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

US FDA’s Draft 2008 Process Validation Guidelines provide and excellent framework for understanding Process Validation. They describe the pri...

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

This highly interactive pre-recorded online course reviews the Production System and its importance within the USFDA Systems Inspection Approach. T...

This highly interactive pre-recorded online course reviews the Production System and its importance within the USFDA Systems Inspection Approach. R...

This highly-interactive, pre-recorded online course reviews the laboratory control system and its importance within the USFDA Systems Inspection Ap...

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...

ICH Q11 has been an industry hot topic for years, and now the guideline has reached the consultation phase. In this recording, captured at ISPE's 2...

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...

How do you apply the new risk-based approach to IT infrastructure? Whether you are new to this or quite experienced you get useful and immediately ...

Ever wonder whether your spreadsheet or other desktop application requires validation? This webinar helps you find out by providing deeper understa...

The pharmaceutical industry is responding to the challenge of significantly improving the way drug development and manufacturing is managed. New co...

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 high ...