DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach" conference to their offering.
If you are looking for the answer to these questions, you will certainly benefit from attending this seminar on preparing for FDA inspections:
- Do you worry about an upcoming FDA inspection?
- Do you know how you should behave during the inspection?
- Do you know what an end to end FDA inspection process looks like?
- Do you know what an FDA investigator(s) will look for?
- Do you know how to proactively assess and mitigate FDA compliance risks?
- Do you know what information you should get ready ahead of an FDA inspection?
- Does your organization have a game plan for managing an FDA inspection?
- Does your organization know how to respond to and manage FDA observations (483s), or warning letters?
- To provide an overview of the FDA inspection program and key success factors for a manufacturer.
- To introduce the best practices on how to manage inspections including a template of game plan.
- To introduce the industry best practices on what information should be prepared ahead of inspection including a checklist.
- To introduce the best practices including templates on how to respond to and closeout FDA 483s and warning letters.
- To introduce the best practices and toolkit on how to assess readiness for a FDA inspection, and how to proactively identify and mitigate compliance risks.
Additionally attendees will be provided with:
- Toolkit on how to assess a quality system's readiness, and identify and mitigate potential compliance risks.
- A checklist of information that should be prepared prior to in
- Background about FDA inspection program.
- How to proactively assess quality system readiness for FDA inspection.
- How to identify compliance risks.
- How to proactively mitigate before, during and after the inspection.
- How to respond to 483s and warning letters including templates based on industry best practices.
For more information about this conference visit http://www.researchandmarkets.com/research/n262rk/how_to_prepare