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181 - Episode 1 - Introduction to Medical Devices and Their Regulatory Landscape (S25E1)
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182 - Episode 2 - The Medical Device Development Lifecycle: From Concept to Commercialization (S25E2)
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183 - Episode 3 - Device Classification and Premarket Pathways - Navigating FDA Clearance (S25E3)
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184 - Episode 4 - Quality System Regulation (QSR): The Backbone of Medical Device Manufacturing (21 CFR Part 820) (S25E4)
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185 - Episode 5 - Good Documentation Practices (GDP) in Medical Devices - The ALCOA+ Standard (S25E5)
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Aspirin (S24E1)
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Acetaminophen (S24E2)
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Ibuprofen (S24E3)
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Naproxen (S24E4)
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Diclofenac (S24E5)
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Celecoxib (Celebrex) (S24E6)
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Penicillin (S24E7)
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Amoxicillin (S24E8)
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Erythromycin (S24E9)
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Azithromycin (S24E10)
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11 Ciprofloxacin (S24E11)
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12 Levofloxacin (S24E12)
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13 Clindamycin (S24E13)
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14 Metformin (S24E14)
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15 Insulin (S24E15)
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16 Glipizide (S24E16)
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17 Sitagliptin (S24E17)
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18 Pioglitazone (S24E18)
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19 Exenatide (S24E19)
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20 Liraglutide (S24E20)
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21 Atorvastatin (S24E21)
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60 – cGCP Fundamentals and Regulatory Overview (S23E1)
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61 - Operational Excellence in Clinical Trials Monitoring & Data Management (S23E2)
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62 - Documentation, Informed Consent, and Safety Reporting (S23E3)
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63 - Audit Readiness and Continuous Improvement in Clinical Quality Systems (S23E4)
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55 - What are cGCPs? Foundations and Ethical Principles (S22E1)
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56 - The Historical Evolution of cGCPs (S22E2)
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57 - Protocol Design, Investigator Responsibilities, and Documentation (S22E3)
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58 - Risk Management and Quality Assurance in Clinical Trials (S22E4)
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59- Data Integrity, Informed Consent, and Recordkeeping in cGCP (S22E5)
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50 – Overview of the cGCP Regulatory Landscape (S21E1)
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51 – In-Depth Analysis of FDA cGCP Regulations (S21E2)
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52 - European and International Regulatory Perspectives (S21E3)
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53 – ICH Guidelines and Global Harmonization (S21E4)
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54- Compliance, Enforcement, and Audit Mechanisms (S21E5)
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46 – cGMP Fundamentals and Regulatory Overview (S20E1)
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47 - Operational Excellence Validation, Equipment & Processes (S20E2)
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48 - Documentation, Lab Practices & Quality Systems (S20E3)
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49 – Audit Readiness and Advanced Topics (S20E4)
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39 - Stability Programs and Shelf Life Determination (S19E1)
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40 - Handling Deviations and Non-Conformances (S19E2)
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41 - Complaint Handling and Product Recalls Protecting Patients (S19E3)
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42 - Case Study 1 Illustrative GMP Failure (S19E4)
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43 - Case Study 2 Example of Successful GMP Implementation (S19E5)
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44 - Preparing for Regulatory Inspections (S19E6)
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45 - Current Trends and Future Directions in GMP (S19E7)
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64 - FDA 2025 Inspection Operations Manual - What to Expect When You’re Expecting… an FDA Inspection (S19E8)
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33 – The Role of GMP Audits in Ensuring Compliance (S18E1)
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34 - Planning and Preparing for a GMP Audit (S18E2)
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35 – Conducting the GMP Audit Best Practices (S18E3)
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36 – Audit Findings and Corrective and Preventive Actions (CAPA) (S18E4)
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37 – Establishing and Maintaining a GMP Quality Management System (QMS) (S18E5)
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38 – FDA Form 483 Implications and Impact (S18E6)
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27 - Introduction to Good Laboratory Practices (GLP) (S17E1)
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28 – Key Elements of GLP Organization and Personnel (S17E2)
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29 – GLP Requirements for Facilities and Equipment (S17E3)
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30 - Test Systems and Test and Reference Items in GLP (S17E4)
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31 - GLP Protocols and Standard Operating Procedures (S17E5)
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32 - Data Management, Records, and Reporting in GLP (S17E6)
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21 - Principles of Good Documentation Practices (GDP) (S16E1)
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22 – The ALCOA+ Principles Ensuring Data Integrity (S16E2)
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23 - Standard Operating Procedures (SOPs) Your GMP Blueprints (S16E3)
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24 - Batch Records The History of a Batch (S16E4)
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25 - Laboratory Notebooks and Data Recording (S16E5)
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26 – Electronic Records and Signatures Navigating 21 CFR Part 11 (S16E6)
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15 - Process Validation: Ensuring Consistent Quality (S15E1)
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16 - Cleaning Validation: Preventing Cross-Contamination (S15E2)
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17 - Equipment Qualification: IQ, OQ, PQ (S15E3)
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18 - Change Control: Managing Modifications Effectively (S15E4)
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19 - Materials Management: From Raw Materials to Finished Products (S15E5)
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20 - Quality Risk Management: A Proactive Approach (S15E6)
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4 - Understanding FDA 21 CFR Part 210 (S14E1)
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5 - FDA 21 CFR Part 211 Organization and Personnel (S14E2)
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6 – FDA 21 CFR Part 211 Buildings and Facilities (S14E3)
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7 – FDA 21 CFR Part 211 Equipment (S14E4)
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8 – FDA 21 CFR Part 211 Control of Components and Drug Containers (S14E5)
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9 – FDA 21 CFR Part 211 Production and Process Controls (S14E6)
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10 – FDA 21 CFR Part 211 Packaging and Labeling Control (S14E7)
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11 – FDA 21 CFR Part 211 Holding and Distribution (S14E8)
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12 – FDA 21 CFR Part 211 Laboratory Controls (S14E9)
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13 – FDA 21 CFR Part 211 Records and Reports (S14E10)
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14 – FDA 21 CFR Part 211 Returned and Salvaged Drug Products (S14E11)
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1 - What are cGMPs? (S13E1)
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2 - The Historical Evolution of GMP (S13E2)
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3 - Global Regulatory Frameworks and cGMP (S13E3)
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166 - Future of Drug Discovery (S12E1)
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167 - Precision Medicine & Genomic Innovations (S12E2)
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168 - Advances in Biotechnology & Gene Therapy (S12E3)
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169 - Regulatory Science of the Future (S12E4)
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170 - Emerging Trends in Personalized Development (S12E5)
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171 - Patient Data & Digital Health Records (S12E6)
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172 - Sustainability & Green Chemistry in Pharma (S12E7)
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173 - The Evolving Role of Al in R&D (S12E8)
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174 - Global Collaboration & Open Innovation (S12E9)
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175 - Balancing Innovation and Safety (S12E10)
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