Training & seminars
Module 2 – Validation Principles and Practices (5 - 7 February 2018) – 3 day Course
5 February 2018 – 7 February 2018
Aim: This subject aims to introduce students to the validation principles covered in PIC/S, ICH, EU & FDA cGMPs and to extendthe principles to practical outcomes.
Day 1 AM ►Validation Principles & International Regulations PM ►Validation Master Plans and Validation Documents PM ►Equipment Qualification and Commissioning
Day 2 AM ►Introduction to Process Validation and Cleaning Validation PM ►Compiling URS against FDS documents
PM ►Preparing DQ, IQ, OQ and PQ protocols
Day 3 AM ►Protocol Execution
AM ►Deviation Management
PM ►Final Summary Report