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Training & Seminars

Module 2 – Validation Principles and Practices (5 - 7 February 2018) – 3 day Course

Dari Isnin, 05 Februari 2018 -  8:00
Ke Rabu, 07 Februari 2018 -  5:00

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