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191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity
Manage episode 486803281 series 3325357
You’ve heard it before: If it’s not documented, it didn’t happen. But in life sciences, documentation isn’t just a formality—it’s the foundation of trust, compliance, and product quality. In this episode, Subhi Saadeh breaks down what documentation actually means by exploring the principles of ALCOA and ALCOA+.Learn where these principles come from, how they’re applied, and why they still matter—even in today's digital systems. From FDA guidances to $500M data scandals, this episode covers what goes wrong when data integrity isn’t taken seriously.⏱️ Timestamps:00:00 – Introduction: Why Documentation Still Matters01:24 – Defining Data Integrity in Regulated Industries03:06 – ALCOA Explained: Attributable, Legible, Contemporaneous, Original, Accurate07:18 – ALCOA Plus: Complete, Consistent, Enduring, Available08:54 – Real-World Examples: From Whiteout to Warning Letters11:00 – Why Old SOPs Can Ruin New Inspections12:21 – Final Thoughts: Documentation Is About Trust, Not Just Compliance🔍 What You’ll Learn:How ALCOA originated in the 1990s FDA frameworkWhy banning whiteout in labs is about more than inkThe difference between original vs. accurate vs. complete dataHow legacy documentation can break inspectionsThe role of tribal knowledge in document managementThe limits of electronic systems without strong governanceWhy AI and searchability are the next frontier for data integrityHow to think about documentation as a system of trust📚 Mentioned Resources:MHRA GxP Data Integrity Guidance (2018)FDA Guidance for Industry: Data Integrity and Compliance with CGMPBottle of Lies by Katherine EbanSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
201 episodes
Manage episode 486803281 series 3325357
You’ve heard it before: If it’s not documented, it didn’t happen. But in life sciences, documentation isn’t just a formality—it’s the foundation of trust, compliance, and product quality. In this episode, Subhi Saadeh breaks down what documentation actually means by exploring the principles of ALCOA and ALCOA+.Learn where these principles come from, how they’re applied, and why they still matter—even in today's digital systems. From FDA guidances to $500M data scandals, this episode covers what goes wrong when data integrity isn’t taken seriously.⏱️ Timestamps:00:00 – Introduction: Why Documentation Still Matters01:24 – Defining Data Integrity in Regulated Industries03:06 – ALCOA Explained: Attributable, Legible, Contemporaneous, Original, Accurate07:18 – ALCOA Plus: Complete, Consistent, Enduring, Available08:54 – Real-World Examples: From Whiteout to Warning Letters11:00 – Why Old SOPs Can Ruin New Inspections12:21 – Final Thoughts: Documentation Is About Trust, Not Just Compliance🔍 What You’ll Learn:How ALCOA originated in the 1990s FDA frameworkWhy banning whiteout in labs is about more than inkThe difference between original vs. accurate vs. complete dataHow legacy documentation can break inspectionsThe role of tribal knowledge in document managementThe limits of electronic systems without strong governanceWhy AI and searchability are the next frontier for data integrityHow to think about documentation as a system of trust📚 Mentioned Resources:MHRA GxP Data Integrity Guidance (2018)FDA Guidance for Industry: Data Integrity and Compliance with CGMPBottle of Lies by Katherine EbanSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
201 episodes
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1 197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong 13:50

1 Combi Crumbs: Clinical Trials 101 – From Safety to Strategy 8:21

1 196 - How to Win Your First 90 Days in Pharma and MedTech 9:38

1 195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah 47:41

1 194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer 19:32

1 193 - Bioengineering Grads: Here’s What Recruiters Actually Want to See in 2025 47:17

1 192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes) 4:35

1 191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity 13:09

1 190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong 15:17

1 189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter? 17:14

1 188 – Certified Quality Auditor(CQA) and Audits in the Future 15:39

1 187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained) 16:26

1 186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech 12:38

1 185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder 25:51

1 184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained 30:37

1 183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products 37:11

1 182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma 18:42

1 181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry? 20:14

1 180 - MIT Leadership Expert Reveals Management Secrets for Scientists! 25:18

1 179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing 9:27

1 178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know 31:22

1 177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED 10:58

1 176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski 26:20

1 175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau 39:49

1 174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin 23:57

1 173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's 32:58

1 172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead 34:19

1 171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products? 7:59

1 170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner) 9:43

1 169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective 16:36

1 168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth 13:21

1 167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst 41:13

1 166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success 20:51

1 165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New 1:10:41

1 164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790 13:15

1 163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle 11:19

1 162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them) 17:43

1 161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products 24:09

1 160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED! 19:07

1 159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin 22:24

1 158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show 21:23

1 157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura 21:30

1 156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar 33:01

1 155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach 25:25

1 154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell 37:31

1 153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio 21:56

1 152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh 40:48

1 151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio 33:38

1 150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar 38:58

1 149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens 33:11

1 148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner 26:20

1 147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup 23:15

1 146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens 35:58

1 145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi 40:28

1 144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo 35:36

1 143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young 29:22

1 142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin 30:26

1 141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024) 23:09

1 140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa 30:50

1 139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh 27:43

1 138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager 47:34

1 137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens 18:11

1 136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura 39:53

1 135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson 41:16

1 134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch 41:49

1 133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell 22:26

1 132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner 31:11

1 131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer 42:53

1 130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder 32:25

1 129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens 32:59

1 128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture 52:32

1 127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal 48:25

1 126 - Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd 35:54

1 125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh 42:04

1 124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson 31:01
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