Episodes
092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder
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091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle
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090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar
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089 - Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch
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088 - Production Part Approval Process(PPAP) with Subhi Saadeh
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087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque
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086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with Fran DeGrazio
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085 - Digital Innovation, Proteomics, Core & Non-Core Innovation, Consulting after Academia, Democratizing Access and Clinical Trials with Jacob Laprote
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084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New
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083 - Holistic Approach to Container Closure Integrity, Capping/Crimping, RSF, and Annex I/USP 1207 Requirements with Derek Duncan
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082 - CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R with Niedre Heckman
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081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt
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080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan
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079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young
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078 - Preventation is Not New, Incentives in Health Care, and Integrated Combination Products with Ramin Rafiei
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077 - 8 Databases and How To Use Them with Michelle Lott
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076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant
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075 - Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin
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074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman
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073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal
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072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa
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071 - "Running in my Steel toes" with Etienne Nichols
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070 - "Humbled and Surprised" with Paul Jansen
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