Answering and Replying to an FDA 483
A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or break your organization and its standing with the regulators. Areas CoveredGMP ComplianceRegulatory requirementsHistoryApplicationDo’s and don’tsCourse Level - Basic understanding of GMP compliance principles. Experience with 483 observation response Who Should Attend Those new to the practice and those who would like an updateExperienced as well as inexperiencedWhy Should You AttendIf you are new to the topic or need to brush up on the expectations or how to react to 483s consider attending.
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A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or break your organization and its standing with the regulators.
Areas Covered
- GMP Compliance
- Regulatory requirements
- History
- Application
- Do’s and don’ts
Course Level - Basic understanding of GMP compliance principles. Experience with 483 observation response
Who Should Attend
- Those new to the practice and those who would like an update
- Experienced as well as inexperienced
Why Should You Attend
If you are new to the topic or need to brush up on the expectations or how to react to 483s consider attending.
