On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses: Key Topics Distinguishing differences in framework between the Device QSR/QMS and Drug cGMP’s
On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss: Susan Neadle is a recognized international Combination
On This Episode, I was joined by Harsh Thakkar, CEO of Qualtivate. Harsh walks through: Key Topics Automating Quality with No Code Tools Software Validation Infrastructure Software Out of the
On this episode, I was joined by Peter Birch, CEO and Host of Talking HealthTech. Peter walks through: Key Topics Talking HealthTech Podcast with 350+ Episodes – HealthTech Innovation in
On this episode, I outline an introduction to one of my favorite APQP tools, Production Part Approval Process(PPAP): Key Topics What is PPAP Inputs, Process, Triggers and Interactions PPAP Elements
On this I was joined by Ferdous Al-Faruque, Senior Editor at RAPS. Danny discusses: Key Topics Landing in Medical Devices and Pharma Regulatory Affairs Rules of engagement On the record,
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions. Fran and I discuss: (0:00) Component Machinability (3:47) Stopper/Plunger Coating vs Lamination (13:22)
On this episode I was joined by Jacob Laporte, Co-Founder of the Novartis Biome. Jacob discusses: Dr. Jacob LaPorte is an ex-Harvard chemist and ex-McKinsey consultant who is passionate about
On this episode, I was joined by Marta New, the CEO of Radyus Research. Dr. New discusses: 0:00 Intro 1:37 Pre-Clinical Planning 7:15 What’s the purpose of an IND? 14:10
On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments. Derek walks through: Key Topics (2:30) Holistic Approach to CCI (5:50) Risk
On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. Niedre discusses: Key Topics Common Technical
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: Key Topics ISO TC 84: Needle
