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Let's Combinate in 2026

44 episodes, newest first.

  1. 2 Nov261Getting Pharma/Device Products Into Clinical Trials: INDs, IDEs & FDA Meetings37m
  2. 26 Oct267What Pharma Wants from CDMOs: Quality, Pricing & TrustKaan Kekec19m
  3. 19 Oct259The Career Lesson I Learned the Hard Way in Pharma5m
  4. 12 Oct258Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin34m
  5. 5 Oct25721 CFR Part 4 Explained: CGMP Requirements for Combination Products12m
  6. 28 Sept256The New FDA Inspection Playbook: Where to Start with QMSR9m
  7. 21 Sept255Audit Interview Techniques: How Good Auditors Get Better Evidence11m
  8. 13 Sept254Saying No Is the Easy Part of Quality12m
  9. 7 Sept253FDA Is Making Big Changes to Its Inspection Approach45m
  10. 31 Aug252Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)13m
  11. 24 Aug251The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy49m
  12. 18 AugI'm Changing The Podcast2m
  13. 12 Aug250PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?11m
  14. 5 Aug249The Best Audit Advice Nobody Told Me14m
  15. 29 Jul248What Is a Quality Unit? QA vs. QC Explained8m
  16. 22 Jul247Why Everyone in Pharma and MedTech Should Work in Quality8m
  17. 15 Jul246The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)8m
  18. 8 Jul245Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector45m
  19. 1 Jul2445 Critical Quality Differences Between Drugs and Devices8m
  20. 24 Jun243Why Kitting A Finished Medical Device with a Drug Create So Much Work14m
  21. 17 Jun242Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start12m
  22. 10 Jun241ICH Q14 Explained: Have We Been Validating Methods Backwards?10m
  23. 3 Jun240ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy11m
  24. 27 May239ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes10m
  25. 20 May239ICH Q11 in 6 Minutes6m
  26. 13 May2386 Audit Strategies Every Auditor Should Know10m
  27. 6 May237ICH Q10: The Pharmaceutical Quality System8m
  28. 29 Apr236ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences12m
  29. 22 Apr235ICH Q8: How Pharmaceutical Development Actually Works10m
  30. 15 Apr234ICH Q7: The GMP Framework for API Manufacturing13m
  31. 8 Apr233Most Teams Misunderstand SpecificationsICH Q66m
  32. 1 Apr232MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk34m
  33. 25 Mar231Audit Findings Explained: Nonconformity vs Observation (CQA)11m
  34. 23 Mar230How Pharma Misses Critical Market Signals with Joe Luminiello30m
  35. 11 Mar229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products31m
  36. 4 Mar228ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently6m
  37. 24 Feb227When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics28m
  38. 18 Feb226Navigating China NMPA Medical Device RequirementsStandards, GMP Updates, Agents & Classification29m
  39. 11 Feb226ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions8m
  40. 4 Feb225ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes9m
  41. 28 Jan224ICH Q2 Explained: What Analytical Validation Really Requires10m
  42. 21 Jan223What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations9m
  43. 14 Jan222How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series12m
  44. 7 Jan221What Is ICH and Why It Matters14m