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171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?
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The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)
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169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective
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168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth
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167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst
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Sync or Sink: 3 Levels of Harmonization for Combination Product Success
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165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New
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164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790
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163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle
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162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)
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161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products
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160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!
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159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin
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158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show
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157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura
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156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar
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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
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154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell
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153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio
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152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh
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151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio
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150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar
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149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerationswith David
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148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner
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147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup
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146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens
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Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi
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144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo
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143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young
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142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin
Episode pageRecent Blog Posts
Should You Study Bioengineering in 2025? Insights from a Decade in Pharma and Medical Devices
Choosing a college major is one of the most significant decisions you’ll make in shaping your future career. For many, bioengineering stands out as a promising path, blending cutting-edge innovation with the potential to make a meaningful impa…
Audits and Self-Improvement: Lesson's From Peter Drucker on Quality in Combination Products, Medical Devices, Pharmaceuticals and Life
In this episode of Let’s ComBinate, we dive into the fascinating world of audits—a cornerstone activity for ensuring quality, compliance, and continuous improvement across industries. Whether you’re …