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POST ID: 5223

Webinar On - FDA Inspection: Preparation and Management

Region: Alaska
Location: 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Ca


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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