamps:00:00 – Introduction and Guest Welcome00:19 – Skip's Background and Experience01:10 – Transition to Medical Devices and Pharma03:35 – Program and Project Management Insights06:03 – Phases and Gates in Product Development08:59 – Challenges and Strategies in Project Management10:51 – Examples of Project Management in Action13:28 – Importance of Planning and Risk Management18:10 – Templates and Tools for Effective Project Management29:49 – Final Thoughts and Contact InformationAbout the Host:Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.For questions, inquiries, or suggestions, please visit letscombinate.com or connect on the show's LinkedIn page.

West End State Coach Darren Reeves reviews AAMI State Game by Zac Milbank

Understanding GXPs: Essential Good Practices for Bioengineering ProfessionalsIn this episode of Let's Combinate, host Subhi Saadeh, a seasoned bioengineer with ten years of experience in the pharma and medical device industries, provides an in-depth exploration of good practice guidelines (GXPs). Subhi covers various GXPs including GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), and GDP (Good Distribution Practice), explaining their roles, regulations, and importance in ensuring the safety, efficacy, and quality of medical devices and pharmaceuticals. He discusses how these frameworks integrate to form a comprehensive approach that governs the lifecycle of medical products from preclinical research to post-market surveillance. Additionally, Subhi delves into GAMP (Good Automated Manufacturing Practice) and GVP (Good Pharmacovigilance Practice), emphasizing their significance in maintaining data integrity and patient safety. This extended episode aims to provide early professionals with a robust understanding of these critical regulatory standards and their real-world applications in industry.00:00 Introduction to GXP02:22 Understanding GMP: Good Manufacturing Practice09:21 Exploring GLP: Good Laboratory Practices17:57 Diving into GCP: Good Clinical Practices24:00 Ensuring Quality with GDP: Good Distribution Practices29:32 Overview of GVP and GAMP33:48 Conclusion and Final ThoughtsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

GDP Script/ Top Stories for April 5th Publish Date: April 5th PRE-ROLL: MONSTER JAM From the BG AD Group Studio Welcome to the Gwinnett Daily Post Podcast. Today is Saturday, April 5th and Happy Birthday to Abba I’m Peyton Spurlock and here are your top stories presented by Gwinnett KIA Mall of Georgia. New Events Join Fan Favorites On Duluth's 2025 Events Schedule Third annual GGC summit focuses on achieving success Jordan Davis Coming To Gwinnett's Gas South Arena Plus, the Stripers report with manager Kanekoa Texeira All of this and more is coming up on the Gwinnett Daily Post podcast, and if you are looking for community news, we encourage you to listen daily and subscribe! Break 1: 07.14.22 KIA MOG STORY 1: New Events Join Fan Favorites On Duluth's 2025 Events Schedule Duluth is spicing up its 2025 event lineup with new weeknight attractions and returning favorites. New events include *Wednesday Flavors on Main* (food trucks), *Parsons Thursday Nights Out* (music, trivia, movies), *Rock the Block Fridays* (live music), and *Dogtoberfest* (pet-friendly fun). Fan favorites like *Howl on the Green* (Halloween), *Duluth Derby Day*, *Viva Las Duluth*, and the *Summer Stage Concert* are also back. The Duluth Farmers & Artisan Market will run March-May and September-November, with the Children’s Entrepreneur Market held twice, on May 4 and November 2. STORY 2: Third annual GGC summit focuses on achieving success Georgia Gwinnett College’s third annual African American Male Initiative (AAMI) Summit inspired over 130 students from GGC, UNG, and Gordon State College to turn dreams into success stories. With the theme “He Ain’t Heavy, He’s My Brother! Dream Big,” the event emphasized self-worth, teamwork, and goal-setting. Speakers like Gustavious Maddox shared how AAMI shaped their college experiences and inspired initiatives like mentoring programs. Students like Coréon Johnson, GGC’s incoming Student Government president, and peer mentor Dallas Hogan highlighted AAMI’s role in fostering growth, leadership, and a supportive brotherhood to help participants achieve their aspirations. STORY 3: Jordan Davis Coming To Gwinnett's Gas South Arena Jordan Davis is bringing his 2025 *Ain’t Enough Road Tour* to Gwinnett’s Gas South Arena on Oct. 23, joined by Mitchell Tenpenny and Vincent Mason. Tickets go on general sale April 4 at 10 a.m. via JordanDavisOfficial.com. The CMA and ACM award-winning artist announced the tour with a humorous video featuring Peyton Manning and Jim Nantz. Davis also released his new single, “Bar None,” from his upcoming album, following hits like “I Ain’t Sayin’” and his platinum-selling *Bluebird Days* album, which produced four No. 1 singles. We have opportunities for sponsors to get great engagement on these shows. Call 770.874.3200 for more info. We’ll be right back Break 2: MONSTER JAM STRIPERS INTERVIEW Break 3: MONSTER JAM STORY 6: Snellville Police Remind Drivers April is Distracted Driving Awareness Month As Distracted Driving Awareness Month begins, the Snellville Police Department is urging drivers to stay focused and avoid distractions behind the wheel. With distracted driving causing over 3,000 fatalities annually in the U.S., the rise of smartphones and in-car tech has increased risks. Key tips include putting phones away, setting up GPS or playlists before driving, and being a role model for safe habits. Snellville Police are hosting events, campaigns, and proactive traffic enforcement throughout April to combat distracted driving and promote road safety. STORY 7: First Resilient Gwinnett Summit Tackles Mental Health The inaugural *Becoming a Resilient Gwinnett Summit* brought 200 mental health professionals and community leaders together in Duluth to focus on mental health awareness and resilience. Featuring workshops, expert speakers, and a panel on workplace resilience, the event emphasized tools for building resilience in families, workplaces, and communities. Key highlights included Tra Battle’s message on overcoming trauma and Emily Valle’s focus on addressing childhood adversity. The Gwinnett Coalition introduced the *Resilient Gwinnett Toolkit*, an online resource for trauma-informed practices. The summit marked a significant step toward systemic change and fostering mental wellbeing across Gwinnett County. We’ll have closing comments after this Break 4: Ingles Markets 10 Signoff – Thanks again for hanging out with us on today’s Gwinnett Daily Post Podcast. If you enjoy these shows, we encourage you to check out our other offerings, like the Cherokee Tribune Ledger podcast, the Marietta Daily Journal, or the Community Podcast for Rockdale Newton and Morgan Counties. Read more about all our stories and get other great content at www.gwinnettdailypost.com Did you know over 50% of Americans listen to podcasts weekly? Giving you important news about our community and telling great stories are what we do. Make sure you join us for our next episode and be sure to share this podcast on social media with your friends and family. Add us to your Alexa Flash Briefing or your Google Home Briefing and be sure to like, follow, and subscribe wherever you get your podcasts. Produced by the BG Podcast Network Show Sponsors: www.ingles-markets.com www.kiamallofga.com www.monsterjam.com/en-us/ #NewsPodcast #CurrentEvents #TopHeadlines #BreakingNews #PodcastDiscussion #PodcastNews #InDepthAnalysis #NewsAnalysis #PodcastTrending #WorldNews #LocalNews #GlobalNews #PodcastInsights #NewsBrief #PodcastUpdate #NewsRoundup #WeeklyNews #DailyNews #PodcastInterviews #HotTopics #PodcastOpinions #InvestigativeJournalism #BehindTheHeadlines #PodcastMedia #NewsStories #PodcastReports #JournalismMatters #PodcastPerspectives #NewsCommentary #PodcastListeners #NewsPodcastCommunity #NewsSource #PodcastCuration #WorldAffairs #PodcastUpdates #AudioNews #PodcastJournalism #EmergingStories #NewsFlash #PodcastConversations See omnystudio.com/listener for privacy information.

In this episode of Let's Combinate, Subhi Saadeh shares personal insights and seven crucial lessons on finding the right mentors in the pharmaceutical and medical devices sectors. Subhi emphasizes the transformative impact mentors have had on his life and career, breaking down the types of mentors one can have, such as teachers, sponsors, and peer mentors. He provides practical advice on lowering your expectations, focusing on value and repetition, being mentor-able, and leveraging non-traditional forms of mentorship, like books and advanced tools. Subbi concludes that mentorship is about being open, curious, and willing to learn from various sources.00:00 Introduction: The Power of Mentorship02:06 Lesson 1: Different Types of Mentors05:04 Lesson 2: Lower Your Bar for Mentors07:51 Lesson 3: Focus on Value and Repetition09:37 Lesson 4: Be Mentor-able11:37 Lesson 5: Look Sideways, Not Just Up12:58 Lesson 6: Don't Wait for a Formal Title15:01 Lesson 7: Mentors Can Be Dead16:41 Conclusion: Recap and Final ThoughtsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.

This episode covers maintaining water quality for infection control in hemodialysis. Topics include AAMI standards, monitoring water quality for safety, training staff on infection control for water systems, and addressing water treatment system issues.

This episode covers maintaining water quality for infection control in hemodialysis. Topics include AAMI standards, monitoring water quality for safety, training staff on infection control for water systems, and addressing water treatment system issues.

Discover how ampoule(ampule) drug delivery systems could revolutionize the pharmaceutical industry in this eye-opening video. Learn about the potential impact of this innovative technology on drug administration and patient care.In this episode of 'Let's Combinate Drugs and Devices,' host Subhi Saadeh is joined by Eric Suglalski, Founder and CTO of Archimedic, to discuss the often-overlooked role of ampules in drug delivery. Eric highlights the stability and contamination resistance benefits of ampules, despite the industry's shift towards vials and pre-filled syringes. He elaborates on the time and cost factors that make transitioning to pre-filled syringes challenging for pharmaceutical companies. The discussion also covers Eric's work on the Ampule Filled Syringe (AFS) system, which aims to combine the usability of pre-filled syringes with the stability of ampules. They delve into the historical context of ampules, global usage patterns, and the hurdles faced in implementing ampule-based technologies. Eric invites interested pharma companies to explore potential collaborations with Ampulous.00:00 Introduction and Guest Welcome00:17 The Overlooked Potential of Ampoules02:11 Challenges with Vials and Prefilled Syringes05:01 The Cost and Time Barrier to Prefilled Syringes08:29 Introducing Ampulous: A New Solution10:36 Technical Details of Ampule Filled Syringes14:39 Historical Context and Global Use of Ampoules16:38 Addressing Concerns and Resistance18:01 Human Factors and Usability19:44 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, host Subhi Saadeh, a seasoned quality professional, delves into the concept of 'everyone owns quality' and explains why this notion is flawed. Subhi recalls his eye-opening experience with Joanna Gallant's article on quality ownership and discusses the importance of clear accountability within organizations. The episode emphasizes that while all employees play a role in quality, true ownership lies with top management. Subhi also highlights regulatory frameworks like ISO 13485 and 21 CFR 820, noting how they mandate management's responsibility for quality systems. The discussion extends to real-world examples, including the Ranbaxy scandal, to illustrate the dire consequences of poor quality management. The episode concludes with a call to shift the mindset from 'everyone owns quality' to 'leadership owns quality.' 00:00 Introduction to Quality Ownership04:10 Regulatory Frameworks and Quality Management05:14 The Flaws in 'Everyone Owns Quality'06:45 Case Study: Ranbaxy Laboratories08:49 The Importance of a Strong Quality CulturePrevious Episodes:Joanna Gallant: https://www.letscombinate.com/076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant/Katherine Eban: https://www.letscombinate.com/115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pros-with-nyt-be/Links: ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdfISO13485: https://www.iso.org/standard/59752.html21CFR820: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-B/section-820.20BBC Article: https://www.bbc.com/news/world-asia-india-22520953Bottle of Lies: https://www.amazon.com/Bottle-Lies-Inside-Story-Generic/dp/0062338781Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.

In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action). They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory contexts. Aaron explains how U.S. regulations describe deviations on the pharma side and non-conforming products on the MedTech side, and how these are handled differently under respective quality systems. The conversation also touches on topics like root cause analysis, verification of effectiveness, and the importance of management support in making CAPA systems effective. Aaron highlights the value of continuous improvement and debunks common misconceptions about CAPA in both industries.00:00 Introduction and Guest Introduction00:33 Understanding CAPA in Pharma and MedTech01:08 Regulatory Differences and Their Implications03:12 Event Handling and Investigation Processes08:13 CAPA System Effectiveness13:57 Quality System Approaches in Pharma and MedTech26:22 Root Cause Analysis and Continuous Improvement30:43 Conclusion and Contact InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

The Ball Boys Mitch & Luke discuss the fall out from the AAMI community series practice matches and talk about who saw their stock rise, and who saw their stocks fall!Join our Patreon - www.patreon.com/ballboysJoin us for season 3 by making sure you are subscribed to wherever you listen to podcasts and on Youtube!Sign up for Keeper today to get your AFL Fantasy Draft League sorted!https://keeperfantasy.com/Follow the boys on Twitter!Mitch - @ballboysfantasyLuke - @lukerogo17#aflfantasy #supercoach #afl AFL Fantasy,Fantasy AFL,AFL,AFL Dreamteam,Supercoach,AFL Fantasy 2025,Supercoach 2025,AFL Dreamteam 2025,DT Talk,AFL Fantasy must have players,afl fantasy pods,how to play afl fantasy,The Traders,how to win afl fantasy,afl fantasy advice,afl fantasy podcast,afl podcast,fantasy sports,fantasy football,afl fantasy football,fantasy football 2025,the ball boys,ball boys,ball boys fantasy,mitch caseyAdvertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy

Roy, Calvin and Warnie chat through the fourth quarter of the Hawthorn v Western Bulldogs AAMI Community Series game from University of Tasmania Stadium, Launceston on Thursday 27 February 2025. Play now at http://fantasy.afl.com.au. Click here for more content from The Traders. Like AFL Fantasy on Facebook. Follow @AFLFantasy on Instagram. Follow @AFLFantasy on Twitter.See omnystudio.com/listener for privacy information.

Roy, Calvin and Warnie chat through the first quarter of the Hawthorn v Western Bulldogs AAMI Community Series game from University of Tasmania Stadium, Launceston on Thursday 27 February 2025. Play now at http://fantasy.afl.com.au. Click here for more content from The Traders. Like AFL Fantasy on Facebook. Follow @AFLFantasy on Instagram. Follow @AFLFantasy on Twitter.See omnystudio.com/listener for privacy information.

Roy, Calvin and Warnie chat through the second quarter of the Hawthorn v Western Bulldogs AAMI Community Series game from University of Tasmania Stadium, Launceston on Thursday 27 February 2025. Play now at http://fantasy.afl.com.au. Click here for more content from The Traders. Like AFL Fantasy on Facebook. Follow @AFLFantasy on Instagram. Follow @AFLFantasy on Twitter.See omnystudio.com/listener for privacy information.

Roy, Calvin and Warnie chat through the third quarter of the Hawthorn v Western Bulldogs AAMI Community Series game from University of Tasmania Stadium, Launceston on Thursday 27 February 2025. Play now at http://fantasy.afl.com.au. Click here for more content from The Traders. Like AFL Fantasy on Facebook. Follow @AFLFantasy on Instagram. Follow @AFLFantasy on Twitter.See omnystudio.com/listener for privacy information.

In this episode of Let's Combinate Drugs and Devices, host Subhi Siddhey welcomes Eric Sugalski, founder and CTO of Archimedic. Eric shares insights into the complexities of working as a CDMO, emphasizing the importance of recognizing whether a sponsor company needs overflow capacity or specialized expertise. They discuss common pitfalls, such as companies getting in their own way by misaligning their needs with their outsourcing strategy and the detrimental effects of premature concept lock. Eric highlights the value of giving design firms creative space, the importance of early user research, and the impact of timing and market readiness on project success. He also elaborates on the benefits of open-source quality management systems and hands-on market research to bridge the gap between engineers and users. Together, they explore how to set up projects for success through balanced, well-researched approaches.00:00 Introduction and Guest Welcome00:13 Challenges in Outsourcing for Pharma and Med Device Companies01:04 Importance of Expertise in Outsourcing03:27 Effective Collaboration with CDMOs04:41 Concept Development and Design Requirements05:38 Balancing Innovation and Practicality07:48 Commercialization and Product Development09:57 Understanding User Needs in Design20:47 Advice for Aspiring Engineers25:15 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Ben Locwin discusses the science, quality, and future of GLP-1 receptor agonists, revolutionary drugs used in diabetes and obesity treatment. The episode explores the history and development of GLP-1s, their commercial viability, manufacturing challenges, and regulatory landscapes. Ben dives into the mechanisms of GLP-1s, including their influence on appetite, blood sugar, and gastrointestinal effects. They also touch on the capacity issues in production, the impact of compounding, and the sustainability concerns associated with injector pens. The conversation provides an in-depth look at the pharmaceutical industry's response to the surge in GLP-1 demand, highlighting the broader implications for patient care and market trends. 00:00 Introduction to GLP Receptor Agonists 00:46 Guest Introduction: Ben Locwin 01:48 Historical Context of GLP-1 Development 05:54 Mechanisms and Effects of GLP-1 09:51 Market Impact and Manufacturing Challenges 11:16 Regulatory and Advertising Considerations 17:44 Sustainability and Injector Pen Issues 19:40 Risk Management and Future Directions 23:31 Conclusion Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, host Subhi Saadeh interviews Shelly Amster, a trailblazer in reproductive health with over 45 years of experience. Shelly shares her journey from being one of the first IVF lab directors in the U.S. to her role as an advisor at 3 Daughters. They discuss the early days of IVF, overcoming career-related insecurities, and the challenges and advancements in fertility treatments. Shelly also talks about her experience in managing technical conferences and offers advice for early-career professionals. The conversation covers innovative technologies in women's health, particularly in IUD development and surgical advancements. 00:00 Welcome to Let's Combinate 00:13 Pioneering in Reproductive Health 00:42 Early Challenges and Opportunities 02:10 Breaking Barriers in IVF 04:52 Career Reflections and Lessons 06:40 Conference Planning Insights 13:37 Overcoming Shyness and Networking 19:11 Retirement and Career Advice 26:21 Innovations in Women's Health 30:26 Future Technologies and Closing Thoughts Shelley Amster is a trailblazer in reproductive medicine with over 45 years of experience, including being one of the first IVF lab directors in the United States. Currently an advisor at Three Daughters, she has dedicated her career to advancing fertility treatments, IUD development, and surgical innovations in women's health. Shelley is also a seasoned conference organizer and mentor, sharing invaluable insights with early-career professionals in the field. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

We all find the cost of insurance too high, but have you ever thought to actually fight against big hikes to your premium? A growing number of Australians are trying just that, with limited success. Today, national consumer affairs reporter, Michael Atkin, on why insurance costs continue to surge and how Australians are trying to force the insurance giants to justify the hikes.  Michael Atkin explains that insurance premiums have jumped 11% in the past year, following even higher increases in previous years. He shares stories from frustrated home owners like Mark Stacey and Warren Vant, who have seen their premiums skyrocket. The industry justifies these hikes, citing increased severe weather and inflation. Michael Atkin says while some consumers have had success challenging their insurers through the Australian Financial Complaints Authority, many others have not been as fortunate.Featured: Michael Atkin, national consumer affairs reporterKey Topics:Insurance premium hikesAustralian Financial Complaints Authority (AFCA)Natural disasters and insuranceInflation and building costs

In this episode of Let's Combinate, host Subhi Sadeh welcomes regulatory expert Doug Mead. Doug, who brings extensive experience in regulatory affairs for medical devices and combination products, discusses the significant role of the 'Drugs at FDA' database in navigating submission strategies. They explore how AI is being used to search through this database efficiently and reveal both the benefits and limitations of AI in regulatory processes. Doug also shares insights into the evolution of FDA's review processes, the importance of validation, and the practical application of AI in regulatory work. 00:00 Welcome and Introduction 00:07 Meet Doug Mead: Regulatory Expert 00:58 Understanding the Drugs at FDA Database 01:25 Navigating Review Memos and Regulatory Strategies 04:18 Challenges and Limitations of the FDA Database 07:23 Advanced Search Techniques and AI Integration 10:58 Developing a Specialized AI Search Tool 14:57 Practical Applications and Client Benefits 33:22 Conclusion and Contact Information Douglass(Doug) Mead is Founder of CP Pathways. He's a highly experienced combination products regulatory expert with more than 40 years of experience in large and small pharma and medical device companies. He has a diverse background in regulatory affairs for drugs and devices, including their design and testing, risk analysis, human factors testing, stability testing, and clinical trial real use patient handling assessments. www.cppathways.com Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page. Artificial intelligence in Pharma, AI Pharma, AI Medical Devices, Medical Device AI

In this episode of 'Let's Combinate,' host Subhi Saadeh delves into the challenges and complexities of working with prefilled syringes in regulatory, quality, and product development settings. Subhi, who has worked on vaccines, biologics, and small molecules in prefilled syringe systems He explores what makes a prefilled syringe a combination product and explains the varying regulatory requirements across different regions, including the US, EU, China, and Japan. The episode emphasizes the importance of understanding these differences to ensure success in product development and market approval. Saadeh also invites viewers to engage and provide feedback in the comments section.00:00 Introduction to Prefilled Syringes01:54 Understanding Combination Products02:32 Regulatory Frameworks for Prefilled Syringes04:59 Global Regulatory Perspectives06:10 Key Takeaways and ConclusionSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.Pre-filled Syringes: Are They Really Combination Products?Are They Really Combination Products?,are they really combination products?,Is a PFS a Combination Product,https://youtu.be/eq_IEsBflQE,https://youtu.be/eq_iesbflqe,They Really Combination Products,they really combination products,Are They Really Combination,are they really combination,They Really Combination,they really combination,steph curry,Pre-filled Syringes Are They Really Combination,filled Syringes Are They Really Combination,Pre-filled Syringes Are They Really

By viewing ISO 13485 through the lens of interconnected Plan-Do-Check-Act (PDCA) cycles, Subhi offers a fresh perspective that simplifies the implementation of this quality management standard. He explains the structure of ISO 13485, highlighting how each clause aligns with PDCA, and provides practical examples of applying this cycle to different processes within the standard. Subhi emphasizes that ISO 13485 is more than a rule book; it's a guide for continuous improvement and real-world application in the medical device field. 00:00 Introduction to Game-Changing ISO 13485 Insight 01:24 Understanding ISO 13485 as a Guide 02:11 ISO 13485 Structure and Clauses 03:56 Plan, Do, Check, Act (PDCA) Cycle Explained 05:44 Applying PDCA to ISO 13485 Clauses 07:33 Real-World Application and Continuous Improvement 09:10 Conclusion and Call to Action Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode, Subhi Saadeh, a seasoned professional in the pharma and medical device industry, shares his insights on whether choosing bioengineering is the right career path. Drawing from his 10+ years of experience, Subhi discusses the differences between bioengineering and biomedical engineering, the pros and cons of studying bioengineering, and how to approach this field in 2025. He emphasizes the importance of technical skills, networking, and adapting to a competitive, fast-paced, and evolving industry. Additionally, Subhi provides practical advice for high school and early college students considering this major, highlighting key skills to develop and strategies to stand out in the field. 00:00 Is Bioengineering the Right Path for You? 00:58 Understanding Bioengineering vs. Biomedical Engineering 03:06 My Personal Journey into Bioengineering 06:00 The Future of Bioengineering Careers 07:48 Pros and Cons of Studying Bioengineering 12:32 How to Succeed in Bioengineering in 2025 15:32 Final Thoughts and Advice Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, host Subhi Saadeh discusses the significance of audits as a key appraisal activity and draws parallels with personal self-assessment inspired by Peter Drucker's book, 'Managing Oneself.' He emphasizes the value of understanding one's learning style and values in personal development. Subhi delves into the different types of audits, including internal, second-party, and third-party audits, and explains their unique purposes and importance. The episode highlights the relevance of audits in maintaining quality and compliance in the pharma and medical device industries, while also offering best practices for effective audit management. Subhi invites listeners to use audits as a tool for growth, safety, and success. 00:00 Introduction 00:12 'Managing Oneself' by Peter Drucker 00:55 Key Quotes from the Book 03:33 Connecting Audits to Self-Improvement 04:37 Understanding Audits 06:55 Types of Audits 10:27 Best Practices in Auditing 12:03 Conclusion and Final Thoughts Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, host Subhi Saadeh dives into the world of digital transformation in healthcare with Dr. Timothy Aungst, a visionary pharmacist and digital health expert. Dr. Aungst breaks down digital therapeutics, smart drug delivery systems, and wearable technology. He elaborates on the nuances of digitalization, digital transformation, and how these concepts are reshaping the pharmaceutical and healthcare industries. The discussion also touches on the evolving role of pharmacists in a tech-driven healthcare landscape, the impact of AI, and the regulatory challenges in adopting new technologies. 00:00 Introduction to Digital Apothecary with Dr. Timothy Ongst 01:00 Understanding Digital Transformation in Healthcare 03:11 The Evolution of Digital Health and Its Impact 08:23 Future of Healthcare: Expectations and Innovations 13:03 Challenges and Strategies in Pharma's Digital Transformation 20:46 The Role of Digital Tools in Drug Delivery and Adherence 21:19 Challenges of Digital Integration in Healthcare 22:14 Pharmacist's Perspective on Drug Line Therapy 24:04 Clinical and Payer Considerations 25:33 Digital Transformation in Medication Efficacy 30:36 Regulatory Challenges and Bias in Healthcare 36:38 The Role of AI in Digital Health 39:48 Closing Thoughts and Future Outlook Dr. Timothy Aungst is a leading expert in digital health and pharmacy, widely recognized for his work in advancing digital therapeutics, medication adherence technologies, and the integration of health apps into clinical practice. As the voice behind The Digital Apothecary, Dr. Aungst bridges the gap between emerging digital health innovations and the pharmaceutical landscape. His insights provide valuable guidance for healthcare professionals navigating the rapidly evolving intersection of technology and medicine. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In episode 122, host Jon Wood speaks with members of the KiiP team about sterile barrier wrap, more commonly known as “blue wrap.” Karina Engels from Owens & Minor/Halyard, Amanda Benedict from AAMI, Tanya Magana of Ecolab, Jennifer Zeck from Solventum, and Sterile Processing technician Tiffany Reece discuss the importance of consistent standards for wrap. They review what to do when encountering multilayer or potentially compromised wrap and explain how KiiP works to investigate concerns and connect users, experts and manufacturers to identify solutions. Earn CE Now

In this episode, Subhi Saadeh delves into the specifics of USP chapters 788 and 790, which focus on the testing and acceptance criteria for sub-visible and visible particles in injectable drug products. He explains the importance of these standards in preventing health risks such as embolisms and allergic reactions. The episode outlines the methods used for testing, including light obscuration and microscopic particle count tests, as well as the required visual inspections for visible particles. Subhi also discusses the differences in scope between USP and ISO standards and emphasizes the critical role of operator training and clean handling practices in ensuring product safety. 00:00 Introduction to Today's Topic: Particles 00:48 Understanding USP and Its Role 02:52 Diving into USP 788: Sub-Visible Particles 05:40 Testing Methods for Sub-Visible Particles 07:00 Acceptance Criteria for Sub-Visible Particles 08:53 Exploring USP 790: Visible Particles 11:12 Inspection Techniques and Practical Considerations 12:50 Conclusion and Wrap-Up Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode, Subhi delves into 'Quality is Free' by Philip Crosby, a seminal book in quality management. Highlighting its personal significance, the host discusses the core concept that quality, when properly managed, incurs no extra cost, aligning with prevention rather than fixing issues. The episode dissects five erroneous beliefs about quality, including the idea that quality equates to luxury, that it is intangible and immeasurable, and that quality issues stem from workers or are confined to the quality department. Emphasizing a holistic and preventative approach, the discussion reflects on different quality philosophies and the importance of leadership alignment. The episode concludes by encouraging listeners to read the book themselves for a deeper understanding of quality management principles. 00:00 Introduction to 'Quality is Free' 00:24 The Impact of 'Quality is Free' 01:30 Key Concepts: What We Think We Know is All Wrong 02:23 5 Erroneous Beliefs About Quality 06:26 Measuring Quality: Cost and Prevention 09:09 Quality "Responsibility" in Different Departments 15:02 Aligning Leadership and Quality Management 17:05 Conclusion Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, host Subhi Saadeh explores the essential frameworks of risk management in medical devices and pharmaceuticals: ISO 14971 and ICH Q9. He discusses the origins, key elements, similarities, and differences of these standards and guidelines, explaining their application in the development and manufacturing of combination products. Saadeh also highlights the definitions of risk, historical developments, and updates in these frameworks, particularly ICH Q9's recent refinements on managing subjectivity and the formality of risk assessments. The episode compares the structured approach of ISO 14971, focused on patient safety through the entire lifecycle of medical devices, with the broader risk management scope of ICH Q9, which encompasses various elements within the pharmaceutical process. Saadeh provides insights into specialized tools, the concept of state-of-the-art, and the importance of verification of implementation and effectiveness in risk management plans. Listeners from regulatory, quality, product development, and risk management fields will gain a comprehensive understanding of balancing these crucial frameworks for combination products. 00:00 Introduction to Risk Management 00:21 Understanding ISO 14971 and ICH Q9 01:02 Key Elements and Differences 01:35 Deep Dive into ISO 14971 05:08 Deep Dive into ICH Q9 08:53 Comparing Risk Management Tools 14:21 Combination Products and Risk Management 18:34 State-of-the-Art and Residual Risks 21:35 Verification and Effectiveness 22:50 Conclusion and Final Thoughts Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.

In this episode of *Let's Combinate*, Subhi delves into the critical distinctions between drug tech transfer and device design transfer, especially pertinent to combination products. Sue comprehensively outlines the regulatory frameworks governing each process—ICH Q10 for drug transfer and ISO 13485 for device design transfer. The episode discusses key elements like analytical method transfer and process validation for drugs, and the DHF and risk management in device design. Subhi looks into the differing complexities, regulatory submissions, and validation requirements for both processes. The episode concludes with commercializing combination products, emphasizing project management, regulatory submissions, and post-market surveillance. 00:00 Introduction to Combination Products 00:55 Understanding Drug Tech Transfer 04:04 Exploring Device Design Transfer 08:49 Key Differences Between Drug and Device Transfers 14:30 Commercialization of Combination Products 17:54 Conclusion and Final Thoughts Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.

In this episode, host Subhi reflects on three years of podcasting, drawing analogies to strength training and discussing the incremental progress achieved. The episode highlights the importance of consistency in podcast production, inspired by Robert Greene's 'Mastery,' and outlines plans for the show's future evolution. 00:00 Welcome and Podcast Journey 00:39 Strength Training Analogy 02:10 Reflecting on Three Years 04:11 Significant Life Update 05:46 Lessons Learned and Trusting Others 07:37 Podcasting Process and Scheduling 10:34 The Challenges of Editing 11:21 Finding the Right Tools 12:11 Promotion and Growth 12:56 Consistency and Sustainability 13:07 Starting a Podcast: Advice and Reflections 15:52 The Future of the Show 20:12 Engaging with Listeners 21:12 Final Thoughts and Farewell Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.

Russ and Freddie talk about launching a fashion brand, yuppies making a comeback, AAMI's Grand Final ad, the Telstra effect, how Halloween gets to Australia, ‘nice' social media and advice for Dyson's foray into headphones.  Get in touch with Russ & Freddie Instagram: www.instagram.com/goodone.creative/ LinkedIn: www.linkedin.com/in/russelhowcroft/See omnystudio.com/listener for privacy information.

Russ and Freddie talk about launching a fashion brand, yuppies making a comeback, AAMI's Grand Final ad, the Telstra effect, how Halloween gets to Australia, ‘nice' social media and advice for Dyson's foray into headphones.  Get in touch with Russ & Freddie Instagram: www.instagram.com/goodone.creative/ LinkedIn: www.linkedin.com/in/russelhowcroft/See omnystudio.com/listener for privacy information.

Episode 122: FTC Non-Compete Rules on Hold: What Should Employers Do? 2024 saw the release of AAMI TIR99 for the reprocessing of probes & dilators. But many facilities are not aware of this new document and the recommendations that can help your department make informed decisions on these complex devices. As the co-chair for the AAMI working group that wrote this document, Garland-Rhea Grisby is uniquely qualified to introduce us to the wonderful world of TIR99! Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie discusses the definitions, scope, and expectations of combination product manufacturers, addressing the FDA's inspection types, regulatory requirements, and expectations. Laurie also highlights common misconceptions, especially among contract manufacturers (CMOs) and the importance of proper audit and supplier management practices. Laurie shares insights and practical advice for ensuring compliance, emphasizing the gaps between drug and device regulations and how to effectively bridge them. Chapters: 00:56 Understanding FDA Compliance Programs 02:33 Types of FDA Inspections 03:04 Mock Audits and Process Validation 03:45 Combination Product Manufacturer Definition 04:38 Inspection Guides and Compliance 06:47 Supplier Controls and Responsibilities 09:20 Challenges in Mock Pre-Approval Inspections 16:32 Supplier Management and Quality Agreements 24:19 Contract Manufacturers and Design Control 25:03 Conclusion Laurie Auerbach is an industry consultant with over 20 years of experience in quality and regulatory compliance, serving in management and consulting roles for startup to major global manufacturers in the medical device, in vitro diagnostic, and combination product industries. Laurie conducts internal and supplier audits and mock pre-approval and post-approval inspections for compliance with ISO 13485, ISO 14971, §820, and §4, and EU MDD, IVDD, and EU MDR. She also conducts training for biopharmaceutical sponsors and device platform manufacturers on combination product regulatory requirements, including focused training on design control, risk management, CAPA, supplier controls, and inspection readiness. Laurie serves as Vice Chair of the ISPE Combination Products Community of Practice and is an active member of PDA, AAMI, RAPS, TOPRA, and DIA.

2024 saw the release of AAMI TIR99 for the reprocessing of probes & dilators.  But many facilities are not aware of this new document and the recommendations that can help your department make informed decisions on these complex devices.  As the co-chair for the AAMI working group that wrote this document, Garland-Rhea Grisby is uniquely qualified to introduce us to the wonderful world of TIR99! 

This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380). In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and Definitions 13:46 Challenges and Misconceptions in the Industry 20:47 Evolution of Regulations: QMSR and Part 4 22:05 Exploring Unique Podcast Episodes 25:56 The Pyramid of Regulations 30:40 The Role of Coaching and Mentorship 32:59 Trends in Combination Products 35:23 Recommended Books and Final Thoughts 37:04 Encouragement for Lifelong Learning Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market

We have the privilege of welcoming back Janet E. Stout, Ph.D., President of Special Pathogens Technology and the founder of Special Pathogens Laboratory, A Pace Laboratory. Dr. Stout has academic affiliations with the School of Public Health and Swanson School of Engineering at the University of Pittsburgh. A self-described "Legionellologist", Dr. Stout's more than 30 years of research has defined the epidemiology, microbiology and prevention approaches for controlling Legionella growth in building water systems. In our most recent interview, Dr. Janet Stout shared what was new with Legionella standards, what state health departments are doing to combat Legionella, and she answers your burning question of “Are Legionella cases truly on the rise” with data and statistics. This is a Legionella episode you cannot afford to miss, so let's scale up our Legionella knowledge with Dr. Stout. Also, don't forget to check out our free Legionella Resources page where we have listed all of the articles, standards, and tools mentioned in this interview. What Is New with Legionella Standards? How Does It Impact the Water Treatment Industry? Dr. Stout highlights several key updates: Association for the Advancement of Medical Instrumentation (AAMI) TIR34:2023 Published in Fall 2023, TIR34 focuses on water quality for reprocessing medical devices. Dr. Stout emphasizes, "The problem is infection. The solution is the quality of the water." "There are clear chemical and microbial parameters, and these healthcare facilities need your assistance, water professionals," Dr. Stout encourages. ANSI/AAMI ST108:2023 This new standard, “Water for the processing of medical devices,” emphasizes the critical role of monitoring water quality to prevent microbial proliferation. ST108 is a significant step forward for patient safety. “I see so many positive indications of progress and prevention, and that's good for everyone,” shares Dr. Stout. General Services Administration (GSA) Order PBS 1000.7A Effective in 2024, this order mandates comprehensive water testing across federal buildings to ensure health and safety. It includes stringent testing protocols for contaminants like Legionella. Compliance requires professionals to hold certifications such as ASSE 12080 or be certified industrial hygienists (CIH). Dr. Stout remarks, "It's such a big deal that you have to be ASSE 12080 certified to service government buildings now, I'm really impressed by GSA." American Water Works Association (AWWA) Guidance Set to be updated in 2024 or 2025, the new standard will replace AWWA C651-C652 and will likely be titled “Disinfecting Potable Water.” This new guidance will provide updated protocols for disinfecting water-storage facilities, so be on the lookout for this new one. ANSI/ASHRAE Standard 514:2023 This standard focuses on risk management for building water systems, covering physical, chemical, and microbial hazards. It provides comprehensive guidelines for designing, building, maintaining, and operating water systems to protect building occupants. Challenge to the Listener: Educate Yourself: Familiarize yourself with the latest standards, including TIR34, ST108, GSA Order PBS 1000.7A, and ANSI/ASHRAE Standard 514. Engage with Clients: Reach out to healthcare facilities and federal buildings to offer your expertise in water management and help them navigate the new requirements. Stay Informed: Keep an eye on updates from organizations like AAMI, ASHRAE, GSA, and AWWA to stay ahead of industry changes. What's Going on in Ohio? Will Other States Follow Ohio? Ohio's Proactive Approach Dr. Janet Stout praises Ohio's innovative approach to managing Legionella risks. Unlike most areas where Legionella water management is voluntary, Ohio has taken a significant step by mandating it through hospital licensure codes. This mandate requires hospitals to have a water management plan and to test for Legionella, making compliance a condition for maintaining their licenses. The new regulation, scheduled to take effect in October 2024, aims to enhance infection control and manage the risk of waterborne pathogens, particularly Legionella. High Incidence of Legionnaires Disease Ohio's proactive stance is partly driven by its high incidence of Legionnaires disease. The state, along with Maryland, Pennsylvania, and New York, consistently reports high numbers of cases. Ohio's health department has noted a significant increase in cases from 2022 to 2023. This alarming trend highlights the urgent need for effective water management and testing protocols. The Ohio Regulation Specifies Detailed Requirements for Hospitals: Each hospital must conduct Legionella testing within the first twelve months. Two validation tests must be performed, no fewer than four months apart and no more than six months apart. The regulation includes explicit language to ensure rigorous water management and Legionella testing. The Future for Other States Dr. Stout is hopeful that other states will follow Ohio's example. She mentions ongoing legislative efforts in states like New Jersey and Pennsylvania, although the process is slow. Ohio's innovative and mandatory approach to Legionella water management sets a precedent that could influence other states. Dr. Stout's optimism reflects a broader movement towards more stringent and proactive water management practices across the country. As more states recognize the importance of these measures, we can expect a gradual but significant shift towards better management of Legionella and other waterborne pathogens. Are Legionella Cases Truly on the Rise? "Legionella is on the rise," Dr. Stout shares. "It's not increasing just because we are doing more testing." She also points to changing weather patterns as a contributing factor. "There's a global shift with Legionnaires' disease cases extending from summer into fall. The season is getting longer, and things are staying warmer longer." This observation highlights the need for a deeper understanding of how environmental factors and public health practices influence Legionella prevalence. We hope you found these insights from Dr. Janet Stout valuable. Legionella management is a critical aspect of industrial water treatment, and staying informed and proactive is key to ensuring the safety and health of building occupants. As always, we encourage you to continue learning, sharing, and growing within our community. Thank you for being a dedicated member of the Scaling UP! H2O community and for celebrating Legionella Awareness Month with us. Together, we can make a significant impact in the fight against Legionnaires' disease. Timestamps 01:00 - Upcoming Events for Water Treatment Professionals 06:00 - Interview with Janet E. Stout, Ph.D. is President of Special Pathogens Technology and the founder of Special Pathogens Laboratory, A Pace Laboratory 01:14:20 - Drop by Drop with James McDonald Quotes “It is happy Legionella Awareness Month because we are making progress.” - Dr. Janet Stout “I give Ohio a round of applause for doing the right thing!” - Dr. Janet Stout “You don't know if your efforts are working unless you test for it.”- Dr. Janet Stout “This is unacceptable: Legionnaires' disease remains a very high mortality infection. 25-30% of hospitalized patients who get legionella from the hospital die.” - Dr. Janet Stout “I see so many good indications of progress and prevention.” - Dr. Janet Stout “We need to make progress on mandatory testing because it's the only way to understand risk. We want to mitigate the risk.” - Dr. Janet Stout Connect with Janet E. Stout, Ph.D. Phone: 412.281.5335 Email: jstout@specialpathogenslab.com  Website: www.specialpathogenslab.com ST108, Utility Water (UWK) Kit LinkedIn: in/janet-e-stout-ph-d-32607612 company/special-pathogens-laboratory Drop By Drop with James In today's episode, I have a challenge for you.  The challenge is…update your LinkedIn profile.  Do it right now.  If you're driving, do it when you next stop.  The days of LinkedIn being just a resume are long gone.  Today, it's your calling card, your networking tool, and a learning tool.  Check out your name. Did you accidentally flip your name, so your last name comes before your first?  If you did, fix it now.  Is the name listed the one you actually go by?  If you go by a nickname, either put it in parenthesis or replace your formal name with it.  What does the headline right below your name say?  You get 3 seconds to catch someone's attention.  Does this little headline phrase under your name really say what you do and who you are?  What about your picture?  Do you look like the person people in your network would actually meet in person or are you dressed in a tuxedo or bridesmaid gown from the last wedding you were in?  I doubt many of us are doing our jobs in tuxedos and gowns.  Does your picture look unprofessional in other ways, as well?  The first things people see when looking at your LinkedIn calling card, as I call it, is your name, face, and headline.  Ensuring these three items are correct is the first place to start.  Then you can move on to experience, education (if applicable), etc. 2024 Events for Water Professionals Check out our Scaling UP! H2O Events Calendar where we've listed every event Water Treaters should be aware of by clicking HERE.  

Thursday Footy & Friends previews are here! The boys preview each match for the round of 14, discuss the GOAT Hawk from 2000-2030 (including a special phone call from Xav Ellis), plus recount their Maccas McSmart Moments from the weekend gone by. This episode of Footy & Friends is brought to you by AAMI. The AAMI Clangers for Good competition is back in 2024 & AAMI want to help community clubs bounce back from a recent clanger or challenge. AAMI are donating $10 for every Clanger recorded this AFL Premiership season with 8 community clubs in with a chance to win up to $15k! Tell AAMI in 100 words or less how they can help your club bounce back from a recent challenge. Enter now at aami.com.au/clangersforgood. T&C's apply. SEND IN YOUR QUESTIONS TO: mailbag@dylandfriends.com Contact Email - mailbag@dylandfriends.com Instagram - @dylbuckley @dylandfriends Youtube - @clubbysports Facebook - dylandfriends Tiktok - @dylandfriends Dyl & Friends is produced by Darcy Parkinson Video and audio production by Producey. ILY xx

On this week's edition of the Beyond Clean Expert Series On-The-Go, tune in for the conversation entitled, "AAMI TIR34: Critical Water Management" with our Water Quality Expert™, Jeffrey Paquet. To hear more from this expert, follow us on Facebook and LinkedIn, or subscribe to the Beyond Clean mailing list by visiting: http://www.beyondcleanmedia.com Do you know a #SterileProcessing expert who you'd love to hear from on our series? Or do you have a question for one of our current experts? Contact us at any time via email at: info@beyondclean.net Until next time, keep fighting dirty! #BeyondClean #ExpertSeries #Podcast