Description
This seminar is intended to discuss lessons learned from recent FDA enforcement actions in different areas including changes in FDA enforcement and inspection policy in 2017.This presentation is further intended to help you better prepare for and manage an FDA inspection in a proactive and effective manner.
The speaker will discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including important Dos and Don’ts. This presentation will provide great opportunities to become aware of critical lessons learned from FDA enforcement actions and changes in FDA enforcement policy.
Why should you attend:
This seminar will provide great opportunities to better understand FDA inspection policy including areas of focus so that industry can adequately prepare for and manage FDA inspection matters in an effective, sustainable manner.
Back ground of the topic:
FDA-regulated industry is subject to FDA enforcement inspection. There has been recent policy change in FDA inspection affecting all healthcare industry. It is imperative all industry should be well aware of new policy for FDA enforcement to get better ready for an FDA inspection.
Areas Covered in the Session:
- Applicable Laws and Regulations
- FDA Inspection Policy
- Recent Changes in FDA Enforcement
- Areas of Focus on FDA Enforcement
- Lessons Learned from 2016 Enforcement Actions
- Key Considerations for FDA Inspection
- FDA Inspection: 483, Warning Letter, and Permanent Injunction
- Communication: Dos and Don’ts
- Training Requirements
- FDA Enforcement in 2017
- Case Studies
- Speaker’s PASS-IT Suggestions/Recommendations
Who will benefit:
- Healthcare industry (pharmaceuticals),
- biotechnology,
- and medical device/IDs,
- healthcare professionals
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