Best Practices in Responding to Form 483s
Friday, February 8, 2013 from 10:00 AM to 11:00 AM (PST)
Palo Alto, CA
This webinar on Form 483 responses will cover strategies for FDA facility inspections and responses to inspectional findings. It will discuss tips on responding appropriately to avoid escalating most inspectional findings into a warning letter, including preparing for the top-ten 483 findings.
Why Should You Attend:
Despite your preparations, an FDA investigator arrives unannounced and hands you a Form 483. You have limited time to correct all the problems and even less time to create a response that will satisfy the FDA regional office.
The next few steps you take will make the difference between receiving a warning letter, which is published and Google indexed, and possibly becoming listed as a high risk facility under new provisions of the Food Safety Modernization Act.
In this webinar Marc Sanchez, who practices solely on FDA matters, will teach you how to respond efficiently to a Form 483. He will explain what actions to take from your first response through completion and follow-up.
During this webinar, you will learn:
- How to respond on site to an accurate observation.
- What to say when you think the investigator is wrong.
- How to develop a viable remediation plan quickly.
- 7 things NOT to say in your Form 483 response - unless you want a Warning Letter.
- 4 statements the FDA loves to hear - and how to back them up with facts.
Areas Covered in the Webinar:
- Form 483 Responses
- Top Ten Findings in Food, Dietary Supplements and Medical Device.
- Warning Letters
- Correcting 483 Observations
When & Where
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