Preparing for an FDA Preapproval Inspection
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An FDA preapproval inspection can be an intimidating prospect for pharmaceutical or medical device manufacturers.
They’re no fun to undergo, but possible to pass with the proper preparation.
Everything rides on your preapproval inspection.
But investigators keep taking new angles on everything from material flow and CAPA to stability data. Plus, the FDA is bringing along CDER inspectors — and others — who ask very different questions than the field inspectors.
Don’t let Form 483 observations slap you with last-minute costs, delays and negative publicity.
How can you be sure your sites are thoroughly prepared for these inspections?
Join Frederick Branding and Cathy Burgess for this 90-minute webinar and discover how to prepare for and manage these inspections to avoid misunderstandings, prevent delays in the approval process and eliminate unnecessary costs.
Sign up your entire team to discover:
- Why you need to ensure a successful inspection
- Guidance on inspection activities — from drug development to QA controls to document reviews
- The benefits of a risk-based approach to inspections and what it entails
- How to prepare for an inspection and what documents are needed
- How to best handle document requests to avoid problems
- The best ways to manage an FDA inspection, including key Do’s and Don'ts
Preparing for an FDA Preapproval Inspection is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your office at home.
Of course, Mr. Branding and Ms. Burgess will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.
Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.
Register now to get the tools you need to turn burdensome inspections into opportunities to fine-tune a well-developed quality assurance system.