Hardware Podcasts
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Let's Combinate in 2023

52 episodes, newest first.

  1. 27 Dec116Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer39m
  2. 20 Dec115Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban33m
  3. 13 Dec114Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer43m
  4. 6 Dec113Pharma/MedTech Market, Why Good People Leave, Finding Motivation, Onshoring in Pharma and Motivation with Ira Mann28m
  5. 29 Nov112Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer47m
  6. 22 Nov1117 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh19m
  7. 15 Nov110CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin31m
  8. 8 Nov109Protecting Patients at All Costs, Being a CQO in Big Pharma, Supply Chain Security and Generic Drugs with Martin Van Trieste42m
  9. 1 Nov108Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins38m
  10. 25 Oct107Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu32m
  11. 24 Oct106FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott33m
  12. 11 Oct106Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman32m
  13. 4 Oct105Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi Saadeh27m
  14. 27 Sept104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew36m
  15. 20 Sept103Prescription Reconciliation, Medication Error Reduction, Automated Home Care, Assisted Robotics, Patient Behavioral Monitoring, and the future of Clinical Trials with Charles Gellman29m
  16. 13 Sept102Human Error, Doing Quality Differently, Defining Accountability, Written Human Guidance, Blue Line vs. Black Line and Categorizing Deviations with Amy Wilson and Cliff Berry32m
  17. 6 Sept101Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano29m
  18. 30 Aug100PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager30m
  19. 23 Aug099Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson40m
  20. 16 Aug098MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi40m
  21. 9 Aug097Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager43m
  22. 2 Aug096Pharma Waste Management, Sustainability, What Happens to Sharps, Disposal and Zero Waste with Heather Johnson20m
  23. 26 Jul095How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal43m
  24. 19 Jul094Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young36m
  25. 12 Jul093Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle25m
  26. 5 Jul092Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder41m
  27. 28 Jun091Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle40m
  28. 21 Jun090Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar44m
  29. 14 Jun089Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch33m
  30. 7 Jun088Production Part Approval Process(PPAP) with Subhi Saadeh21m
  31. 31 May087From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque39m
  32. 24 May086Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with ⁠Fran DeGrazio⁠30m
  33. 17 May085Digital Innovation, Proteomics, Core & Non-Core Innovation, Consulting after Academia, Democratizing Access and Clinical Trials with Jacob Laprote36m
  34. 10 May084Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New50m
  35. 3 May083Holistic Approach to Container Closure Integrity, Capping/Crimping, RSF, and Annex I/USP 1207 Requirements with Derek Duncan27m
  36. 26 Apr082CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R with Niedre Heckman43m
  37. 19 Apr081ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt47m
  38. 12 Apr0809 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan25m
  39. 5 Apr079How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young35m
  40. 29 Mar078Prevention is Not New, Incentives in Health Care, and Integrated Combination Products with Ramin Rafiei42m
  41. 22 Mar0778 Databases and How To Use Them with Michelle Lott22m
  42. 15 Mar076GMP Training, Competence, Human Error and Mentorship with Joanna Gallant28m
  43. 8 Mar075Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin33m
  44. 1 Mar074Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman28m
  45. 22 Feb073Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal19m
  46. 15 Feb072OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa53m
  47. 8 Feb071Steel Industry to MedTech & Important Quality Systems with Etienne Nichols59m
  48. 1 Feb070The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen50m
  49. 25 Jan069EU MDR Extension with Michelle Lott17m
  50. 18 Jan068Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge47m
  51. 11 Jan067mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True47m
  52. 4 Jan066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio55m