Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
If you work for any firm that manufactures products regulated by FDA, you very likely will experience an FDA inspection.
You should have a well developed quality system in place, but FDA eyes sometimes expect something slightly different, or they may see actions or practices they believe are contrary to FDA requirements and then issue an FD-483
Virtually every regulated company will receive an FDA-483 at some point in time and need to create a written response to FDA, although FDA has no legal authority to demand a written response
Repeat Observations from a previous FD 483 are a red flag to FDA
Failure to adequately respond to the FDA-483 will begin the FDA regulatory process.
An FDA Warning Letter is your last chance to avoid an FDA regulatory confrontation. You must provide a detailed complete Warning Letter response and have a meeting with FDA.
Why should you Attend: Effective and FDA accepted response are critical to regulatory success of FDA regulated business
My experience with FDA and Industry have shown me that some firms make a very limited response to FDA, and when FDA reviews the response they feel to company did not fully comprehend, the problems.
This webinar will prepare you fully evaluate the FDA observation, and prepare a detailed response to FDA and convince FDA no further action is needed by them
Areas Covered in the Session:
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