Combinate Podcast - Combining Drugs and Devices
155 episodes - English - Latest episode: about 19 hours ago -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 listen and together we can simplify by Combinating!
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Episodes
133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell
April 24, 2024 09:00 - 22 minutes - 41.1 MBOn 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 Positive Team Culture and Avoiding Arrogance 19:12 The Philosophy Behind Prodct: Focusing on Medical Devices 20:55 A Personal Touch: The...
132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner
April 17, 2024 10:00 - 31 minutes - 57.1 MBOn 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 Experience 17:59 The Challenge of Maintaining and Updating Standards 29:49 Concluding Thoughts and Where to Find More Information Leo E...
131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer
April 10, 2024 10:00 - 42 minutes - 78.5 MBOn 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 sterilization, glass bead sterilization, infrared, microwave Jeanne Moldenhauer is subject matter expert on a variety of sterilization and valida...
130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder
April 03, 2024 10:00 - 32 minutes - 59.4 MBOn 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 Thoughts Aaron Snyder is a quality management systems expert and is the VP of QA at Allotex. Prior to joining Allotex, Aaron served in roles at ...
129 - Reliability for Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens
March 27, 2024 10:00 - 32 minutes - 60.4 MBOn 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. And the roles of standards and guidance in combination product approval. 03:32 The Story Behind 'Captain' Allen Stevens 06:52 The Challenges of ...
128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture
March 20, 2024 10:00 - 52 minutes - 96.2 MBOn 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 FDA Inspections 31:07 Real-World Insights 35:34 The Impact of Quality Culture on Inspections 44:22 Transitioning from FDA to Industry 49...
127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal
March 13, 2024 10:00 - 48 minutes - 88.7 MBOn 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 second half of the episode talk about risk acceptability charts, risk & quality policy, explaining vs. justifying risk based decision making with re...
126 - Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd
March 06, 2024 11:00 - 35 minutes - 65.8 MBOn 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 Development 16:09 Collaboration Challenges in Combination Product Space 19:17 The Role of Regulatory Teams 23:12 The Importance of Team Forma...
125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh
February 28, 2024 11:00 - 42 minutes - 77.1 MBOn 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 4 and Combination Products 33:20 Comments Review and Final Thoughts Links: QMSR Final Rule Amendments: https://www.federalregister.gov/d...
124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson
February 21, 2024 11:00 - 31 minutes - 56.8 MBOn 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 of the comfort zone by exploring opportunities outside the quality field. The discussion also highlighted the value of certification courses fo...
123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker
February 14, 2024 11:00 - 45 minutes - 82.9 MBOn 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 devices and clinical trials, and how operational changes in the mid-2010s streamlined FDA's specialized areas. The speaker discusses his inspect...
122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries
February 07, 2024 11:00 - 35 minutes - 65.9 MBOn 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 building and constant growth via listening and questioning. Lastly, he invites audience feedback to continually improve the show. 00:04 Guest Introduct...
121 - Bench Scientist to Commercial Leader, Amgen in the early days, Challenges in Commercialization, Working in Startups vs. Large Companies, and Silos with Sayed Badrawi
January 31, 2024 11:00 - 33 minutes - 61.2 MBOn 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 before making significant career changes. He also highlights some of the challenges and opportunities in the Pharma industry, including the imp...
120 - EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi
January 24, 2024 11:00 - 43 minutes - 78.9 MBIn 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 persons responsible for regulatory compliance. Munir explains the need for compliance checks, supply chain management, traceability documentation, ...
119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens
January 18, 2024 15:05 - 26 minutes - 48.4 MBOn 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 processing. David also starts to touch on the standards and parameters set by the EU and ISO, and he suggests various resources, including Annex one and...
118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead
January 10, 2024 11:00 - 37 minutes - 69.4 MBOn 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 maintain these files in biopharma companies. Doug provides case examples, discusses trends, future prospects of DMFs and MAFs, and offers advice fo...
117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano
January 03, 2024 11:00 - 34 minutes - 63.3 MBOn 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 approach towards health hazard assessments. Additionally, they delve into managing product responsibilities, the varied international reporting ...
116 - Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer
December 27, 2023 11:00 - 39 minutes - 73 MBIn 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-effectiveness. Jeanne delves into how the sterilization process works, safety considerations, validation, and the use of gas sterilization in combi...
115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban
December 20, 2023 11:00 - 33 minutes - 61.5 MBOn 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 some inspiring stories of dedicated professionals in the industry who strive to ensure patients receive quality. Eban also discusses her findin...
114 - Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer
December 13, 2023 11:00 - 43 minutes - 79.9 MBOn 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 sterilization method. This includes important factors like product density, cycle development, dosimeters, sterilization and the bioburden. Th...
113 - Pharma/MedTech Market, Why Good People Leave, Finding Motivation, Onshoring in Pharma and Motivation with Ira Mann
December 06, 2023 11:00 - 28 minutes - 52.8 MBOn 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 industry, Ira is an expert at placing top professionals in the Quality, Validation, Regulatory Affairs, Cold Chain, Environmental Monitoring...
112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer
November 29, 2023 11:00 - 47 minutes - 86.9 MBOn 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 Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has bee...
111 - 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh
November 22, 2023 11:00 - 19 minutes - 36.6 MBOn 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 of Lies by Katherine Evan The Pyramid Principle by Barbara Minto I find that I read a lot more in December so wanted to give you all s...
110 - CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin
November 15, 2023 11:00 - 31 minutes - 58.1 MBOn 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, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.
109 - Protecting Patients at All Costs, Being a CQO in Big Pharma, Supply Chain Security and Generic Drugs with Martin Van Trieste
November 08, 2023 13:15 - 42 minutes - 77.5 MBOn 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 - Generic Drugs and Shortages Martin Van Trieste is an accomplished entrepreneur, board governance expert, executive coach and biopharmaceu...
108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins
November 01, 2023 10:00 - 38 minutes - 70.4 MBOn 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 Global Pharma Solutions where she works closely with clients to provide strategic solutions, allowing them to follow the most efficient pathway t...
107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu
October 25, 2023 09:00 - 32 minutes - 59.2 MBOn 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 barrier Michelle Wu is the Founder and CEO of NyquistData Inc. Michelle has over seven years of experience in strategic planning, business development, and global strategy. Prior to NyquistD...
106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott
October 24, 2023 02:59 - 33 minutes - 30.8 MBOn 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 regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief couns...
106 - Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman
October 11, 2023 10:00 - 32 minutes - 30.3 MBOn 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, qualification, and validation, with over 23 years of hands-on experience in the Health & Life Science industry. In his current role, he succ...
105 - Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi Saadeh
October 04, 2023 10:00 - 27 minutes - 25.8 MBOn 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 and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the I...
104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew
September 27, 2023 09:00 - 36 minutes - 33.8 MBOn 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 Scientific Officer at Design Science, a human factors firm that specializes in healthcare. Sara has held roles previously in user centered design...
103 - Prescription Reconciliation, Medication Error Reduction, Automated Home Care, Assisted Robotics, Patient Behavioral Monitoring, and the future of Clinical Trials with Charles Gellman
September 20, 2023 10:00 - 29 minutes - 27 MBOn 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 Change Charles Gellman is the CEO & Co-Founder of HiDO Health. NIH funded research in collaboration with Stanford and Rush Universities. He is one of the top...
102 - Human Error, Doing Quality Differently, Defining Accountability, Written Human Guidance, Blue Line vs. Black Line and Categorizing Deviations with Amy Wilson and Cliff Berry
September 13, 2023 10:00 - 32 minutes - 30 MBOn 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 Categorizing Deviations Appropriately Blue Line vs. Black Line: Work as Imagined vs. Work as Completed Amy Wilson: Amy has more than 20 ...
101 - Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano
September 06, 2023 12:00 - 29 minutes - 27.4 MBOn 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 Regulatory affairs at Vaxxas. Megan has worked in regulatory affairs since 2007 and have worked for large pharmaceutical and medical device comp...
100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager
August 30, 2023 10:00 - 30 minutes - 28.2 MBOn 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 Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality man...
099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson
August 23, 2023 10:00 - 40 minutes - 37.3 MBOn 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 Structure -Writing about combination products in the EU Janine is European Editor at IPQ (Inter...
098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi
August 16, 2023 10:00 - 40 minutes - 37.1 MBOn 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 worked in risk management for medical devices for over 29 years at the largest medical ...
097 - Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager
August 09, 2023 10:00 - 43 minutes - 40 MBOn 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 compliance only. He has three decades of experience in the medical device industry, and has hel...
096 - Pharma Waste Management, Sustainability, What Happens to Sharps, Disposal and Zero Waste with Heather Johnson
August 02, 2023 10:00 - 20 minutes - 18.7 MBOn 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 Johnson has over 25 years of expertise in the hazardous waste management industry as a C-level Exec...
095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal
July 26, 2023 10:00 - 43 minutes - 40.3 MBOn 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 Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all...
094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young
July 19, 2023 10:00 - 36 minutes - 33.4 MBOn 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 Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that ad...
093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle
July 12, 2023 12:00 - 25 minutes - 23.9 MBOn 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 Products, Medical Device, and Digital Health expert with over 35 years industry experience. She...
092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder
July 05, 2023 10:00 - 41 minutes - 38.2 MBOn 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 Aaron Snyder is a quality management systems expert and is currently VP of QA at Allotex...
091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle
June 28, 2023 10:00 - 40 minutes - 73.6 MBOn 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 recognized international Combination Products, Medical Device, and Digital Health expert with ove...
090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar
June 21, 2023 10:00 - 44 minutes - 80.6 MBOn 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 spent more than a decade in quality assurance and regulatory compliance roles with companie...
089 - Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch
June 14, 2023 10:00 - 33 minutes - 31.3 MBOn 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 technology in healthcare. In addition, Pete is a director of the Medical Software Industry Associ...
088 - Production Part Approval Process(PPAP) with Subhi Saadeh
June 07, 2023 10:00 - 21 minutes - 40 MBOn 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 background in Quality, Manufacturing Operations and R&D he's worked in Large Medical D...
087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque
May 31, 2023 10:00 - 39 minutes - 36.9 MBOn 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 technologies such as mobile health, combination products, unique device identifiers, and iss...
086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with Fran DeGrazio
May 24, 2023 10:00 - 30 minutes - 28.6 MBOn 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 Officer at West Pharmaceuticals.She has been in the pharmaceutical packaging industry for over 35 years...
085 - Digital Innovation, Proteomics, Core & Non-Core Innovation, Consulting after Academia, Democratizing Access and Clinical Trials with Jacob Laprote
May 17, 2023 10:00 - 36 minutes - 66.2 MBOn 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 digital transformations to improve healthcare for patients. Jacob founded and led The BIOME by...