This presentation discusses the challenges and benefits of applying a science and risk based commissioning and qualification approach within a cont...

This highly-interactive, online course reviews the quality system and its importance within the USFDA Systems Inspection Approach, as well as the r...

This course provides the background for the origins of the ICH guidelines, Q8(R2), Q9, Q10 and Q11. It covers development and manufacture of drug s...

Understand - utility requirements and system capacity evaluation - how to perform work without interrupting existing operations - HVAC system evalu...

Good operational practices may be the key to good cGMP operations. A poor facility design can weaken even the best operations. In this webinar, lea...

A detailed and comprehensive GAMP interpretation of the new revised EU GMP Annex 11 has been produced by a core GAMP CoP Task Team of industry expe...

A review of the recent changes in the FDA's thinking on lifecycle based process validation as published in their long awaited update to the 1987 PV...

This course provides a look at new information in the Water and Steam Systems (Second Edition)Baseline Guide.

It will touch on the hig...