Episodes
095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, R…
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 Partners and linking to risk file...
094 - Connected Combination Products, Product Traceability, Regulatin…
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 regulating new technologies Traceabil...
093 - Combination Products Handbook Part 2: Supplier Management, Drug…
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 Drug & Device Analytical Tes...
092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS…
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 from Training FDA CDER and...
091 - Combination Products Handbook Part 1: Foundation, Learning from…
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 Practical Guide to Combina...
090 - Software Validation, Automation, No-Code Quality Tools and QMS …
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 - Configured Software - Custom S...
089 - Talking HealthTech Podcast, Consistency, Australian Innovation …
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 and audience building - Working Quiet...
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 Tools - The difference betwe...
087 - From Crime Reporting to Regulatory Affairs and On/Off The Recor…
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 record, On Background • Dann...
086 - Elastomers - Stopper and Plunger Manufacturing, Processing and …
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions. Fran and I discuss: (0:00) Component Machinability (3:47) Stopper/Plunger Coating vs Lamination (13:22) Stopp...
085 - Digital Innovation, Proteomics, Core & Non-Core Innovation, Con…
On this episode I was joined by Jacob Laporte, Co-Founder of the Novartis Biome. Jacob discusses: (1:56)Harvard PhD to Consulting in Innovation Management (11:50)Core & Non-Core Innovation (21:09)Digital Technologies in Pharm...
084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, …
On this episode, I was joined by Marta New, the CEO of Radyus Research. Dr. New discusses: (0:00) Intro (1:37) Pre-Clinical Planning (7:15) What's the purpose of an IND? (14:10) Administration Route Selection (19:00) Candidat...
083 - Holistic Approach to Container Closure Integrity, Capping/Crimp…
On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments. Derek walks through: - (2:30) Holistic Approach to CCI - (5:50) Risk Management and CCI - (7:30) Lyophilized vs. ...
082 - CTD Structure for Combination Products, US vs. EU Submissions a…
On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. Niedre discusses: Common Technical Document Combination Prod...
081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of …
On this episode I was joined by Bob Nesbitt, Chair of ISO TC 84 and Director of Combination Products R&D at Abbvie. Bob discusses: ISO TC 84: Needle Based Injectors, Insulin Syringes, Auto Disable Syringes, On Body Injector...
080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and…
On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments. Derek walks through: CCIT vs. Sterility Testing Difference between Deterministic and Probabilistic Methods 9 CCI ...
079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmon…
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD). Rumi walks through: How FDA Reviews Combination Products Industry's role in shaping policy Essential Performance Requirement...
078 - Preventation is Not New, Incentives in Health Care, and Integra…
On this episode, I was joined by Ramin Rafiei PhD, CEO of Unleash Health. Ramin discusses: Experiences in Integrating Combination Products and Digital Health Prevention + Intervention in Health Care Incentives and Outcomes Un...
077 - 8 Databases and How To Use Them with Michelle Lott
On this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them! If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michel...
076 - GMP Training, Competence, Human Error and Mentorship with Joann…
On this episode, I was joined by Joanna Gallant of JGTA. Joanna walks through: Training programs at companies that had consent decrees The difference between good training and bad GMP training Competence in knowledge work Hum...
075 - Shortages, Pricing, Mastering New Skills, and Building Deep Und…
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - FDA Drug Shortages Report - Drug Shortages and Drug Pricing - How he approaches Mastering new skill set...
074 - Article 117, EU MDR extension, Notified Body Opinions, Timing a…
On this episode, I was joined by Christiana Hoffman, Executive Consultant & Business Development Manager at anteris medical GmbH. Christiana walks through: - Article 117 requirements for Combination Products in EU - Notified ...
073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Man…
On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses: The Anatomy of a Hazard Hazard Source(HS), Initiating Mech...
072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epic…
On this episode, I was joined by Dan Formosa, legendary designer and founder of ThinkActHuman. On this episode, Dan walks through: The importance of eliminating the need for instruction through good design His experience w...