Training & seminars
Advanced Process Validation and Cleaning Validation (9 – 11 April 2018) – 3 day Course
9 April 2018 – 11 April 2018
Aim: To develop advanced understanding of Sterile and Non Sterile Process and Cleaning Validation in order tocomply with contemporary regulatory expectations. Putting into perspective the interpretation of regulatory and industry guidance.
Day 1 AM ► Understanding ASEAN PV Guidance and SUPAC
AM ► PIC/S Annex 15 and FDA Guidance on Process Validation
PM ► Ongoing re-validation
Day 2 AM ► Process Performance Qualification
AM ► Process capability analysis for process validation
PM ► Developing a process validation rationale
Day 3 AM ► The process equipment train and cleanability
AM ► PDE a scientific approach to cleaning validation
PM ► Introduction to CIP principles and validation