Comparability Protocols (CPs): How and when to use them for POST APPROVAL CHANGES - Webinar By ComplianceOnline

Submitted by Anonymous on Fri, 10/22/2010 - 02:28

Start: 10/29/2010 10:00 am

End: 10/29/2010 11:00 am

Timezone: US/Pacific

This Comparability Protocols training will provide you with the basics for use as well as provide you with new and expanded ways of using CPs. It will also assist you in finding ways to help shorten the time for implementing pre and post approval changes.
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.