Let's CombinateL Drugs + Devices

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176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski
176 - The Fastest Way to Ruin Drug/Device Development (And How to Avo…
175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau
175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous …
174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin
174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben L…
173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's
173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barrie…
172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead
172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intel…
171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?
171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or …
The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)
The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)
169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective
169 - Should You Study Bioengineering in 2025? My Decade-Long Perspec…
168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth
168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devi…
167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst
167 - Smart Pills, Digital Drug Delivery Systems, and How Technology …
Sync or Sink: 3 Levels of Harmonization for Combination Product Success
Sync or Sink: 3 Levels of Harmonization for Combination Product Succe…
165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New
165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLA…
164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790
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
163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's…
162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)
162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid T…
161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products
161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in M…
160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!
160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!
159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin
159 - Centralized, Decentralized & Federated Quality Models, McKinsey…
158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show
158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Proces…
157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura
157 - Design Inputs that Don't Suck, Risk Control Measures and Proble…
156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar
156 - Combination Product Governance, Big Pharma to Medical Device St…
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
155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led In…
154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell
154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinic…
153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio
153 - USP 382, Elastomeric Component Functional Suitability, Delivery…
152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh
152 - Global Medical Device Podcast Interview: Behind the Combinate P…
151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio
151 - Primary Packaging/Container Closure Change Guidance, Post-Appro…
150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar
150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, G…
149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerationswith David
149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, …
148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner
148 - Standards Applicability Assessments, Atomic Requirements, Docum…
147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup
147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, …
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Recent Blog Posts

Should You Study Bioengineering in 2025? Insights from a Decade in Pharma and Medical Devices
Dec. 31, 2024

Should You Study Bioengineering in 2025? Insights from a Decade in Ph…

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…

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Audits and Self-Improvement: Lesson's From Peter Drucker on Quality in Combination Products, Medical Devices, Pharmaceuticals and Life
Dec. 25, 2024

Audits and Self-Improvement: Lesson's From Peter Drucker on Quality i…

  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 …

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