Podcast

September 27, 2023

104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew

On this episode, I was joined by Sara Waxberg MacNew, Chief Scientific Officer at Design Sciences. On this episode Sara and I discuss: Sara Waxberg McNew is the Chief Scientific

September 20, 2023

103 – Prescription Reconciliation, Medication Error Reduction, Automated Home Care, Assisted Robotics, Patient Behavioral Monitoring, and the future of Clinical Trials with Charles Gellman

On this episode, I was joined by Charles Gellman, CEO of HiDO. – How to know people are actually taking their medications- Eliminating Medication Errors in the Home – Medication

September 13, 2023

102 – Human Error, Doing Quality Differently, Defining Accountability, Written Human Guidance, Blue Line vs. Black Line and Categorizing Deviations with Amy Wilson and Cliff Berry

On this episode, I was joined by ⁠ Amy Wilson and Cliff Berry, authors of " Do Quality Differently: The Playbook for Creating More Success in Biopharma (or Any) Manufacturing".

September 6, 2023

101 – Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano

On this episode, I was joined by Megan Polidano, Head of Clinical and Regulatory affairs at Vaxxas. Megan walks through: Micro-Array Patches and Needle Free Injections EPARs and AusPARs Combination

August 30, 2023

100 – PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality 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 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

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