Welcome to the Yosemite Can O Peaches, a Radio Podcast by John P. DeGrazio. Join me as I explore the trails of Yosemite with local experts as we share our can o peaches and the sweet rewards of Yosemite National Park.
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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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153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio
21:56
21:56
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system…
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154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell
37:31
37:31
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37:31
On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma en…
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152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh
40:48
40:48
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This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380). In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and…
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151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio
33:38
33:38
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33:38
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses: 00:00 Introduction 02:29 Understanding the FDA's New Guidance: 05:05 Challenges in Supplier Management and the 08:22 Navigating Change Management 11:43 Insi…
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150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar
38:58
38:58
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On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses:00:00 Welcome to Episode 150!03:00 Challenges and Innovations in Ocular Drug Delivery09:30 Understanding Intravitreal Injections13:26 Regulatory Considerations for Ocular Products20:48 Innovations in Glaucoma Treatment29:1…
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149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens
33:11
33:11
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33:11
On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode David discusses:01:01 Recap of the Last Episode01:23 Understanding the Freeze Drying Environment01:46 Freeze Drying Equipment and Processes03:01 Cleaning and Validation in Freeze Drying03:58 Loading an…
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148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner
26:20
26:20
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26:20
On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of standards to medical devices and combination products. Leo delves into the importance of understanding product environment, intended use, and market specifics. …
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147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup
23:15
23:15
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23:15
On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through: David Grosse-Wentrup PhD is a Research Director at Design Science, a global human factors consultancy focused on advancing healthcare technology through user research and design evaluation. After his studies in bi…
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146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens
35:58
35:58
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35:58
On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final steps such as backfilling and stoppering. David also explores the different considerations for lyophilization, the impact of var…
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145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi
40:28
40:28
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40:28
On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reaut…
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144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo
35:36
35:36
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35:36
On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery. David and I discuss: 00:00 Introduction and Guest Overview00:04 David DeSalvo's Career Journey02:13 Understanding Injection Systems04:22 Early Career at BD10:51 Transition to SHL17:50 Starting a New Venture24:54 Experience at …
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143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young
29:22
29:22
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29:22
On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs and Biological Products Guidance for Industry. Industry Comments are DUE 9/29/2024.Alan Stevens is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie wit…
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142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin
30:26
30:26
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30:26
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 01:53 Material Qualification Discussion Begins02:23 Material Qualification in Drugs vs. Devices04:00 Quality Standards in Different Industries08:54 Quality Tools and Their Applications11:22 Material Qualification and Supplier Mana…
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141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)
23:09
23:09
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23:09
On this episode of the Combinate Podcast, I go over 6 lessons from the life and x of H. James Harrington. Dr. H James Harrington has a decorated career with 40 years at IBM, 10 years at Ernst & Young, and has held multiple executive roles at various companies since. He's written more than 55 books on performance improvement. He was the chairman and…
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140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa
30:50
30:50
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30:50
On this episode, I was joined by Christian Espinosa CEO of Blue Goat Cyber. On this episode, Chrsitian walks through:00:00 Introduction and Guest Overview00:20 Christian Espinosa's Journey: From Air Force to Cybersecurity03:41 Medical Device Cybersecurity: Challenges and Risks05:51 Freelance to Entrepreneurship: Founding Blue Goat Cyber07:05 Cybers…
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139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh
27:43
27:43
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27:43
This is a solo episode. On this episode, Subhi goes through: 01:51 Draft FDA Guidance - Platform TechnologyDesignation Program for Drug Development Guidance for Industry 13:03 EMA Guidance - Questions & Answers for applicants, marketing authorisation holders of medicinal products and notifiedbodies with respect to the implementation of theRegulatio…
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138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager
47:34
47:34
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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: 00:31 Larry's Perspective on Quality 03:21 Importance of KPIs in Management Review 04:13 Management Review and Control 09:09 Operational Framework and Business Structure 18:46 Effective Business Processes 24:42 Understanding R…
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137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens
18:11
18:11
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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, Alan walks through: 00:38 Exploring Reliability in Combination Products 01:17 The Importance of Subscribing and Feedback 01:36 Alan Stevens Shares His Expertise 02:40 Understanding Reliability: Definitions and N…
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136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura
39:53
39:53
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39:53
On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through: 00:29 Design Changes When No DHF Exists 03:30 Challenges and Strategies in Document Management 04:49 Improving Design Inputs and Risk Management 21:37 Leveraging Tools for Better Traceability and Compliance Charles Ve…
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135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson
41:16
41:16
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41:16
On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical. On this episode, Anthony discusses: 03:11 The Formation and Impact of the Office of Combination Products 04:16 Challenges and Changes in the Regulatory Landscape for Combination Products 07:53 Understanding FDA Titles and Organizational Struct…
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134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch
41:49
41:49
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41:49
On this episode, I was joined by Richard Koch, Founder of KochSaMD. Richard discusses: 00:29 Exploring Software's Role in Medical Devices 02:29 Deep Dive into Cloud-Based Medical Devices 06:29 The Intricacies of Software Development in Medical Devices 26:33 The Future of Medical Devices in the Cloud Era 32:56 The Potential Impact of Tech Giants on …
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133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell
22:26
22:26
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22:26
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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132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner
31:11
31:11
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31:11
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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131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer
42:53
42:53
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42:53
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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130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder
32:25
32:25
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32:25
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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129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens
32:59
32:59
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32:59
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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128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture
52:32
52:32
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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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127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal
48:25
48:25
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48:25
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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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
35:54
35:54
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35:54
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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125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh
42:04
42:04
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42:04
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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124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson
31:01
31:01
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31:01
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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123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker
45:15
45:15
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45:15
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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122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries
35:59
35:59
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35:59
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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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
33:26
33:26
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33:26
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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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
43:06
43:06
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43:06
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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119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens
26:25
26:25
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26:25
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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118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead
37:53
37:53
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37:53
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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117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano
34:33
34:33
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34:33
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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116 - Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer
39:51
39:51
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39:51
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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115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban
33:35
33:35
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33:35
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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114 - Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer
43:38
43:38
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43:38
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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113 - Pharma/MedTech Market, Why Good People Leave, Finding Motivation, Onshoring in Pharma and Motivation with Ira Mann
28:48
28:48
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28:48
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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112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer
47:26
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47:26
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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111 - 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh
19:59
19:59
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19:59
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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110 - CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin
31:44
31:44
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31:44
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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109 - Protecting Patients at All Costs, Being a CQO in Big Pharma, Supply Chain Security and Generic Drugs with Martin Van Trieste
42:20
42:20
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42:20
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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108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins
38:26
38:26
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38:26
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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107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu
32:20
32:20
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32:20
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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106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott
33:18
33:18
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33:18
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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106 - Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman
32:42
32:42
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32:42
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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