2014 - Preparing for FDA GLP Inspection and Management: Best Practices

Instructor: David Lim
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
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