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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143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young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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47:34
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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18:11
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
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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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52:32
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
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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
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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
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
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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
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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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105 - Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi Saadeh
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27:50
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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104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew
36:29
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36:29
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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103 - Prescription Reconciliation, Medication Error Reduction, Automated Home Care, Assisted Robotics, Patient Behavioral Monitoring, and the future of Clinical Trials with Charles Gellman
29:10
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29:10
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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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
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32:27
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32:27
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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101 - Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano
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29:34
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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100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager
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30:30
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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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
40:17
40:17
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40:17
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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098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi
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40:04
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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097 - Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager
43:16
43:16
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43:16
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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096 - Pharma Waste Management, Sustainability, What Happens to Sharps, Disposal and Zero Waste with Heather Johnson
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20:12
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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095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal
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43:32
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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