Podcast

July 24, 2024

146 – Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water’s Triple Point with David Simoens

On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption,

July 17, 2024

145 – Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi

On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: Timestamps 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges

July 10, 2024

144 – Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO’s with David DeSalvo

On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery. David and I discuss: Timestamps 00:00 Introduction and Guest Overview 00:04 David

July 3, 2024

143 – New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young

On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs

June 26, 2024

142 – Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 01:53 Material Qualification Discussion Begins 02:23 Material Qualification

June 19, 2024

141 – Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)

On this episode of the Combinate Podcast, I go over 6 lessons from the life and x of H. James Harrington. Dr. H James Harrington has a decorated career with

June 12, 2024

140 – Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM’s, Evaluating Skill and Mindset with Christian Espinosa

On this episode, I was joined by Christian Espinosa CEO of Blue Goat Cyber. On this episode, Chrsitian walks through: Timestamps 00:00 Introduction and Guest Overview 00:20 Christian Espinosa's Journey:

June 5, 2024

139 – FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh

This is a solo episode. On this episode, Subhi goes through: 01:51 Draft FDA Guidance – Platform TechnologyDesignation Program for Drug Development Guidance for Industry 13:03 EMA Guidance – Questions

May 29, 2024

138 – Operations vs. Quality, KPI’s, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture 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: Timestamps 00:31 Larry's Perspective on Quality 03:21 Importance of

May 22, 2024

137 – The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens

On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, Alan walks through: Timestamps 00:38 Exploring

May 15, 2024

136 – Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura

On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through: Timestamps 00:29 Design Changes When No DHF

May 8, 2024

135 – Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson

On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical. On this episode, Anthony discusses: Timestamps 03:11 The Formation and Impact of

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