Podd: Let's Combinate - Drugs + Devices

200 - 4 Years of Conversations, and I’m Still Figuring It Out

6 augusti | 17 min

199 - How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall

30 juli | 43 min

198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed

23 juli | 11 min

197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong

16 juli | 14 min

Combi Crumbs: Clinical Trials 101 – From Safety to Strategy

12 juli | 8 min

196 - How to Win Your First 90 Days in Pharma and MedTech

9 juli | 10 min

195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah

2 juli | 48 min

194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer

25 juni | 20 min

193 - Bioengineering Grads: Here’s What Recruiters Actually Want to See in 2025

18 juni | 47 min

192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)

11 juni | 5 min

187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)

7 maj | 16 min

186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech

30 april | 13 min

185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder

23 april | 26 min

184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained

16 april | 31 min

183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products

9 april | 37 min

182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma

2 april | 19 min

181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?

26 mars | 20 min

180 - MIT Leadership Expert Reveals Management Secrets for Scientists!

19 mars | 25 min

179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing

12 mars | 9 min

178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know

5 mars | 31 min

177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED

26 februari | 11 min

176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski

19 februari | 26 min

175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau

12 februari | 40 min

174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin

5 februari | 24 min

173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's

29 januari | 33 min

172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead

22 januari | 34 min

171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?

13 januari | 8 min

170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)

8 januari | 10 min

169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective

1 januari | 17 min

168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth

25 december 2024 | 13 min

167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst

18 december 2024 | 41 min

166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success

11 december 2024 | 21 min

165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New

4 december 2024 | 71 min

164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790

27 november 2024 | 13 min

163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle

20 november 2024 | 11 min

162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)

12 november 2024 | 18 min

161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products

6 november 2024 | 24 min

160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!

30 oktober 2024 | 19 min

159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin

23 oktober 2024 | 22 min

158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show

16 oktober 2024 | 21 min

157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura

9 oktober 2024 | 22 min

156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar

2 oktober 2024 | 33 min

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

25 september 2024 | 25 min

154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell

18 september 2024 | 38 min

153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio

11 september 2024 | 22 min

152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh

4 september 2024 | 41 min

151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio

28 augusti 2024 | 34 min

150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar

21 augusti 2024 | 39 min

149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens

14 augusti 2024 | 33 min

148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner

7 augusti 2024 | 26 min

147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup

30 juli 2024 | 23 min

146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens

24 juli 2024 | 36 min

145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi

17 juli 2024 | 40 min

144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo

10 juli 2024 | 36 min

143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young

3 juli 2024 | 29 min

142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin

26 juni 2024 | 30 min

141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)

19 juni 2024 | 23 min

140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa

12 juni 2024 | 31 min

139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh

5 juni 2024 | 28 min

138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager

29 maj 2024 | 48 min

137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens

22 maj 2024 | 18 min

136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura

15 maj 2024 | 40 min

135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson

8 maj 2024 | 41 min

134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch

1 maj 2024 | 42 min

133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell

24 april 2024 | 22 min

132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner

17 april 2024 | 31 min

131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer

10 april 2024 | 43 min

130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder

3 april 2024 | 32 min

129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens

27 mars 2024 | 33 min

128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture

20 mars 2024 | 53 min

127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal

13 mars 2024 | 48 min

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

6 mars 2024 | 36 min

125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh

28 februari 2024 | 42 min

124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson

21 februari 2024 | 31 min

123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker

14 februari 2024 | 45 min

122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries

7 februari 2024 | 36 min

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

31 januari 2024 | 33 min

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

24 januari 2024 | 43 min

119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens

18 januari 2024 | 26 min

118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead

10 januari 2024 | 38 min

117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano

3 januari 2024 | 35 min

116 - Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer

27 december 2023 | 40 min

115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban

20 december 2023 | 34 min

114 - Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer

13 december 2023 | 44 min

113 - Pharma/MedTech Market, Why Good People Leave, Finding Motivation, Onshoring in Pharma and Motivation with Ira Mann

6 december 2023 | 29 min

112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer

29 november 2023 | 47 min

111 - 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh

22 november 2023 | 20 min

110 - CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin

15 november 2023 | 32 min

109 - Protecting Patients at All Costs, Being a CQO in Big Pharma, Supply Chain Security and Generic Drugs with Martin Van Trieste

8 november 2023 | 42 min

108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins

1 november 2023 | 38 min

107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu

25 oktober 2023 | 32 min

106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott

24 oktober 2023 | 33 min

106 - Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman

11 oktober 2023 | 33 min

105 - Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi Saadeh

4 oktober 2023 | 28 min

104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew

27 september 2023 | 36 min

103 - Prescription Reconciliation, Medication Error Reduction, Automated Home Care, Assisted Robotics, Patient Behavioral Monitoring, and the future of Clinical Trials with Charles Gellman

20 september 2023 | 29 min

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

13 september 2023 | 32 min

101 - Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano

6 september 2023 | 30 min

100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager

30 augusti 2023 | 31 min

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

23 augusti 2023 | 40 min

098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi

16 augusti 2023 | 40 min

097 - Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager

9 augusti 2023 | 43 min

096 - Pharma Waste Management, Sustainability, What Happens to Sharps, Disposal and Zero Waste with Heather Johnson

2 augusti 2023 | 20 min

095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal

26 juli 2023 | 44 min

094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young

19 juli 2023 | 36 min

093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle

12 juli 2023 | 26 min

092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder

5 juli 2023 | 41 min

091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle

28 juni 2023 | 40 min

090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar

21 juni 2023 | 44 min

089 - Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch

14 juni 2023 | 34 min

088 - Production Part Approval Process(PPAP) with Subhi Saadeh

7 juni 2023 | 22 min

087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque

31 maj 2023 | 40 min

086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with ⁠Fran DeGrazio⁠

24 maj 2023 | 31 min

085 - Digital Innovation, Proteomics, Core & Non-Core Innovation, Consulting after Academia, Democratizing Access and Clinical Trials with Jacob Laprote

17 maj 2023 | 36 min

084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New

10 maj 2023 | 51 min

083 - Holistic Approach to Container Closure Integrity, Capping/Crimping, RSF, and Annex I/USP 1207 Requirements with Derek Duncan

3 maj 2023 | 27 min

082 - CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R with Niedre Heckman

26 april 2023 | 44 min

081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt

19 april 2023 | 48 min

080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan

12 april 2023 | 25 min

079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young

5 april 2023 | 35 min

078 - Prevention is Not New, Incentives in Health Care, and Integrated Combination Products with Ramin Rafiei

29 mars 2023 | 42 min

077 - 8 Databases and How To Use Them with Michelle Lott

22 mars 2023 | 23 min

076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant

15 mars 2023 | 28 min

075 - Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin

8 mars 2023 | 34 min

074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman

1 mars 2023 | 28 min

073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal

22 februari 2023 | 19 min

072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa

15 februari 2023 | 54 min

071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols

8 februari 2023 | 59 min

070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen

1 februari 2023 | 51 min

069 - EU MDR Extension with Michelle Lott

25 januari 2023 | 18 min

068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge

18 januari 2023 | 47 min

067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True

11 januari 2023 | 48 min

066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio

4 januari 2023 | 56 min

065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh

28 december 2022 | 29 min

064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling

21 december 2022 | 55 min

063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman

14 december 2022 | 48 min

062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer

7 december 2022 | 37 min

061 - Taguchi, Pugh, DFSS, Robust Design and Tolerancing with Skip Creveling

30 november 2022 | 45 min

060 - Why People Leave, Starting Elemed and Trusted Advisory with Elena Kyria

23 november 2022 | 42 min

059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower

16 november 2022 | 41 min

058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano

9 november 2022 | 44 min

057 - Conferences, Expos, LinkedIn and Launching a Podcast with Rizwan Chaudhrey

2 november 2022 | 46 min

056 - "Non-Promotional Compliance" with Darshan Kulkarni

26 oktober 2022 | 34 min

055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis

19 oktober 2022 | 51 min

054 - "EUDAMED" with Richard Houlihan

12 oktober 2022 | 29 min

053 - "Duct Tape and Bubble Gum" with Chris Tsai

5 oktober 2022 | 65 min

052 - “All Work is Process” with Larry Mager

28 september 2022 | 54 min

051 - "EU MDR" with Bassil Akra

21 september 2022 | 45 min

050 - "When No One is Listening" with James Somauroo

14 september 2022 | 41 min

049 - "What Does the Data Say?" with Shannon Hoste

7 september 2022 | 46 min

048 - "Materials" with Hsinjin Yang

31 augusti 2022 | 35 min

047 - "Truthful Not Misleading" with Darshan Kulkarni

24 augusti 2022 | 60 min

046 - "Inflation Reduction Act" with Sarfaraz Niazi

17 augusti 2022 | 32 min

045 - "Combination Products around the Globe" with Susan Neadle

10 augusti 2022 | 36 min

044 -“Market Access” with Kasem Akhras

3 augusti 2022 | 74 min

043 - “Half Knowledge Can Hurt” with Shadeed Salam

27 juli 2022 | 74 min

042 - “Reproducible within Limits”

20 juli 2022 | 20 min

041 - “Health Citizenship” with Jane Sarasohn Kahn

13 juli 2022 | 70 min

040 - “Good Science is Good Science” with Ben Locwin

6 juli 2022 | 50 min

039 - "The Camera Didn't Make the Artist Obsolete" with John Nosta

29 juni 2022 | 65 min

038 - "Clinical Trials" with Dan Sfera

22 juni 2022 | 74 min

037 - Reflections #1 - (Episodes 001-25)

15 juni 2022 | 34 min

036 - "Those Moments Keep You Grounded" with Yousef Arman

8 juni 2022 | 43 min

035 - “Safety is Safety” with Khaudeja Bano

1 juni 2022 | 48 min

034 - "Agent" with Mitch Robbins

25 maj 2022 | 55 min

033 - "Specialization" with Erik Barkley

18 maj 2022 | 71 min

032 - “Quality is Free”

11 maj 2022 | 24 min

031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

4 maj 2022 | 79 min

030 - "Why Don't I Try?" with Marc Koska

27 april 2022 | 98 min

029 - "Purpose" with Marla Phillips

20 april 2022 | 94 min

028 - "How Much Does Poor Quality Cost?" with H. James Harrington

13 april 2022 | 71 min

027 - "Become a Historian of the Problem" with Duane Mancini

6 april 2022 | 59 min

026 - "Quality" with H. James Harrington

30 mars 2022 | 50 min

025 - “The Frying Pan to the Fire” with Edwin Bills

23 mars 2022 | 91 min

024 - "Operating Under Constraints "with Naveen Agarwal

16 mars 2022 | 73 min

023 - "The Best is Yet to Come" with David Albert

9 mars 2022 | 67 min

022 - "What Chapter are you in?" with Susan Neadle

2 mars 2022 | 83 min

021 - "Options" with Karandeep Singh Badwal

23 februari 2022 | 63 min

020- "The Right Words" with Kathy Walsh

16 februari 2022 | 103 min

019 - "Carrying The Bag" with Omar M Khateeb

9 februari 2022 | 92 min

018 - "The Optimist Plans for Forever" - with Sarfaraz Niazi

2 februari 2022 | 89 min

017 - "Feet First" with Ahmed Zobi

26 januari 2022 | 68 min

016 - "Be More Specific" with Joe Hage

19 januari 2022 | 50 min

015 - "Would You Use it on a Family Member?" with Monir El Azzouzi

19 januari 2022 | 89 min

014A - "The First P: Product" with Larry Mager

5 januari 2022 | 72 min

014B - "The Second P: Process" with Larry Mager

5 januari 2022 | 51 min

014C - "The Final P: People" with Larry Mager

5 januari 2022 | 50 min

013 - “Big Rocks and Little Rocks” with Jumha Abu-Razeq

29 december 2021 | 62 min

012 - "Asking then Seeing" with Sara Waxberg Mcnew

22 december 2021 | 76 min

011 - “Long Story Short” with Margot Leitman

15 december 2021 | 79 min

010 - "Don't Make Assumptions" with David Simoens

8 december 2021 | 74 min

009 - “Cutting Through the Noise” with Charles Ventura

1 december 2021 | 91 min

008 - "Follow the Opportunity" with Marta New

24 november 2021 | 55 min

007 - "Beyond The Obvious" with Miiri Kotche

17 november 2021 | 52 min

006 - “The Courage to Start” with John Bingham

10 november 2021 | 63 min

005 - “Compassionate Product Development” with Cameron Jones

3 november 2021 | 59 min

004 - “Until They Know How Much You Care” with Andy Robertson

27 oktober 2021 | 62 min

003 - “Standard Understanding” with Mark Swanson

20 oktober 2021 | 54 min

002 - “Seeing David in the Stone: Predictive Quality Management” with Larry Mager

14 oktober 2021 | 58 min

001 - “Learning Never Exhausts the Mind” with Rick Doe

6 oktober 2021 | 89 min

Let’s Combinate – Drugs + Devices

Avsnitt

200 - 4 Years of Conversations, and I’m Still Figuring It Out

199 - How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall

198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed

197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong

Combi Crumbs: Clinical Trials 101 – From Safety to Strategy

196 - How to Win Your First 90 Days in Pharma and MedTech

195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah

194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer

193 - Bioengineering Grads: Here’s What Recruiters Actually Want to See in 2025

192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)

191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity

190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong

189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?

188 – Certified Quality Auditor(CQA) and Audits in the Future

187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)

186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech

185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder

184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained

183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products

182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma

181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?

180 - MIT Leadership Expert Reveals Management Secrets for Scientists!

179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing

178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know

177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED

176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski

175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau

174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin

173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's

172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead

171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?

170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)

169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective

168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth

167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst

166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success

165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New

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

162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)

161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products

160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!

159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin

158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show

157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura

156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar

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

154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell

153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio

152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh

151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio

150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar

149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens

148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner

147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup

146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens

145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi

144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo

143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young

142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin

141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)

140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa

139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh

138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager

137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens

136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura

135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson

134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch

133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell

132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner

131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer

130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder

129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens

128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture

127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal

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

125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh

124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson