Podcast

August 23, 2023

099 – Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson

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

August 16, 2023

098 – MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi

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

August 9, 2023

097 – Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager

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

August 2, 2023

096 – Pharma Waste Management, Sustainability, What Happens to Sharps, Disposal and Zero Waste with Heather Johnson

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

July 26, 2023

095 – How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN’s, pFMEA’s and making it simpler with Naveen Agarwal

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

July 19, 2023

094 – Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young

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

July 12, 2023

093 – Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle

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

July 5, 2023

092 – Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder

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

June 28, 2023

091 – Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle

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

June 21, 2023

090 – Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar

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

June 14, 2023

089 – Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch

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

June 7, 2023

088 – Production Part Approval Process(PPAP) with Subhi Saadeh

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

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