Recent Episodes
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191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity
Jun 4, 2025 – 00:13:09 -
190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong
May 28, 2025 – 00:15:17 -
189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?
May 21, 2025 – 00:17:14 -
188 – Certified Quality Auditor(CQA) and Audits in the Future
May 14, 2025 – 00:15:39 -
187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)
May 7, 2025 – 00:16:26 -
186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech
Apr 30, 2025 – 00:12:38 -
185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder
Apr 23, 2025 – 00:25:51 -
184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained
Apr 16, 2025 – 00:30:37 -
183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products
Apr 9, 2025 – 00:37:11 -
182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma
Apr 2, 2025 – 00:18:42 -
181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?
Mar 26, 2025 – 00:20:14 -
180 - MIT Leadership Expert Reveals Management Secrets for Scientists!
Mar 19, 2025 – 00:25:18 -
179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing
Mar 12, 2025 – 00:09:27 -
178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know
Mar 5, 2025 – 00:31:22 -
177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED
Feb 26, 2025 – 00:10:58 -
176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski
Feb 19, 2025 – 00:26:20 -
175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau
Feb 12, 2025 – 00:39:49 -
174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin
Feb 5, 2025 – 00:23:57 -
173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's
Jan 29, 2025 – 00:32:58 -
172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead
Jan 22, 2025 – 00:34:19 -
171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?
Jan 13, 2025 – 00:07:59 -
170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)
Jan 8, 2025 – 00:09:43 -
169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective
Jan 1, 2025 – 00:16:36 -
168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth
Dec 25, 2024 – 00:13:21 -
167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst
Dec 18, 2024 – 00:41:13 -
166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success
Dec 11, 2024 – 00:20:51 -
165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New
Dec 4, 2024 – 01:10:41 -
164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790
Nov 27, 2024 – 00:13:15 -
163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle
Nov 20, 2024 – 00:11:19 -
162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)
Nov 12, 2024 – 00:17:43 -
161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products
Nov 6, 2024 – 00:24:09 -
160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!
Oct 30, 2024 – 00:19:07 -
159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin
Oct 23, 2024 – 00:22:24 -
158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show
Oct 16, 2024 – 00:21:23 -
157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura
Oct 9, 2024 – 00:21:30 -
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 2, 2024 – 00:33:01 -
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 – 00:25:25 -
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 – 00:37:31 -
153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio
Sep 11, 2024 – 00:21:56 -
152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh
Sep 4, 2024 – 00:40:48 -
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 – 00:33:38 -
150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar
Aug 21, 2024 – 00:38:58 -
149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens
Aug 14, 2024 – 00:33:11 -
148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner
Aug 7, 2024 – 00:26:20 -
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 – 00:23:15 -
146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens
Jul 24, 2024 – 00:35:58 -
145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi
Jul 17, 2024 – 00:40:28 -
144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo
Jul 10, 2024 – 00:35:36 -
143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young
Jul 3, 2024 – 00:29:22 -
142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin
Jun 26, 2024 – 00:30:26
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