Purpose
Attendees will learn what the new Guidelines entail, how they are different from other guidelines and how the new guidelines offer much more flexibility than other current guidelines. They will also learn what markets they can be used in and how to implement them.
Who Should Attend
Validation Personnel, Q.A., Regulatory, Manufacturing, Engineering, Development and any one that is involved in supporting Process Validation.
Course Description
- A review of current Process Validation Guidelines (U.S., ICH, former E.U.) and a comparison to the new proposed E.U. Guidelines
- Discussion of provisions in the New Guidelines approaches that allow for more flexibility and greater ease and efficiency in performing process validations
- Several approaches to the Validation Master Plans
- Validation Protocol Templates
- Interacting with Clients to resolve differences between your and their approaches to Process Validation
- Case studies
- Wrap Up
