GMP 101: The Quality and Compliance Podcast

Dr Saqib Choudhary
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Welcome to GMP 101, the essential audio guide for professionals in the pharmaceutical and biotech industries. Navigating regulations is complex. We break down the workflows that keep you inspection-ready. We cover: - Compliance: GMP, GDP & Inspection Readiness - Validation: CQV, CSV, Cleaning and Process Validation - Quality Systems: Risk Management, Audits, Vendor Qualification, Inspection Readiness Dr Saqib Choudhary’s brief profile: - +26 years of experience (18 yrs in the UK) - Successful hosting of over 48 inspections (US FDA, EMA, MHRA, HPRA, WHO, ANVISA, and more) - Over 500 audits

Episodes

  1. SEASON 1, EPISODE 1 TRAILER

    Introduction to GMP101 (Trailer)

    (this is the correct audio version) SECTION 1 — PIC/S FOUNDATION • What is PIC/S? • Why PIC/S matters globally • Structure of PIC/S guidance • Relationship between PIC/S, EU GMP, WHO, ICH • How PIC/S inspections actually work SECTION 2 — QUALITY MANAGEMENT SYSTEM • QMS Fundamentals • Management oversight & leadership • Pharmaceutical Quality System (ICH Q10 alignment) • CAPA & Deviations • Root Cause Analysis & investigation science • Change Control & risk impact assessments • Product Quality Review (PQR / APR) SECTION 3 — PREMISES & EQUIPMENT • Facility design principles (flows, zoning, segregation) • Cleanroom classifications & EM • HVAC & differential pressures • Equipment qualification (IQ/OQ/PQ) • Calibration, maintenance & instrument control SECTION 4 — PRODUCTION & OPERATIONS • Documentation controls (GDP & Data Integrity) • Batch manufacturing records • Contamination control • Line clearance • Material management & traceability • Packaging and labeling • In-process controls SECTION 5 — QUALITY CONTROL • QC sampling and method validation • Stability programs • Out of Specification (OOS) • Out of Trend (OOT) • Lab data integrity SECTION 6 — VALIDATION & QUALIFICATION • Process Validation lifecycle • Cleaning validation • CSV & Annex 11 • Spreadsheets & hybrid systems SECTION 7 — ANNEX 1 STERILE MANUFACTURING • Aseptic processing • CCS — contamination control strategy • Environmental monitoring • Media fills • Personnel qualification • Gowning SECTION 8 — DATA INTEGRITY • ALCOA+ • Data lifecycle • DI risk assessments • Human error reduction SECTION 9 — INSPECTION READINESS • How inspectors think • Common PIC/S findings • Interview techniques during inspection • How to prepare staff • Inspection room logistics • Evidence presentation • Mock inspection program

    4 min

  2. SEASON 1, EPISODE 1 TRAILER

    Introduction to GMP101

    SECTION 1 — PIC/S FOUNDATION What is PIC/S?Why PIC/S matters globallyStructure of PIC/S guidanceRelationship between PIC/S, EU GMP, WHO, ICHHow PIC/S inspections actually work SECTION 2 — QUALITY MANAGEMENT SYSTEM QMS FundamentalsManagement oversight & leadershipPharmaceutical Quality System (ICH Q10 alignment)CAPA & DeviationsRoot Cause Analysis & investigation scienceChange Control & risk impact assessmentsProduct Quality Review (PQR / APR) SECTION 3 — PREMISES & EQUIPMENT Facility design principles (flows, zoning, segregation)Cleanroom classifications & EMHVAC & differential pressuresEquipment qualification (IQ/OQ/PQ)Calibration, maintenance & instrument control SECTION 4 — PRODUCTION & OPERATIONS Documentation controls (GDP & Data Integrity)Batch manufacturing recordsContamination controlLine clearanceMaterial management & traceabilityPackaging and labelingIn-process controls SECTION 5 — QUALITY CONTROL QC sampling and method validationStability programsOut of Specification (OOS)Out of Trend (OOT)Lab data integrity SECTION 6 — VALIDATION & QUALIFICATION Process Validation lifecycleCleaning validationCSV & Annex 11Spreadsheets & hybrid systems SECTION 7 — ANNEX 1 STERILE MANUFACTURING Aseptic processingCCS — contamination control strategyEnvironmental monitoringMedia fillsPersonnel qualificationGowning SECTION 8 — DATA INTEGRITY ALCOA+Data lifecycleDI risk assessmentsHuman error reduction SECTION 9 — INSPECTION READINESS How inspectors thinkCommon PIC/S findingsInterview techniques during inspectionHow to prepare staffInspection room logisticsEvidence presentationMock inspection program

    4 min

Trailers

About

Welcome to GMP 101, the essential audio guide for professionals in the pharmaceutical and biotech industries. Navigating regulations is complex. We break down the workflows that keep you inspection-ready. We cover: - Compliance: GMP, GDP & Inspection Readiness - Validation: CQV, CSV, Cleaning and Process Validation - Quality Systems: Risk Management, Audits, Vendor Qualification, Inspection Readiness Dr Saqib Choudhary’s brief profile: - +26 years of experience (18 yrs in the UK) - Successful hosting of over 48 inspections (US FDA, EMA, MHRA, HPRA, WHO, ANVISA, and more) - Over 500 audits

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