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(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

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