081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt
On this episode I was joined by Bob Nesbitt, Chair of ISO TC 84 and Director of Combination Products R&D at Abbvie. Bob discusses: - ISO TC 84: Needle Based Injectors, Insulin Syringes, Auto Disable ...
19 Apr 202347min
080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan
On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments. Derek walks through: - CCIT vs. Sterility Testing - Difference between Deterministic a...
12 Apr 202325min
079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD). Rumi walks through: - How FDA Reviews Combination Products - Industry's role in shaping policy - ...
5 Apr 202335min
078 - Prevention is Not New, Incentives in Health Care, and Integrated Combination Products with Ramin Rafiei
On this episode, I was joined by Ramin Rafiei PhD, CEO of Unleash Health. Ramin discusses: Experiences in Integrating Combination Products and Digital Health Prevention + Intervention in Health Ca...
29 Mars 202342min
077 - 8 Databases and How To Use Them with Michelle Lott
On this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them! If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulator...
22 Mars 202322min
076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant
On this episode, I was joined by Joanna Gallant of JGTA. Joanna walks through: Training programs at companies that had consent decrees The difference between good training and bad GMP training Com...
15 Mars 202328min
075 - Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - FDA Drug Shortages Report - Drug Shortages and Drug Pricing - How he approa...
8 Mars 202333min
074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman
On this episode, I was joined by Christiana Hoffman, Executive Consultant & Business Development Manager at anteris medical GmbH. Christiana walks through: - Article 117 requirements for Combination P...
1 Mars 202328min
