On this episode, I was joined by Janine Jamieson, European Editor at International Pharmaceutical Quality. In this episode, Janine walks through: -Medical Device vs. Medicinal Product Reviews in the EU
On this episode I was joined by Bijan Elahi, Award winning Medical Device Risk Management author, educator and consultant. Bijan walks through: Bijan Elahi has worked in risk management for
On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through: Larry is the Principal and Founder at Mgmt-Ctrl, a
On this episode I was joined by Heather Johnson who's the CEO of Ingenium. In this episode, expect to learn: Key Topics Why Waste Management in Pharma might be more
On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal. In this episode, Naveen discussses: Key Topics How FMEA's fit into ISO14971
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD). Rumi walks through: Rumi Young, Meng, RAC is the Director of Regulatory Policy at
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 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 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