Two Day Seminar on How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach - Brisbane, United States - December 1-2, 2016 - Research and Markets

DUBLIN--()--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?

Areas Covered:

- 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

Learning Objectives:

- 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

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716