Let's Combinate - Drugs + Devices
By Subhi Saadeh
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Episodes: 256
Description
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!
| Episode | Date |
|---|---|
|
249 - The Best Audit Advice Nobody Told Me
|
Aug 05, 2026 |
|
248 - What Is a Quality Unit? QA vs. QC Explained
|
Jul 29, 2026 |
|
247 - Why Everyone in Pharma and MedTech Should Work in Quality
|
Jul 22, 2026 |
|
246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)
|
Jul 15, 2026 |
|
245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector
|
Jul 08, 2026 |
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244 - 5 Critical Quality Differences Between Drugs and Devices
|
Jul 01, 2026 |
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243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work
|
Jun 24, 2026 |
|
242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start
|
Jun 17, 2026 |
|
241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?
|
Jun 10, 2026 |
|
240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy
|
Jun 03, 2026 |
|
239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes
|
May 27, 2026 |
|
239 - ICH Q11 in 6 Minutes
|
May 20, 2026 |
|
238 - 6 Audit Strategies Every Auditor Should Know
|
May 13, 2026 |
|
237 - ICH Q10: The Pharmaceutical Quality System
|
May 06, 2026 |
|
236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences
|
Apr 29, 2026 |
|
235 - ICH Q8: How Pharmaceutical Development Actually Works
|
Apr 22, 2026 |
|
234 - ICH Q7: The GMP Framework for API Manufacturing
|
Apr 15, 2026 |
|
233 - Most Teams Misunderstand Specifications | ICH Q6
|
Apr 08, 2026 |
|
232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk
|
Apr 01, 2026 |
|
231 - Audit Findings Explained: Nonconformity vs Observation (CQA)
|
Mar 25, 2026 |
|
230 - How Pharma Misses Critical Market Signals with Joe Luminiello
|
Mar 23, 2026 |
|
229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products
|
Mar 11, 2026 |
|
228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently
|
Mar 04, 2026 |
|
227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics
|
Feb 24, 2026 |
|
226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification
|
Feb 18, 2026 |
|
226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions
|
Feb 11, 2026 |
|
225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes
|
Feb 04, 2026 |
|
224 - ICH Q2 Explained: What Analytical Validation Really Requires
|
Jan 28, 2026 |
|
223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations
|
Jan 21, 2026 |
|
222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series
|
Jan 14, 2026 |
|
221 - What Is ICH and Why It Matters
|
Jan 07, 2026 |
|
220 - Managing Oneself, Reflections and a New Series on ICH
|
Dec 31, 2025 |
|
219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness
|
Dec 24, 2025 |
|
218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)
|
Dec 17, 2025 |
|
217 - 5 Fixable Problems Holding Back Drug–Device Programs
|
Dec 10, 2025 |
|
216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke
|
Dec 03, 2025 |
|
215 - Why Aren’t Technical People Leading Drug-Device Audits?
|
Nov 26, 2025 |
|
214 - The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More)
|
Nov 19, 2025 |
|
213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site
|
Nov 12, 2025 |
|
212 - What 6 of the World’s Biggest Companies Taught Him About Combination Products
|
Nov 05, 2025 |
|
211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer
|
Oct 30, 2025 |
|
210 - The 8 Roles You MUST Understand in Pharma & MedTech
|
Oct 22, 2025 |
|
210 - How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield
|
Oct 15, 2025 |
|
209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos
|
Oct 08, 2025 |
|
208 - How Drugs Are Designed, Targets, Phenotypes, and Structure Based Design
|
Oct 01, 2025 |
|
207 - What 99.999% Reliability Really Means
|
Sep 24, 2025 |
|
206 - Will AI Decide Your Next Drug/Device Approval?
|
Sep 17, 2025 |
|
205 - Why Less Than 20% of Companies Have Started Quality 4.0
|
Sep 11, 2025 |
|
204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle
|
Sep 03, 2025 |
|
203 - Drug Delivery, Platforms, IP Battles, Supply Chain Risks with Jim Collins
|
Aug 27, 2025 |
|
202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin
|
Aug 20, 2025 |
|
201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0
|
Aug 13, 2025 |
|
200 - MedTech and Pharma After 200 Episodes…..
|
Aug 06, 2025 |
|
199 - How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall
|
Jul 30, 2025 |
|
198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed
|
Jul 23, 2025 |
|
197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong
|
Jul 16, 2025 |
|
Combi Crumbs: Clinical Trials 101 – From Safety to Strategy
|
Jul 12, 2025 |
|
196 - How to Win Your First 90 Days in Pharma and MedTech
|
Jul 09, 2025 |
|
195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah
|
Jul 02, 2025 |
|
194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer
|
Jun 25, 2025 |
|
193 - Bioengineering Grads: Here’s What Recruiters Actually Want to See in 2025
|
Jun 18, 2025 |
|
192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)
|
Jun 11, 2025 |
|
191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity
|
Jun 04, 2025 |
|
190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong
|
May 28, 2025 |
|
189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?
|
May 21, 2025 |
|
188 – Certified Quality Auditor(CQA) and Audits in the Future
|
May 14, 2025 |
|
187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)
|
May 07, 2025 |
|
186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech
|
Apr 30, 2025 |
|
185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder
|
Apr 23, 2025 |
|
184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained
|
Apr 16, 2025 |
|
183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products
|
Apr 09, 2025 |
|
182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma
|
Apr 02, 2025 |
|
181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?
|
Mar 26, 2025 |
|
180 - MIT Leadership Expert Reveals Management Secrets for Scientists!
|
Mar 19, 2025 |
|
179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing
|
Mar 12, 2025 |
|
178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know
|
Mar 05, 2025 |
|
177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED
|
Feb 26, 2025 |
|
176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski
|
Feb 19, 2025 |
|
175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau
|
Feb 12, 2025 |
|
174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin
|
Feb 05, 2025 |
|
173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's
|
Jan 29, 2025 |
|
172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead
|
Jan 22, 2025 |
|
171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?
|
Jan 13, 2025 |
|
170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)
|
Jan 08, 2025 |
|
169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective
|
Jan 01, 2025 |
|
168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth
|
Dec 25, 2024 |
|
167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst
|
Dec 18, 2024 |
|
166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success
|
Dec 11, 2024 |
|
165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New
|
Dec 04, 2024 |
|
164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790
|
Nov 27, 2024 |
|
163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle
|
Nov 20, 2024 |
|
162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)
|
Nov 12, 2024 |
|
161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products
|
Nov 06, 2024 |
|
160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!
|
Oct 30, 2024 |
|
159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin
|
Oct 23, 2024 |
|
158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show
|
Oct 16, 2024 |
|
157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura
|
Oct 09, 2024 |
|
156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar
|
Oct 02, 2024 |
|
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
|
Sep 25, 2024 |
|
154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell
|
Sep 18, 2024 |
|
153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio
|
Sep 11, 2024 |
|
152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh
|
Sep 04, 2024 |
|
151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio
|
Aug 28, 2024 |
|
150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar
|
Aug 21, 2024 |
|
149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens
|
Aug 14, 2024 |
|
148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner
|
Aug 07, 2024 |
|
147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup
|
Jul 30, 2024 |
|
146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens
|
Jul 24, 2024 |
|
145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi
|
Jul 17, 2024 |
|
144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo
|
Jul 10, 2024 |
|
143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young
|
Jul 03, 2024 |
|
142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin
|
Jun 26, 2024 |
|
141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)
|
Jun 19, 2024 |
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140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa
|
Jun 12, 2024 |
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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
|
Jun 05, 2024 |
|
138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager
|
May 29, 2024 |
|
137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens
|
May 22, 2024 |
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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
|
May 15, 2024 |
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135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson
|
May 08, 2024 |
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134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch
|
May 01, 2024 |
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133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell
|
Apr 24, 2024 |
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132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner
|
Apr 17, 2024 |
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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
|
Apr 10, 2024 |
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130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder
|
Apr 03, 2024 |
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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
|
Mar 27, 2024 |
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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
|
Mar 20, 2024 |
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127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal
|
Mar 13, 2024 |
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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
|
Mar 06, 2024 |
|
125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh
|
Feb 28, 2024 |
|
124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson
|
Feb 21, 2024 |
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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
|
Feb 14, 2024 |
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122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries
|
Feb 07, 2024 |
|
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
|
Jan 31, 2024 |
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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
|
Jan 24, 2024 |
|
119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens
|
Jan 18, 2024 |
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118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead
|
Jan 10, 2024 |
|
117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano
|
Jan 03, 2024 |
|
116 - Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer
|
Dec 27, 2023 |
|
115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban
|
Dec 20, 2023 |
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114 - Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer
|
Dec 13, 2023 |
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113 - Pharma/MedTech Market, Why Good People Leave, Finding Motivation, Onshoring in Pharma and Motivation with Ira Mann
|
Dec 06, 2023 |
|
112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer
|
Nov 29, 2023 |
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111 - 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh
|
Nov 22, 2023 |
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110 - CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin
|
Nov 15, 2023 |
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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
|
Nov 08, 2023 |
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108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins
|
Nov 01, 2023 |
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107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu
|
Oct 25, 2023 |
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106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott
|
Oct 24, 2023 |
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106 - Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman
|
Oct 11, 2023 |
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105 - Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi Saadeh
|
Oct 04, 2023 |
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104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew
|
Sep 27, 2023 |
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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
|
Sep 20, 2023 |
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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
|
Sep 13, 2023 |
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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
|
Sep 06, 2023 |
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100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager
|
Aug 30, 2023 |
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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
|
Aug 23, 2023 |
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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
|
Aug 16, 2023 |
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097 - Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager
|
Aug 09, 2023 |
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096 - Pharma Waste Management, Sustainability, What Happens to Sharps, Disposal and Zero Waste with Heather Johnson
|
Aug 02, 2023 |
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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
|
Jul 26, 2023 |
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094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young
|
Jul 19, 2023 |
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093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle
|
Jul 12, 2023 |
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092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder
|
Jul 05, 2023 |
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091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle
|
Jun 28, 2023 |
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090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar
|
Jun 21, 2023 |
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089 - Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch
|
Jun 14, 2023 |
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088 - Production Part Approval Process(PPAP) with Subhi Saadeh
|
Jun 07, 2023 |
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087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque
|
May 31, 2023 |
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086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with Fran DeGrazio
|
May 24, 2023 |
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085 - Digital Innovation, Proteomics, Core & Non-Core Innovation, Consulting after Academia, Democratizing Access and Clinical Trials with Jacob Laprote
|
May 17, 2023 |
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084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New
|
May 10, 2023 |
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083 - Holistic Approach to Container Closure Integrity, Capping/Crimping, RSF, and Annex I/USP 1207 Requirements with Derek Duncan
|
May 03, 2023 |
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082 - CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R with Niedre Heckman
|
Apr 26, 2023 |
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081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt
|
Apr 19, 2023 |
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080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan
|
Apr 12, 2023 |
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079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young
|
Apr 05, 2023 |
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078 - Prevention is Not New, Incentives in Health Care, and Integrated Combination Products with Ramin Rafiei
|
Mar 29, 2023 |
|
077 - 8 Databases and How To Use Them with Michelle Lott
|
Mar 22, 2023 |
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076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant
|
Mar 15, 2023 |
|
075 - Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin
|
Mar 08, 2023 |
|
074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman
|
Mar 01, 2023 |
|
073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal
|
Feb 22, 2023 |
|
072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa
|
Feb 15, 2023 |
|
071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols
|
Feb 08, 2023 |
|
070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen
|
Feb 01, 2023 |
|
069 - EU MDR Extension with Michelle Lott
|
Jan 25, 2023 |
|
068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge
|
Jan 18, 2023 |
|
067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True
|
Jan 11, 2023 |
|
066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio
|
Jan 04, 2023 |
|
065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh
|
Dec 28, 2022 |
|
064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling
|
Dec 21, 2022 |
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063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman
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Dec 14, 2022 |
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062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer
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Dec 07, 2022 |
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061 - Taguchi, Pugh, DFSS, Robust Design and Tolerancing with Skip Creveling
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Nov 30, 2022 |
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060 - Why People Leave, Starting Elemed and Trusted Advisory with Elena Kyria
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Nov 23, 2022 |
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059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower
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Nov 16, 2022 |
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058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano
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Nov 09, 2022 |
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057 - Conferences, Expos, LinkedIn and Launching a Podcast with Rizwan Chaudhrey
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Nov 02, 2022 |
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056 - "Non-Promotional Compliance" with Darshan Kulkarni
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Oct 26, 2022 |
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055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis
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Oct 19, 2022 |
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054 - "EUDAMED" with Richard Houlihan
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Oct 12, 2022 |
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053 - "Duct Tape and Bubble Gum" with Chris Tsai
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Oct 05, 2022 |
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052 - “All Work is Process” with Larry Mager
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Sep 28, 2022 |
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051 - "EU MDR" with Bassil Akra
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Sep 21, 2022 |
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050 - "When No One is Listening" with James Somauroo
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Sep 14, 2022 |
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049 - "What Does the Data Say?" with Shannon Hoste
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Sep 07, 2022 |
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048 - "Materials" with Hsinjin Yang
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Aug 31, 2022 |
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047 - "Truthful Not Misleading" with Darshan Kulkarni
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Aug 24, 2022 |
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046 - "Inflation Reduction Act" with Sarfaraz Niazi
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Aug 17, 2022 |
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045 - "Combination Products around the Globe" with Susan Neadle
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Aug 10, 2022 |
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044 -“Market Access” with Kasem Akhras
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Aug 03, 2022 |
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043 - “Half Knowledge Can Hurt” with Shadeed Salam
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Jul 27, 2022 |
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042 - “Reproducible within Limits”
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Jul 20, 2022 |
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041 - “Health Citizenship” with Jane Sarasohn Kahn
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Jul 13, 2022 |
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040 - “Good Science is Good Science” with Ben Locwin
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Jul 06, 2022 |
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039 - "The Camera Didn't Make the Artist Obsolete" with John Nosta
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Jun 29, 2022 |
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038 - "Clinical Trials" with Dan Sfera
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Jun 22, 2022 |
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037 - Reflections #1 - (Episodes 001-25)
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Jun 15, 2022 |
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036 - "Those Moments Keep You Grounded" with Yousef Arman
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Jun 08, 2022 |
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035 - “Safety is Safety” with Khaudeja Bano
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Jun 01, 2022 |
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034 - "Agent" with Mitch Robbins
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May 25, 2022 |
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033 - "Specialization" with Erik Barkley
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May 18, 2022 |
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032 - “Quality is Free”
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May 11, 2022 |
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031 - "The Five Stages Of Regulatory Grief" with Michelle Lott
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May 04, 2022 |
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030 - "Why Don't I Try?" with Marc Koska
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Apr 27, 2022 |
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029 - "Purpose" with Marla Phillips
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Apr 20, 2022 |
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028 - "How Much Does Poor Quality Cost?" with H. James Harrington
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Apr 13, 2022 |
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027 - "Become a Historian of the Problem" with Duane Mancini
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Apr 06, 2022 |
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026 - "Quality" with H. James Harrington
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Mar 30, 2022 |
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025 - “The Frying Pan to the Fire” with Edwin Bills
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Mar 23, 2022 |
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024 - "Operating Under Constraints "with Naveen Agarwal
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Mar 16, 2022 |
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023 - "The Best is Yet to Come" with David Albert
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Mar 09, 2022 |
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022 - "What Chapter are you in?" with Susan Neadle
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Mar 02, 2022 |
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021 - "Options" with Karandeep Singh Badwal
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Feb 23, 2022 |
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020- "The Right Words" with Kathy Walsh
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Feb 16, 2022 |
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019 - "Carrying The Bag" with Omar M Khateeb
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Feb 09, 2022 |
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018 - "The Optimist Plans for Forever" - with Sarfaraz Niazi
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Feb 02, 2022 |
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017 - "Feet First" with Ahmed Zobi
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Jan 26, 2022 |
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016 - "Be More Specific" with Joe Hage
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Jan 19, 2022 |
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015 - "Would You Use it on a Family Member?" with Monir El Azzouzi
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Jan 19, 2022 |
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014A - "The First P: Product" with Larry Mager
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Jan 05, 2022 |
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014B - "The Second P: Process" with Larry Mager
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Jan 05, 2022 |
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014C - "The Final P: People" with Larry Mager
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Jan 05, 2022 |
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013 - “Big Rocks and Little Rocks” with Jumha Abu-Razeq
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Dec 29, 2021 |
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012 - "Asking then Seeing" with Sara Waxberg Mcnew
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Dec 22, 2021 |
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011 - “Long Story Short” with Margot Leitman
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Dec 15, 2021 |
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010 - "Don't Make Assumptions" with David Simoens
|
Dec 08, 2021 |
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009 - “Cutting Through the Noise” with Charles Ventura
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Dec 01, 2021 |
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008 - "Follow the Opportunity" with Marta New
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Nov 24, 2021 |
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007 - "Beyond The Obvious" with Miiri Kotche
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Nov 17, 2021 |
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006 - “The Courage to Start” with John Bingham
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Nov 10, 2021 |
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005 - “Compassionate Product Development” with Cameron Jones
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Nov 03, 2021 |
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004 - “Until They Know How Much You Care” with Andy Robertson
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Oct 27, 2021 |
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003 - “Standard Understanding” with Mark Swanson
|
Oct 20, 2021 |
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002 - “Seeing David in the Stone: Predictive Quality Management” with Larry Mager
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Oct 14, 2021 |
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001 - “Learning Never Exhausts the Mind” with Rick Doe
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Oct 06, 2021 |