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PRACTICAL GMP RECORDS MANAGEMENT - A Risk Based Approach
(Course / Training / Workshop)
"Say what you do and do what you say" - and DOCUMENT IT!
This seminar will focus on changes to GMP stimulated by the introduction of ICH Q10 on Pharmaceutical Quality Systems (PQS) with main focus on changes to Chapter 4 on Documentation of EU GMP.
■ What is the impact of ICH Q10 and proposed Changes to EU GMP Chapter 4 on Documentation for the GMP Environment?
■ The framework for a Pharmaceutical Quality System
■ Understanding the Difference between Instructions and Records propsed by these Changes to EU GMP
■ How good are your SOPs (Instructions) and the Evidence of Actions (Records)?
Event Website : PRACTICAL GMP RECORDS MANAGEMENT - A Risk Based Approach
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