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: Predictive Quality Management and PDCA Business Process Capabilities and ...
9 Aug 202343min
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: • Why Waste Management in Pharma might be more complicated than you might think • Differe...
2 Aug 202320min
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: - How FMEA's fit into ISO14971 - pFMEA's from External Partner...
26 Juli 202343min
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 Juli 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 Juli 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 Juli 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 Juni 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 Juni 202344min
