Contemporary Concepts in Pharmaceutical Validation (PME640)

Current and evolving validation concepts and standards in pharmaceutical manufacturing, including FDA’s GMPs for 21st Century, Risk Assessments (Risk-MaPP, ICH Q7a-Q10, FMEA) and statistics in validation, Commissioning and Qualification (ISPE and ASTM), Computer Systems Validation, Cleaning Validation, Spreadsheet Validation, Lean Manufacturing and Six Sigma, PAT initiative, Equipment Qualification vs. CSV (GAMP and AAPS guidelines). Preparation of draft validation documentation, including master plans, protocols, test procedures and reports. Focus is on concepts and principles required to implement these new qualification and validation approaches in a pharmaceutical manufacturing environment in compliance with FDA and international regulations. Needs knowledge of basic statistics concepts.  Prerequisites: PME 530, PME 540.