Utilities Design & Validation (Overview) USP PW, WFI & Compressed Air Acceptance Criteria March 7 MID-TERM EXAMINATION (Lectures 1-7) Lecture 8 SISPQ Process Validation & new Guidance Document Process Validation FDA’s ICH Q8A Overview Lecture & Week Anticipated Topic(s) Given (approx) Lecture 9 Air Waste & CFCs CAA, Montreal Protocol – Environment Water & Water Waste CWA, SWDA, NPDES – Solids & Solid Waste RCRA, DOT, RMW – Emergencies & CRTK CERCLA, SARA, EPCRA – Lecture 10 BMS, MRP/ERP, CDS, LIMS CSV CSV and 21 CFR 11 Spreadsheets Related SOPs Lecture 11 Cleaning Validation & MACO Environmental Mapping Studies & MKT Cleaning, Mapping, & Continuous Sampling: AQLs & ANSI Z1.4 Packaging Lecture 12 Analytical Testing of “Figures Merit” AMV & Micro System Suitability Analytical & Bio-analytical Method Validation Microbiology & Sterility Testing Stability Testing Lecture 13 for the “GMPs 21st Century” QbD, QbR, and Quality Risk Management Inspections & QBD The & PAIs “QS Approach” Other Inspections and Audits Lecture 14 PAT REMS PAT & Other PDMA Initiatives Other Topics (as time allows) May 6 FINAL EXAMINATION (Lectures 8-14) Supplemental Lectures there are additional presentations that cover specific topics; – we shall address these as class time and interest allow. Any/all supplements are fair game for exams and homework. Part 3: Academic Calendar (copied from the Highlander Pipeline) January 18 Monday Martin Luther King, Jr. Day January 19 Tuesday First Day of Classes
Utilities Design & Validation (Overview) USP PW, WFI & Compressed Air Acceptance Criteria March 7 MID-TERM EXAMINATION (Lectures 1-7) Lecture 8 Process Validation SISPQ Process Validation & FDA’s new Guidance Document ICH Q8A Overview Lecture & Week Given (approx) Anticipated Topic(s) Lecture 9 Environment Air Waste & CFCs – CAA, Montreal Protocol Water & Water Waste – CWA, SWDA, NPDES Solids & Solid Waste – RCRA, DOT, RMW Emergencies & CRTK – CERCLA, SARA, EPCRA Lecture 10 CSV BMS, MRP/ERP, CDS, LIMS CSV and 21 CFR 11 Spreadsheets Related SOPs Lecture 11 Cleaning, Mapping, & Packaging Cleaning Validation & MACO Environmental Mapping Studies & MKT Continuous Sampling: AQLs & ANSI Z1.4 Lecture 12 AMV & Micro Analytical Testing “Figures of Merit” System Suitability Analytical & Bio-analytical Method Validation Microbiology & Sterility Testing Stability Testing Lecture 13 Inspections & QBD “GMPs for the 21st Century” QbD, QbR, and Quality Risk Management The “QS Approach” & PAIs Other Inspections and Audits Lecture 14 PAT & Other Initiatives PAT REMS PDMA Other Topics (as time allows) May 6 FINAL EXAMINATION (Lectures 8-14) Supplemental Lectures – there are additional presentations that cover specific topics; we shall address these as class time and interest allow. Any/all supplements are fair game for exams and homework. Part 3: Academic Calendar (copied from the Highlander Pipeline) January 18 Monday Martin Luther King, Jr. Day January 19 Tuesday First Day of Classes