Comparability Protocols (CPs): How and when to use them for POST APPROVAL CHANGES (FDA)
Venue: Online Event
|Event Date/Time: Oct 29, 2010||End Date/Time: Oct 29, 2010|
Areas Covered in the Seminar:
- Important factors to know in order to use Comparability Protocols:
- What are Comparability Protocols?
- What are the benefits of using Comparability Protocols?
- When might a Comparability Protocol be useful for a CMC Change?
- What about pre-approval changes?
- When might a Comparability Protocol be inappropriate to use?
- How should a Comparability Protocol be submitted?
- What happens after submission?
- What are the basic elements of a Comparability Protocol?
- How much Risk Potential can be reduced by using a Comparability Protocol?
- New and expanded uses for Comparability Protocols.
Who Will Benefit:
The webinar will provide you with the basics for utilizing the Comparability Protocol and assist in helping shorten the time for implementing pre and post approval changes. It will also provide you with the latest uses or new products and your new of existing facility changes. Those that will benefit the most are:
- Quality Assurance Managers and staff
- Regulatory Affairs Management and staff
- Project Managers
- Validation Personnel
- Change Control Coordinators
- Anyone initiating a change to a product