Equipment Commissioning & Qualification, Process Validation (Stages 1, 2, and 3), Cleaning Validation, Steam Sterilisation Validation, Process Simulations, Change Control and Deviation Management, Validation Protocols and Reports. Analytical Method Validation, Computer System Validation and GAMP, Utility System (WFI, Clean Steam etc.) Qualification including facilities & HVAC, Medical Device Qualification, Pharmaceutical Validation – Solid dosage, Inhalation aerosols. Background to and practical implementation of Quality Risk Management (QRM) principles with a focus on the tools utilised.