Let's Combinate - Drugs + Devices

On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through: Episode 100 and the first recording with Larry! Quality - Big Q/little q Building a QMS and Commercializing a product at a startup Predictive Quality Management, PDCA and TOC Lessons from Pharma, Combination Products, and CRO Companies Communicating quality Larry is the Princ...

On this episode, I was joined by Janine Jamieson, European Editor at International Pharmaceutical Quality. In this episode, Janine walks through: -Medical Device vs. Medicinal Product Reviews in the EU -Working at MHRA as a Pre-Market Reviewer on Devices with an Ancillary Medicinal Substance -Notified Bodies, EU MDR and Article 117 -European Commission, Member States and European Member States Str...

On this episode I was joined by Bijan Elahi, Award winning Medical Device Risk Management author, educator and consultant. Bijan walks through: MedTech vs. Aerospace - Differences in Risk Management Approaches Risk Control/Reduction - AFAP vs. ALARP or ALARA and Global Requirements Quantifying Benefit and Benefit/Risk Risk Control Measures What a good risk management process looks Bijan Elahi has...

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 process stewardship 3 Lines of Quality Defense COSO Risk Management Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond comp...

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 • Different kinds of sharps, why sharps are challenging and what happens to sharps containers? • Waste potential and repurposing orphan chemicals • And what Zero Waste means for sustainability Heather Johnso...

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 files - Simplifying Risk Management outputs for Audit Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality...

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 Traceability Technologies and what they mean for manufacturing and use Comparability Protocols and Pre-Determined Change Controls for Drugs and Devices Rumi Young, Meng, RAC is the Dir...

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 Testing Considerations for Biologics Connected/Digital Health Changing Regulatory Landscape for Combination Products Susan Neadle is a recognized international Combination Pr...

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 CBER on device requirements • Lessons from being Head of QA at a manufacturing site and internal audit • Teaching through AAMI and his YouTube channel: Quality Systems Explained...

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 Combination Products and Other Combined Use Systems: Foundation Subhi's questions on each chapter What she learned from authoring and coordinating of the book Susan Neadle is a r...

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 Software Systems Harsh Thakkar is the CEO and founder of Qualtivate, a data-driven quality management consulting firm for life sciences.  He is an industry veteran who has spen...

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 building - Peter/TH's Creative Process for Podcasting (2/3/4 episodes per week) Peter Birch is Founder and CEO of Talking HealthTech - a podcast and membership community to learn and connect about...

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 between first article inspection(FAI) and Capability Studies - Applications and Challenges in use Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a b...

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 • Danny's Process in writing, editing and publishing Ferdous Al-Faruque, known as Danny, is Senior Editor at RAPS and specializes in reporting on regulatory affairs, new medical device tec...

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) Stopper/Plunger Manufacturing (26:14) USP 381/382 Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Office...

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 Pharma (27:39)Democratizing Access and Clinical Trials (32:35)Proteomics Dr. Jacob LaPorte is an ex-Harvard chemist and ex-McKinsey consultant who is passionate about leading d...

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) Candidate Selection and Animal Models (30:10) Pre-IND Meeting (44:00) IND Submissions and Approval Marta New PhD MBA is the CEO of Radyus Research. She is an experienced drug deve...

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. Liquid CCI - (12:20) Capping/Crimping Parameters and Residual Seal Force(RSF) - (14:30) EU Annex I and USP 1207 Requirements Dr. Duncan began his career at the Dutch Institute...

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 Products Structure for eCTD Submissions * EU vs. US Submission Expectations * Design Controls and Human Factors data placement * Regulatory Roles and Responsibilities in Pharma N...

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 Injectors, Sharps Prevention, Cartridge Based Pen Injectors, Inhalers, Single use Drug Delivery devices, Catheters, etc - Crazy Bob's Medical Device - Relationship between AAMI, ANSI,...

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 Test Methods in 9 Minutes - CCI vs. Permeation Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry...

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 Requirements - IMDRF and International Harmonization Opportunities Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a tea...

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 Unleashing consumer brands to improve health Dr Ramin Rafiei is a senior executive and entrepreneur in healthcare and life sciences, specializing in profitable top-line growth a...

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 Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today. Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies...

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 Human Error  Joanna Gallant is an experienced, solutions-driven Quality and training professional who has spent more than 30 years in pharmaceutical, biotechnology, tissue c...