Combinate Podcast - Combining Drugs and Devices

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Hello Combi-Nation!Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!

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Recent Episodes
  • 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
Recent Reviews
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