Episodes
162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid T…
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, inc...
161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in M…
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, an...
160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!
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 regulator...
159 - Centralized, Decentralized & Federated Quality Models, McKinsey…
In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across various organizational structures. Through their engaging discussion, they highl...
158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Proces…
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 produ...
157 - Design Inputs that Don't Suck, Risk Control Measures and Proble…
In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked topic of design inputs in product development. Chuck highlights how poor d...
156 - Combination Product Governance, Big Pharma to Medical Device St…
On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc. On this episode, Laxman, highlights the differences in regulatory oversight and risk management bet...
155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led In…
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 combina...
154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinic…
On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs,...
153 - USP 382, Elastomeric Component Functional Suitability, Delivery…
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 38...
152 - Global Medical Device Podcast Interview: Behind the Combinate P…
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 Po...
151 - Primary Packaging/Container Closure Change Guidance, Post-Appro…
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses: 00:00 Introduction 02:29 Unders...
150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, G…
On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses: 00:00 Welcome to Episode 150! 03:00 Challenges and Innovations in Ocular Drug Delivery 09:30 Un...
149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, …
On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode David discusses: 01:01 Recap of the Last Episode 01:23 Understanding the Fr...
148 - Standards Applicability Assessments, Atomic Requirements, Docum…
On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of standards to medical devices and co...
147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, …
On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through: David Grosse-Wentrup PhD is a Research Director at Design Science , a global human facto...
146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption,…
On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final ste...
Regulatory Policy, Advocacy, Legislation, Combination Product Regulat…
On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmoniza...
144 - Auto-Injectors, Pen Injectors, Challenges in Product Developmen…
On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery. David and I discuss: 00:00 Introduction and Guest Overview 00:04 David DeSalvo's Career Journey 02:...
143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan…
On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs and Biological Products Guidance for Industry. I...
142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Qualit…
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 01:53 Material Qualification Discussion Begins 02:23 Material Qualification in Drugs vs. Devices 04:00 Q...
141 - Lessons from the Life and Legacy of Quality Guru H. James Harri…
On this episode of the Combinate Podcast, I go over 6 lessons from the life and x of H. James Harrington. Dr. H James Harrington has a decorated career with 40 years at IBM, 10 years at Ernst & Young, and has held multiple ...
140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software,…
On this episode, I was joined by Christian Espinosa CEO of Blue Goat Cyber. On this episode, Chrsitian walks through: 00:00 Introduction and Guest Overview 00:20 Christian Espinosa's Journey: From Air Force to Cybersecurity ...
139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combina…
This is a solo episode. On this episode, Subhi goes through: 01:51 Draft FDA Guidance - Platform Technology Designation Program for Drug Development Guidance for Industry 13:03 EMA Guidance - Questions & Answers for applicant...