Podcast

August 28, 2024

151 – Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses: Timestamps

August 21, 2024

150 – Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar

On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses: 00:00 Welcome to Episode 150! 03:00 Challenges

August 14, 2024

149 – Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens

On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode David discusses: 01:01 Recap of the Last Episode

August 7, 2024

148 – Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of

July 30, 2024

147 – URRA Draft Guidance, uFMEA’s, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup

On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through: David Grosse-Wentrup PhD is a Research Director at Design

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:

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