Subhi Saadeh public
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Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to li ...
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On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry.Devon discusses: 02:20 The Journey to Consulting: A Year of Saying No 03:09 Advising Startups: The Role of a Consultant 05:08 The Shift to Consulting: Embracing Joy and Impact 09:21 Navigating the Startup Ecosystem: Challenges and Opportunities 13:31 Building a P…
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On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses: 00:56 Evolution of Industry Standards 02:00 The Impact of Standards on Medical Device Development 02:10 Standards and Regulatory Challenges 02:42 Standards in Medical Devices and Emerging Technologies 13:19 The Auditing…
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On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss:- Assessing Drugs, Devices, and Combination Products for Sterility Methods- Regulatory Frameworks and EMA's Decision Tree (Link)- Novel Methods: liquid phase sterilization, ionization, physics based sterilization, high pressure s…
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On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses: 00:58 Exploring the Impact of QMSR on Medical Device Companies 02:19 UDI Regulations 05:18 Understanding the FDA's Approach to QMSR and Compliance 18:02 The FDA's Inspection Techniques and the Future of QMSR 31:55 Where to Find Aaron and Closing Thoug…
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On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about how reliability engineering concepts can be used for single use combination products. Why infusion pumps are susceptible to recalls. Why people call Allen captain Allen Stevens. A…
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On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso. Vin discusses: 01:35 Journey from Premed to FDA Investigator: VIN's Story 07:25 Understanding the Impact of QMSR on Industry 16:24 The FDA's Approach to Inspections and Compliance 27:45 The Shift Towards Quality Culture in F…
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On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk". In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode covers the confusion surrounding the mandatory nature of risk management in particular and we spend the seco…
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On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses: 01:02 Venturing into Combination Products 02:46 Andy's Journey into Healthcare Space 04:48 Challenges in Deep Brain Stimulation 08:55 The Impact of working with Andy Grove 10:42 The Struggle with Parkinson's Disease 13:20 The Speed of Product Deve…
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On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024. 0:00 Introduction 05:09 Initial Reactions to the idea of the QMSR 06:57 History of the Device cGMP's, QSR, and QMSR 11:52 What's changing in 21 CFR 820? 24:59 What's changing in 21 CFR …
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On this episode, I was joined by Andy Robertson, founder of CQE Academy. In this episode, Andy outlines 5 steps to becoming an exceptional quality engineer, such as seeking mentorship, taking on challenging assignments, and being a lifelong learner. Andy stresses the importance of honing soft skills for effective leadership and suggest stepping out…
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On this episode, I was joined by Peter Baker, President @ Live Oak QA. The conversation revolves around the speaker's experience working with the FDA, starting from his time in San Francisco and culminating in his experiences in international locations like India and China. The discussion outlines the FDA's diverse focus areas, from food to medical…
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On this episode, I was joined by Jim Fries, CEO of Rx360. On this episode, Jim discusses the critical aspects of audits in medical technology and pharmaceutical sectors. He provides insight into the joint audit program that RX-360 rolled out, its working, and benefits. He addresses the challenges faced, emphasizing the need for relationship buildin…
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On this episode, I was joined by Sayed Badrawi, Pharma/MedTech Investor and Board Member. Sayed walks through starting at Amgen as a bench scientist and transitioning to the commercial side of the Pharma industry. Sayed provides advice for people considering their career paths and emphasizes the importance of gaining expertise in a particular area …
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In this special episode of the comedy podcast, host Subhi Sade welcomes Munir Al Azouzi, the founder of Easy Medical Device. Munir shares his expertise on the often confusing topic of the EU’s Medical Device Regulation (EUMDR), focusing on the distinctions between roles such as legal manufacturer, distributors, importers, authorized reps, and perso…
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On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David discusses his broad background, including his roles in quality manufacturing, product development, and technical transfer. He delves into the differences between isolators and RABs—two types of equipment used in clean rooms, critical for sterile process…
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On this episode, I was joined by Douglass(Doug) Mead, Combination Products Expert and Founder of CP Pathways. Doug presents a thorough walkthrough of drug master files (DMFs) and device master files (MAFs), their types, and their differences. Drawing on his industry experience, he explains advantages, challenges, and practical ways to handle and ma…
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On this episode, I was joined by Khaudeja Bano, VP of Quality for Combination Products at Amgen. In this episode, the we discuss the details related to post-market safety reporting for combination products. The conversation extends to the comparison connecting safety and quality, the importance of cross-functional teams for risk management, and the…
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In this episode, I was joined by Jeanne Moldenhauer, a sterilization expert to discuss all things gas sterilization. Jeanne and I explore how efficiency is determined by the seal of the container and the type of material being sterilized. Jeanne discusses its application in medical devices, the challenge of permeability, and its comparative cost-ef…
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On this episode, I was joined by Katherine Eban, the New York Times best-selling author of "Bottle of Lies". In this episode, Katherine dives deep into her decade-long investigation into the quality issues prevalent in generic drug manufacturing overseas. Eban highlights the need for improving transparency in the pharmaceutical industry. She shares…
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On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne talks through the different methods of irradiation like gamma, beta, microwave, x-ray, and ebeam, their respective pros and cons, as well as their environmental impacts. Jeanne also delves into the practical considerations associated with this…
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On this episode, I was joined by Ira Mann, President at IQ Referrals. Ira and I discuss: - Pharma/MedTech Market and Positioning for Success - Why people leave good companies - Finding Motivation in Pharma/Quality - Remote Work, Insourcing, On-Shoring in US Manufacturing Ira Mann is President, IQ Referrals. With more than 20 years in the recruiting…
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On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting.Jeanne and I discuss: -Steam Sterilization - Moist and Dry Heat-Biological/Chemical Indicators, Placement and Resistance -Cycle Development and Validation-Overkill Cycles vs Product Specific Cycles -Parametric Release of Steam Sterilized Products Jean…
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On this solo episode, I go through a list of 7 books I recommend for med tech, biotech and combination product professionals. The books are: Quality is Free by Phillip Crosby The Combination Products Handbook by Susan Needle What Country has the Best Healthcare by Ezekiel Emanuel Switch by Dan and Chip Heath Managing Oneself by Peter Drucker Bottle…
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On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: Dealing with CDMO's and CXO's Supply Chain and Logistics and Pharma and Medical Devices Reverse Knowledge Transfer Building Trust with CXO's and Leveraging Surveys The future of the CDMO Market Ben Locwin is a Healthcare Executive…
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On this episode, I was joined by Martin Van Trieste, Author of Protecting the Patient at All Costs: The Drug Watch Dogs and is the Former Chief Quality Officer at Amgen and Former CEO at Civica Rx. Martin and I discuss: - Protecting the Patient at All Costs - Quality Leadership and being a Chief Quality Officer in Big Pharma - Supply Chain Security…
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On this episode I was joined by Margaret Jenkins, who's the Founder and Principal at Global Pharma Solutions. Margaret and I discuss: Clinical Data interpretation and authoring eCTD Module 2 Overview Learning drug assays with a device background Non-Clinical eCTD Module 4 Clinical eCTD Module 5 Margaret Jenkins is the Founder and Principal at Globa…
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On this episode I was joined by Michelle Wu, CEO and Founder of Nyquist. On this episode Michelle and I discuss:- Pre-Trained Models and Generative AI- Distilling Decades of MedTech Data/Historical Data Review - Adopting new technologies in Quality and Regulatory Affairs- Removing the tribal knowledge barrierMichelle Wu is the Founder and CEO of Ny…
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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, 077, 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 with re…
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On this episode, I was joined by Nathan Roman, an expert in temperature mapping and environmental validation. On this episode, Nathan and I discuss: - Temperature Mapping and Monitoring - Validation and Commissioning - Changes in Data Logger Technology - Cold Chain vs. Ambient Nathan Roman is a highly accomplished expert in equipment commissioning,…
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On this episode, I reflect on 8 lessons I learned from recording 100 Episodes of the Combinate Podcast and Ironman Chatanooga. Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development an…
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On this episode, I was joined by Sara Waxberg MacNew, Chief Scientific Officer at Design Sciences. On this episode Sara and I discuss: New FDA Guidance: Critical Task Definition for Combination Products Pre-Clinical HF Studies in readiness for IND Submission URRA Human Factors Validation vs. Design Validation Sara Waxberg McNew is the Chief Scienti…
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On this episode, I was joined by Charles Gellman, CEO of HiDO. - How to know people are actually taking their medications- Eliminating Medication Errors in the Home - Medication Reconciliation, Drug Libraries and Dealing with Contraindications- Clinical Trial Monitoring in the Future- Chaining Technology and Re-Training Behavioral ChangeCharles Gel…
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On this episode, I was joined by ⁠Amy Wilson and Cliff Berry, authors of "Do Quality Differently: The Playbook for Creating More Success in Biopharma (or Any) Manufacturing". Amy and Cliff walkthrough: Human Performance and Challenges Defining Accountability from a Quality World-View Good Written Human Guidance Automating Procedure and QMS Feedback…
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On this episode, I was joined by Megan Polidano, Head of Clinical and Regulatory affairs at Vaxxas. Megan walks through: Micro-Array Patches and Needle Free Injections EPAR's and AusPAR's Combination Products in Australia Clinical Trials in Australia Australia Regulatory Pathways - Core A and Core B Megan Polidano is the Head of Clinical and Regula…
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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 …
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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…
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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 g…
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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 t…
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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…
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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 AuditNaveen Agarwal PhD is an Engineer by training with nearly 20 years of professio…
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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 …
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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 Neadl…
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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 …
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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 an…
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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…
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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 memb…
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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 Profes…
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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 publishingFerdous Al-Faruque, known as Danny, is Senior Editor at RAPS and specializes in report…
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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 Soluti…
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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-McKinse…
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