Comparability Protocols (CPs): How and when to use them for Post Approval Changes

Why Should You Attend:

Over the past few years the FDA has searched for ways to improve the process of getting faster approval of changes through the agency and provides those processing these changes a way of improving the quality of the information that is being submitted by the requestor. More and more regulated industry has been delayed and implementing very important changes due to the filing required and the length of time taken to review the information submitted to the agency. This has frustrated not only the requestor but the FDA reviewers as well. In answer to this problem the FDA has drafted a guidance document on writing and submitting Comparability Protocols.

Learn when to use them and when not to use them. Get the information needed to write the protocol that will reduce the review time of the FDA staff and reduce your time and implementing your changes. Know how to reduce the risk to your product changes and improve the comfort level of the FDA in your changes impacting ISQPP.

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
• Consultants
• Validation Personnel
• Change Control Coordinators
• Anyone initiating a change to a product

Instructor Profile:

James E. Ingram, CPP, FM, is the President of INGRAM Consulting Services and has over 30 years experience in Manufacturing and Packaging of Pharmaceutical, Food and Cosmetic products. Over 16 years of his career has been spent in management of compliance processes 11 of which were with GlaxoSmithKline where he was the Manager of North American Change Control. During this time Jim was the Point Person for insuring that all documents and data were available for audits and inspections. Over the past 7 years Jim has provided consulting services in all areas of compliance processes including custom training programs.

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