Description

In FDA-regulated industry, it is imperative that firms should be well aware of recent policy changes and understand what laws and regulations apply for FDA-regulated products on the US market (e.g., food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics).

This conference is intended to discuss FDA policy changes including changes for FDA inspection in 2019 under new political atmosphere/environment.  This presentation is further intended to help industry better prepare for and manage an FDA inspection in a proactive and effective manner.  The speaker will share his actionable tips and advice in view of FDA policy changes in 2019.

The speaker will also discuss 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 presentation will provide great opportunities to become familiar with what lessons we learn from FDA enforcement and inspection practices.

The speaker will share his PASS-IT recommendation/suggestions – dos and don’ts. 

Areas To Be Covered:

• Laws and Regulations
• 2019 FDA Policy Changes
• FDA Inspection Manuals
• FDA Inspection Types and Depth of Inspection
• How to Avoid Common Deficiencies
• Actionable Inspection Preparation and Management
• Communication with EQ Skills
• Employee Training
• Actual Case Studies
• Speaker’s PASS-IT Suggestions/Recommendations-Dos and Don’ts
• 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 Drug Review and Approval Processes