Training & seminars

Module 2 – Validation Principles and Practices

28 March 2016

Where

The Boulevard St Giles Premier Hotel<br />Mid Valley City<br />Lingkaran Syed Putra,<br />59200 Kuala Lumpur, Malaysia

Aim: This subject aims to introduce students to the validation principles covered in PIC/S, ICH, EU & FDA cGMPs and to extend the principles to practical outcomes.

Day 1

AM ►Validation Principles & International Regulations

PM ►Validation Master Plans and Validation Documents

PM ►Equipment Qualification and Commissioning

Day2

AM ►Process 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

 

Download the brochure and registration form.

 

 

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