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: Connected Devices and Combination Products How Regulators approach regulatin...
19 Heinä 202336min
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: Supplier Management for Combination Products ...
12 Heinä 202325min
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: • Distinguishing differences in framework between the Device QSR/QMS and Drug cGMP’s • Learnings f...
5 Heinä 202341min
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: Part 1 of The Combination Products Handbook: A...
28 Kesä 202340min
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: - Automating Quality with No Code Tools - Software Validation - Infrastructure Software - Out of the Box - Conf...
21 Kesä 202344min
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: - Talking HealthTech Podcast with 350+ Episodes - HealthTech Innovation in Australia - Audience ...
14 Kesä 202333min
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): - What is PPAP - Inputs, Process, Triggers and Interactions - PPAP Elements and...
7 Kesä 202321min
087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque
On this I was joined by Ferdous Al-Faruque, Senior Editor at RAPS. Danny discusses: • Landing in Medical Devices and Pharma Regulatory Affairs • Rules of engagement • On the record, Off the reco...
31 Touko 202339min
