Preparing for FDA GLP Inspection and Management: Best Practices

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Deadline: June 04, 2014 | Date: June 04, 2014

Venue/Country: 38868 Salmon Ter, Fremont, U.S.A

Updated: 2014-04-17 18:48:55 (GMT+9)

Call For Papers - CFP

Description:

This webinar is intended to help you get familiar with FDA Good Laboratory Practice (GLP) Inspection and Preparation ? Dos and Don'ts. This webinar discusses emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for and get ready for a successful FDA inspection: in particular, a list of Dos and Don'ts before, during and after the FDA GLP inspection will be discussed.

This webinar will provide practical, actionable and sustainable guidancefor you to dramatically improve your current practices with awareness and beyond, significantly contributing to hosting successful FDA inspections.

This 60-min webinar will offer great opportunities for you to apply and execute your FDA GLP inspection preparation and readiness in a way to significantly improve your current processes while preparing for a successfulFDA GLP inspection in an efficient and effective way.

Objectives of the Presentation:

Applicable Laws and Regulations

Definitions

FDA Manuals

FDA GLP Inspection Scope

Inspection Classification, Types and Categories

FDA Inspection Process and Assessment of Compliance

Dos and Don'ts Before, During and After an FDA GLP Inspection

Close Out Meeting

Responding to 483s, If Issued

Common Deficiencies

How to Answer Questions

Employee Training

Actual Case Studies

Best Practices

Speaker's PASS-IT Recommendations/Suggestions

Conclusion

Who can Benefit:

CEOs

VPs

Compliance Officers

Attorneys

Regulatory Affairs

Clinical Affairs

Quality Assurance

R & D

Consultants

Contractors/Subcontractors

Anyone Interested in the FDA inspection Process

http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500302?expDate=Ourglocal