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Training & Seminars

Advanced Process Validation and Cleaning Validation (9 – 11 April 2018) – 3 day Course

Dari Isnin, 09 April 2018 -  8:00
Ke Rabu, 11 April 2018 -  5:00

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