All Episodes
Let's Combinate - Drugs + Devices — 244 episodes
238 - 6 Audit Strategies Every Auditor Should Know
237 - ICH Q10: The Pharmaceutical Quality System
236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences
235 - ICH Q8: How Pharmaceutical Development Actually Works
234 - ICH Q7: The GMP Framework for API Manufacturing
233 - Most Teams Misunderstand Specifications | ICH Q6
232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk
231 - Audit Findings Explained: Nonconformity vs Observation (CQA)
230 - How Pharma Misses Critical Market Signals with Joe Luminiello
229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products
228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently
227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics
226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification
226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions
225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes
224 - ICH Q2 Explained: What Analytical Validation Really Requires
223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations
222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series
221 - What Is ICH and Why It Matters
220 - Managing Oneself, Reflections and a New Series on ICH
219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness
218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)
217 - 5 Fixable Problems Holding Back Drug–Device Programs
216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke
215 - Why Aren’t Technical People Leading Drug-Device Audits?
214 - The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More)
213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site
212 - What 6 of the World’s Biggest Companies Taught Him About Combination Products
211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer
210 - The 8 Roles You MUST Understand in Pharma & MedTech
210 - How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield
209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos
208 - How Drugs Are Designed, Targets, Phenotypes, and Structure Based Design
207 - What 99.999% Reliability Really Means
206 - Will AI Decide Your Next Drug/Device Approval?
205 - Why Less Than 20% of Companies Have Started Quality 4.0
204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle
203 - Drug Delivery, Platforms, IP Battles, Supply Chain Risks with Jim Collins
202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin
201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0
200 - MedTech and Pharma After 200 Episodes…..
199 - How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall
198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed
197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong
Combi Crumbs: Clinical Trials 101 – From Safety to Strategy
196 - How to Win Your First 90 Days in Pharma and MedTech
195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah
194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer
193 - Bioengineering Grads: Here’s What Recruiters Actually Want to See in 2025
192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)
191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity
190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong
189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?
188 – Certified Quality Auditor(CQA) and Audits in the Future
187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)
186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech
185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder
184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained
183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products
182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma
181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?
180 - MIT Leadership Expert Reveals Management Secrets for Scientists!
179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing
178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know
177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED
176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski
175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau
174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin
173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's
172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead
171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?
170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)
169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective
168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth
167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst
166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success
165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New
164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790
163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle
162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)
161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products
160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!
159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin
158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show
157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura
156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar
155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach
154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell
153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio
152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh
151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio
150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar
149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens
148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner
147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup
146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens
145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi
144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo
143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young
142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin
141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)
140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa
139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh
138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager
137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens
136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura
135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson
134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch
133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell
132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner
131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer
130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder
129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens
128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture
127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal
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
125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh
124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson
123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker
122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries
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
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
119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens
118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead
117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano
116 - Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer
115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban
114 - Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer
113 - Pharma/MedTech Market, Why Good People Leave, Finding Motivation, Onshoring in Pharma and Motivation with Ira Mann
112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer
111 - 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh
110 - CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin
109 - Protecting Patients at All Costs, Being a CQO in Big Pharma, Supply Chain Security and Generic Drugs with Martin Van Trieste
108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins
107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu
106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott
106 - Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman
105 - Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi Saadeh
104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew
103 - Prescription Reconciliation, Medication Error Reduction, Automated Home Care, Assisted Robotics, Patient Behavioral Monitoring, and the future of Clinical Trials with Charles Gellman
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
101 - Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano
100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager
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
098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi
097 - Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager
096 - Pharma Waste Management, Sustainability, What Happens to Sharps, Disposal and Zero Waste with Heather Johnson
095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal
094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young
093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle
092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder
091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle
090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar
089 - Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch
088 - Production Part Approval Process(PPAP) with Subhi Saadeh
087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque
086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with Fran DeGrazio
085 - Digital Innovation, Proteomics, Core & Non-Core Innovation, Consulting after Academia, Democratizing Access and Clinical Trials with Jacob Laprote
084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New
083 - Holistic Approach to Container Closure Integrity, Capping/Crimping, RSF, and Annex I/USP 1207 Requirements with Derek Duncan
082 - CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R with Niedre Heckman
081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt
080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan
079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young
078 - Prevention is Not New, Incentives in Health Care, and Integrated Combination Products with Ramin Rafiei
077 - 8 Databases and How To Use Them with Michelle Lott
076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant
075 - Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin
074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman
073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal
072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa
071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols
070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen
069 - EU MDR Extension with Michelle Lott
068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge
067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True
066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio
065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh
064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling
063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman
062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer
061 - Taguchi, Pugh, DFSS, Robust Design and Tolerancing with Skip Creveling
060 - Why People Leave, Starting Elemed and Trusted Advisory with Elena Kyria
059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower
058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano
057 - Conferences, Expos, LinkedIn and Launching a Podcast with Rizwan Chaudhrey
056 - "Non-Promotional Compliance" with Darshan Kulkarni
055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis
054 - "EUDAMED" with Richard Houlihan
053 - "Duct Tape and Bubble Gum" with Chris Tsai
052 - “All Work is Process” with Larry Mager
051 - "EU MDR" with Bassil Akra
050 - "When No One is Listening" with James Somauroo
049 - "What Does the Data Say?" with Shannon Hoste
048 - "Materials" with Hsinjin Yang
047 - "Truthful Not Misleading" with Darshan Kulkarni
046 - "Inflation Reduction Act" with Sarfaraz Niazi
045 - "Combination Products around the Globe" with Susan Neadle
044 -“Market Access” with Kasem Akhras
043 - “Half Knowledge Can Hurt” with Shadeed Salam
042 - “Reproducible within Limits”
041 - “Health Citizenship” with Jane Sarasohn Kahn
040 - “Good Science is Good Science” with Ben Locwin
039 - "The Camera Didn't Make the Artist Obsolete" with John Nosta
038 - "Clinical Trials" with Dan Sfera
037 - Reflections #1 - (Episodes 001-25)
036 - "Those Moments Keep You Grounded" with Yousef Arman
035 - “Safety is Safety” with Khaudeja Bano
034 - "Agent" with Mitch Robbins
033 - "Specialization" with Erik Barkley
032 - “Quality is Free”
031 - "The Five Stages Of Regulatory Grief" with Michelle Lott
030 - "Why Don't I Try?" with Marc Koska
029 - "Purpose" with Marla Phillips
028 - "How Much Does Poor Quality Cost?" with H. James Harrington
027 - "Become a Historian of the Problem" with Duane Mancini
026 - "Quality" with H. James Harrington
025 - “The Frying Pan to the Fire” with Edwin Bills
024 - "Operating Under Constraints "with Naveen Agarwal
023 - "The Best is Yet to Come" with David Albert
022 - "What Chapter are you in?" with Susan Neadle
021 - "Options" with Karandeep Singh Badwal
020- "The Right Words" with Kathy Walsh
019 - "Carrying The Bag" with Omar M Khateeb
018 - "The Optimist Plans for Forever" - with Sarfaraz Niazi
017 - "Feet First" with Ahmed Zobi
016 - "Be More Specific" with Joe Hage
015 - "Would You Use it on a Family Member?" with Monir El Azzouzi
014C - "The Final P: People" with Larry Mager
014B - "The Second P: Process" with Larry Mager
014A - "The First P: Product" with Larry Mager
013 - “Big Rocks and Little Rocks” with Jumha Abu-Razeq
012 - "Asking then Seeing" with Sara Waxberg Mcnew
011 - “Long Story Short” with Margot Leitman
010 - "Don't Make Assumptions" with David Simoens
009 - “Cutting Through the Noise” with Charles Ventura
008 - "Follow the Opportunity" with Marta New
007 - "Beyond The Obvious" with Miiri Kotche
006 - “The Courage to Start” with John Bingham
005 - “Compassionate Product Development” with Cameron Jones
004 - “Until They Know How Much You Care” with Andy Robertson
003 - “Standard Understanding” with Mark Swanson
002 - “Seeing David in the Stone: Predictive Quality Management” with Larry Mager
001 - “Learning Never Exhausts the Mind” with Rick Doe