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
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
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD). Rumi walks through: Key Topics How FDA Reviews Combination Products Industry's role in shaping
On this episode, I was joined by Ramin Rafiei PhD, CEO of Unleash Health. Ramin discusses: Dr Ramin Rafiei is a senior executive and entrepreneur in healthcare and life sciences,
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
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
