Let's Combinate - Drugs + Devices
Episodes
237 - ICH Q10: The Pharmaceutical Quality System
06 May 2026
Contributed by Lukas
his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key d...
236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences
29 Apr 2026
Contributed by Lukas
ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood.In this video, I break down what Quality Risk Management (...
235 - ICH Q8: How Pharmaceutical Development Actually Works
22 Apr 2026
Contributed by Lukas
This episode continues the ICH Quality Series with an overview of ICH Q8 (Pharmaceutical Development), focusing on what it is, how it’s structured, ...
234 - ICH Q7: The GMP Framework for API Manufacturing
15 Apr 2026
Contributed by Lukas
In this episode of Let’s Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturi...
233 - Most Teams Misunderstand Specifications | ICH Q6
08 Apr 2026
Contributed by Lukas
ICH Q6 Explained: Specifications, Control Strategy, and What’s Changing in Q6(R1)In this episode of Let’s ComBinate, Subhi continues the ICH Q-ser...
232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk
01 Apr 2026
Contributed by Lukas
Subhi Saadeh interviews Lucas Pianegonda, founder of Grad and a plastics expert in medical technology, on how medtech companies actually choose materi...
231 - Audit Findings Explained: Nonconformity vs Observation (CQA)
25 Mar 2026
Contributed by Lukas
This is a lesson out of my ASQ CQA course with Andy Robertson, on how to write and classify audit findings.Access the full CQA course here: https://cq...
230 - How Pharma Misses Critical Market Signals with Joe Luminiello
23 Mar 2026
Contributed by Lukas
In this episode of Let’s ComBinate, Subhi Saadeh sits down with Joseph Luminiello, CEO and Co-Founder of RCG Intel, to break down how competitive in...
229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products
11 Mar 2026
Contributed by Lukas
In this episode of Let’s Combinate, Subhi Saadeh speaks with Jen Riter about analytical method validation for drug device combination products. The ...
228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently
04 Mar 2026
Contributed by Lukas
Continuing the ICH Q series with ICH Q5. This episode explains why Q5 exists, how to read it, and what it means for combination products. Q5 addresses...
227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics
24 Feb 2026
Contributed by Lukas
Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using p...
226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification
18 Feb 2026
Contributed by Lukas
In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical...
226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions
11 Feb 2026
Contributed by Lukas
In this episode of the ICH Q series, Subhi Saadeh covers ICH Q4, which focuses on pharmacopeial harmonization. He explains why ICH Q4 exists, the prob...
225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes
04 Feb 2026
Contributed by Lukas
In this episode of Let’s ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are i...
224 - ICH Q2 Explained: What Analytical Validation Really Requires
28 Jan 2026
Contributed by Lukas
In this episode of Let’s Combinate, host Subhi Saadeh breaks down the ICH Q2 guideline with a practical focus on analytical procedure validation. Th...
223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations
21 Jan 2026
Contributed by Lukas
In this episode of Let’s Combinate: Drugs and Devices, host Subhi Saadeh breaks down the 2025 draft update to the ICH Q1 guideline and explains what...
222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series
14 Jan 2026
Contributed by Lukas
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh continues the Combinating with ICH series by breaking down how the Internatio...
221 - What Is ICH and Why It Matters
07 Jan 2026
Contributed by Lukas
In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh kicks off a new series focused on the International Council for Harmonisation (ICH...
220 - Managing Oneself, Reflections and a New Series on ICH
31 Dec 2025
Contributed by Lukas
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on re...
219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness
24 Dec 2025
Contributed by Lukas
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh is joined by Ben Locwin to break down what’s changing in FDA pre-approval a...
218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)
17 Dec 2025
Contributed by Lukas
In this short episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh breaks down ICH Q13 and what “continuous manufacturing” actually means. ...
5 Fixable Problems Holding Back Drug–Device Programs
10 Dec 2025
Contributed by Lukas
In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh addresses five significant quality issues in the combination product space....
216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke
03 Dec 2025
Contributed by Lukas
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a ...
215 - Why Aren’t Technical People Leading Drug-Device Audits?
26 Nov 2025
Contributed by Lukas
In this episode of Let’s Combinate, Subhi Saadeh breaks down why more engineers in pharma, medical devices, and combination products should seriousl...
214 - The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More)
19 Nov 2025
Contributed by Lukas
In this episode of Let's Combinate: Drugs + Devices host Subhi Saadeh welcomes back Andy Robertson, founder of CQE Academy. Andy shares his transf...
213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site
12 Nov 2025
Contributed by Lukas
What happens when you go all in on a generic injectable that no one else wants, and it turns into a one hundred million dollar product in the first ye...
212 - What 6 of the World’s Biggest Companies Taught Him About Combination Products
05 Nov 2025
Contributed by Lukas
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional wh...
211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer
30 Oct 2025
Contributed by Lukas
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh welcomes Mark Kramer, the founding director of FDA’s Office of Combination ...
210 - The 8 Roles You MUST Understand in Pharma & MedTech
22 Oct 2025
Contributed by Lukas
I get a lot of questions from students and early-career professionals about what different industry roles actually mean: what does a Quality Engineer ...
210 - How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield
15 Oct 2025
Contributed by Lukas
As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, B...
209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos
08 Oct 2025
Contributed by Lukas
In this episode, I talk with Monika Andraos of Dunamis Compliance about how organizations can navigate group think and approach data integrity the rig...
208 - How Drugs Are Designed, Targets, Phenotypes, and Structure Based Design
01 Oct 2025
Contributed by Lukas
In this episode, Jesse Gordon-Blake, PhD, delves into the intricacies of medicinal chemistry, particularly focusing on drug discovery for ALS (amyotro...
207 - What 99.999% Reliability Really Means
24 Sep 2025
Contributed by Lukas
In this episode, Subhi Saadeh sits down with Alan Stevens, CAPT, to break down the concept of five nines (99.999% reliability) in medical devices. The...
206 - Will AI Decide Your Next Drug/Device Approval?
17 Sep 2025
Contributed by Lukas
Artificial Intelligence is moving fast but how do you regulate it in industries where precision and risk management are everything?In this episode of ...
205 - Why Less Than 20% of Companies Have Started Quality 4.0
11 Sep 2025
Contributed by Lukas
Nearly two-thirds of companies believe Quality 4.0 will transform their operations in the next five years yet fewer than 20% have started, and most ha...
204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle
03 Sep 2025
Contributed by Lukas
In this episode of Let’s ComBinate: Drugs + Devices, we welcome back Susan Neadle, author of The Combination Products Handbook. Susan explores the p...
203 - Drug Delivery, Platforms, IP Battles, Supply Chain Risks with Jim Collins
27 Aug 2025
Contributed by Lukas
In this episode of Let’s Combinate, Subhi Saadeh sits down with Jim Collins, a leader in drug delivery with over 30 years of experience at Eli Lilly...
202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin
20 Aug 2025
Contributed by Lukas
In this episode of Let's Combinate, host Subhi Saadeh is joined by long-time friend and Senior Technical Program Manager Joey Frechin, who brings a we...
201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0
13 Aug 2025
Contributed by Lukas
In this episode of Let’s ComBinate, Subhi Saadeh sits down with Jeff Gensler, a quality and regulatory leader with 30+ years in MedTech, pharma, and...
200 - MedTech and Pharma After 200 Episodes…..
06 Aug 2025
Contributed by Lukas
In this milestone episode, I reflect on what it’s taken to record, edit, and release 200 episodes focused on medical devices, pharma, and combinatio...
199 - How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall
30 Jul 2025
Contributed by Lukas
In this episode of Let’s Combinate, host Subhi Saadeh is joined by Mark Burchnall, Director of Engineering at PSN Labs, to break down the evolving r...
198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed
23 Jul 2025
Contributed by Lukas
In this episode of Let's Combinate, host Subhi Saadeh highlights five critical aspects of the FDA's new Quality Management System Regulation (...
197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong
16 Jul 2025
Contributed by Lukas
In this episode of Let’s Combinate, host Subhi Saadeh breaks down the critical role of quality agreements in the pharmaceutical and medical device i...
Combi Crumbs: Clinical Trials 101 – From Safety to Strategy
12 Jul 2025
Contributed by Lukas
From Episode 195 with Archana SahIn this clip of the larger interview with Archana Sah, she covers the critical phases and elements of clinical trials...
196 - How to Win Your First 90 Days in Pharma and MedTech
09 Jul 2025
Contributed by Lukas
In this episode, I go over 8 lessons to maximize your first 90 days in Life Sciences. These include understanding the impact of their roles, adopting ...
195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah
02 Jul 2025
Contributed by Lukas
In this episode of Let's Combinate, Archana shares her insights on the critical factors involved in designing clinical trials, from phase one safety p...
194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer
25 Jun 2025
Contributed by Lukas
In this episode I sit down with Mike Denzer, a mechanical engineer, inventor, and trusted leader in the combination product space. We talk about the p...
193 - Bioengineering Grads: Here’s What Recruiters Actually Want to See in 2025
18 Jun 2025
Contributed by Lukas
In this episode of Let’s Combinate, host Subhi Saadeh is joined by Kirk Petyo, Managing Partner at Talent Factory Medical and founder of Talent Fact...
192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)
11 Jun 2025
Contributed by Lukas
If you’ve ever wondered what a combination product is—or how to explain it—this video breaks it down clearly and simply. This is a non-technical...
191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity
04 Jun 2025
Contributed by Lukas
You’ve heard it before: If it’s not documented, it didn’t happen. But in life sciences, documentation isn’t just a formality—it’s the foun...
190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong
28 May 2025
Contributed by Lukas
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 ...
189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?
21 May 2025
Contributed by Lukas
Ever wondered who’s really behind the regulations you follow in pharma and medical devices? In this episode of Let’s ComBinate, Subhi Saadeh break...
188 – Certified Quality Auditor(CQA) and Audits in the Future
14 May 2025
Contributed by Lukas
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 t...
187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)
07 May 2025
Contributed by Lukas
What’s the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination...
186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech
30 Apr 2025
Contributed by Lukas
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 boo...
185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder
23 Apr 2025
Contributed by Lukas
In this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultan...
184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained
16 Apr 2025
Contributed by Lukas
In this episode of Let's Combinate, host Subhi Saadeh welcomes back Skip Creveling, a global expert in program management and Six Sigma methodolog...
183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products
09 Apr 2025
Contributed by Lukas
Understanding GXPs: Essential Good Practices for Bioengineering ProfessionalsIn this episode of Let's Combinate, host Subhi Saadeh, a seasoned bioengi...
182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma
02 Apr 2025
Contributed by Lukas
In this episode of Let's Combinate, Subhi Saadeh shares personal insights and seven crucial lessons on finding the right mentors in the pharmaceutical...
181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?
26 Mar 2025
Contributed by Lukas
Discover how ampoule(ampule) drug delivery systems could revolutionize the pharmaceutical industry in this eye-opening video. Learn about the potentia...
180 - MIT Leadership Expert Reveals Management Secrets for Scientists!
19 Mar 2025
Contributed by Lukas
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on re...
179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing
12 Mar 2025
Contributed by Lukas
In this episode of Let's Combinate, host Subhi Saadeh, a seasoned quality professional, delves into the concept of 'everyone owns quality' and explain...
178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know
05 Mar 2025
Contributed by Lukas
In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system elem...
177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED
26 Feb 2025
Contributed by Lukas
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on re...
176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski
19 Feb 2025
Contributed by Lukas
In this episode of Let's Combinate Drugs and Devices, host Subhi Siddhey welcomes Eric Sugalski, founder and CTO of Archimedic. Eric shares insights i...
175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau
12 Feb 2025
Contributed by Lukas
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️Listen to more expert discussions on reg...
174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin
05 Feb 2025
Contributed by Lukas
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️Listen to more expert discussions on reg...
173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's
29 Jan 2025
Contributed by Lukas
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️Listen to more expert discussions on reg...
172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead
22 Jan 2025
Contributed by Lukas
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️Listen to more expert discussions on reg...
171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?
13 Jan 2025
Contributed by Lukas
In this episode of 'Let's Combinate,' host Subhi Saadeh delves into the challenges and complexities of working with prefilled syringes in regulatory, ...
170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)
08 Jan 2025
Contributed by Lukas
By viewing ISO 13485 through the lens of interconnected Plan-Do-Check-Act (PDCA) cycles, Subhi offers a fresh perspective that simplifies the implemen...
169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective
01 Jan 2025
Contributed by Lukas
In this episode, Subhi Saadeh, a seasoned professional in the pharma and medical device industry, shares his insights on whether choosing bioengineeri...
168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth
25 Dec 2024
Contributed by Lukas
In this episode of Let's Combinate, host Subhi Saadeh discusses the significance of audits as a key appraisal activity and draws parallels with person...
167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst
18 Dec 2024
Contributed by Lukas
In this episode of Let's Combinate, host Subhi Saadeh dives into the world of digital transformation in healthcare with Dr. Timothy Aungst, a visionar...
166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success
11 Dec 2024
Contributed by Lukas
Subhi proposes a broader definition of harmonization, not just aligning regulations but also fostering synergy among drug and device teams. Subhi emph...
165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New
04 Dec 2024
Contributed by Lukas
In this episode of Let's Combinate, host Subhi Sadeh is joined by Marta New, CEO of Radyus Research, to discuss the importance of Target Product Profi...
164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790
27 Nov 2024
Contributed by Lukas
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-visibl...
163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle
20 Nov 2024
Contributed by Lukas
In this episode of Let's Combinate, host Subhi Saadeh delves into the significance of ICH Q12 for the pharmaceutical industry, especially concerning e...
162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)
12 Nov 2024
Contributed by Lukas
In this episode, Subhi delves into 'Quality is Free' by Philip Crosby, a seminal book in quality management. Highlighting its personal significance, t...
161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products
06 Nov 2024
Contributed by Lukas
In this episode of Let's Combinate, host Subhi Saadeh explores the essential frameworks of risk management in medical devices and pharmaceuticals: ISO...
160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!
30 Oct 2024
Contributed by Lukas
In this episode of *Let's Combinate*, Subhi delves into the critical distinctions between drug tech transfer and device design transfer, especially pe...
159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin
23 Oct 2024
Contributed by Lukas
In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across vario...
158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show
16 Oct 2024
Contributed by Lukas
In this episode, host Subhi reflects on three years of podcasting, drawing analogies to strength training and discussing the incremental progress achi...
157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura
09 Oct 2024
Contributed by Lukas
In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked...
156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar
02 Oct 2024
Contributed by Lukas
On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc. On this episode, Laxman...
155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach
25 Sep 2024
Contributed by Lukas
On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into th...
154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell
18 Sep 2024
Contributed by Lukas
On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagno...
153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio
11 Sep 2024
Contributed by Lukas
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug De...
152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh
04 Sep 2024
Contributed by Lukas
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). I...
151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio
28 Aug 2024
Contributed by Lukas
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug De...
150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar
21 Aug 2024
Contributed by Lukas
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...
149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens
14 Aug 2024
Contributed by Lukas
On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode D...
148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner
07 Aug 2024
Contributed by Lukas
On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the comple...
147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup
30 Jul 2024
Contributed by Lukas
On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through: David Grosse...
146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens
24 Jul 2024
Contributed by Lukas
On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David walks through the freeze drying(lyo) process, prima...
145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi
17 Jul 2024
Contributed by Lukas
On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory ...
144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo
10 Jul 2024
Contributed by Lukas
On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery. David and I discuss: 00...
143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young
03 Jul 2024
Contributed by Lukas
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 Device...
142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin
26 Jun 2024
Contributed by Lukas
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...
141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)
19 Jun 2024
Contributed by Lukas
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 car...