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Recording: Why an Effective CAPA System is Important for Excipient Companies

Wednesday, November 15, 2023 - 11:00am to 1:00pm EST

Jim Morris – Principal Consultant, IQS Consulting
> Dr. Irwin B. Silverstein - Lead Trainer and Consultant, IPEC-Americas Excipient Learning Lab.

The presentation focused on:
Examples of recent FDA excipient inspection findings and actions, describe FDA’s definition of excipients as “drug components” and review drug product/component adulteration provisions of the Food, Drug & Cosmetic Act. In addition, regulatory requirements for handling non-conformances, FDA’s expectations for investigations, and best-practice strategies (with examples and poll questions) for addressing corrective and preventative actions (CAPA) will be covered.

Learning/Awareness Objectives
Attendees will be able to:
> Identify recent FDA concerns and actions related to excipient manufacture
> Understand CAPA and CAPA p rograms
> Understand the requirements around non conformance handling
> Recognize the main elements of an investigations program
> Understand FDA’s expectations related to investigations
> Recognize best practices and common issues with investigations handling

Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs professionals
> Quality Assurance/Quality Control
> Manufacturing personnel
> Technical service and development

Note: Did you know this webinar may count toward continuing education credits? Check with your credentialing organization to confirm. A certificate of participation will be available for download upon completion of the webinar.