Hardware Podcasts
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Let's Combinate in 2024

52 episodes, newest first.

  1. 25 Dec168Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth13m
  2. 18 Dec167Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst41m
  3. 11 Dec166Sync or Sink: 3 Levels of Harmonization for Combination Product Success20m
  4. 4 Dec165Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New1h 10m
  5. 27 Nov164Tiny Particles, Big Impact: Breaking down USP 788 & USP 79013m
  6. 20 Nov163ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle11m
  7. 12 Nov162Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)17m
  8. 6 Nov161ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products24m
  9. 30 Oct160Drug Tech Transfer vs. Device Design Transfer EXPLAINED!19m
  10. 23 Oct159Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin22m
  11. 16 Oct1583 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show21m
  12. 9 Oct157Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura21m
  13. 2 Oct156Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar33m
  14. 25 Sept155FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach25m
  15. 18 Sept154IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell37m
  16. 11 Sept153USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio21m
  17. 4 Sept152Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh40m
  18. 28 Aug151Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio33m
  19. 21 Aug150Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar38m
  20. 14 Aug149Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens33m
  21. 7 Aug148Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner26m
  22. 30 Jul147URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup23m
  23. 24 Jul146Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens35m
  24. 17 Jul145Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi40m
  25. 10 Jul144Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo35m
  26. 3 Jul143New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young29m
  27. 26 Jun142Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin30m
  28. 19 Jun141Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)23m
  29. 12 Jun140Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa30m
  30. 5 Jun139FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh27m
  31. 29 May138Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager47m
  32. 22 May137The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens18m
  33. 15 May136Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura39m
  34. 8 May135Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson41m
  35. 1 May134ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch41m
  36. 24 Apr133A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell22m
  37. 17 Apr132IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner31m
  38. 10 Apr131Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer42m
  39. 3 Apr130QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder32m
  40. 27 Mar129Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens32m
  41. 20 Mar128Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture52m
  42. 13 Mar127BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal48m
  43. 6 Mar126Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd35m
  44. 28 Feb125Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh42m
  45. 21 Feb1245 Steps to Becoming a Phenom Quality Pro with Andy Robertson31m
  46. 14 Feb123Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker45m
  47. 7 Feb122Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries35m
  48. 31 Jan121Bench Scientist to Commercial Leader, Amgen in the early days, Challenges in Commercialization, Working in Startups vs. Large Companies, and Silos with Sayed Badrawi33m
  49. 24 Jan120EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi43m
  50. 18 Jan119What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens26m
  51. 10 Jan118What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead37m
  52. 3 Jan117Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano34m