Compliance 2014 - Webinar On - FDA Inspection: Preparation and Management

Description :
This webinar is intended to help you get familiar with FDA inspection process so that it can be prepared and managed in a proactive and effective manner.
This webinar discusses practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.
This webinar will provide great opportunities to become familiar with the FDA inspection process. The speaker will share his new and useful information for you to consider for implementation and to greatly improve your current process.
Areas Covered in the Session :
Applicable Laws and Regulations
FDA Manuals
Inspection Guides
Hosting an FDA Inspection
Field Management Directives
Inspection Types and Categories
Inspection Classification
FDA Forms 482 and 483
Establishment Inspection Reports (EIRs)
What/How to Prepare for and Manage an FDA Inspection
How to Communicate Before, During and After inspection: Dos and Don’ts
Inspection Preparation Procedures
Close Out Meeting
Responding to 483s, If Issued
How to Communicate with Emotional Intelligence
Employee Training
Actual Case Studies
Conclusion
Who Will 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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