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Conference

How to Prepare for, Manage, and Follow-up to an FDA Inspection - Webinar By GlobalCompliancePanel

About this event

Web site
bit.ly/sDRsZ2…
When
21 Dec 2011
Where
Online Training, Wilmington | DE | Zip 19801, United States
Organiser
GlobalCompliancePanel
Contact address
webinars web
online training
Suite 1200
Wilmington
Delaware
United States
Tel
18004479407
Fax
3022886884
E-mail
webinars@globalcompliance…

The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance is not good, it is not the show that may close, it is YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Areas Covered in the Session:
How to prepare for an FDA inspection
Development and contents of an SOP for FDA inspection
Personnel training before inspection
How to behave during an inspection
What to show FDA during an inspection
Proper Post-inspection Follow-up
Limitations of scope of inspection
Response to investigation findings
FDA guidance documents used by their inspectors
Who Will Benefit:
Internal / External Auditors
Regulatory Management
Quality Assurance Professionals
Consultants
Sales/Marketing Management
Senior and mid-level Management
Quality System Auditors

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884