Description

All FDA regulated industries are subject to routine FDA enforcement inspections. Recent FDA changes in its inspection and enforcement policies for 2017, however, will require a thorough knowledge and understanding of the new rules and regulations in order to be prepared for these inspections.  Failure to be in compliance with FDA inspections can result in fines, suspension of operations, and more.   OnlineAudio Training has prepared a special conference to discuss these changes, and ways you can manage and prepare for an FDA inspection proactively while following these new guidelines.The conference will center around lessons learned from 2016 FDA enforcement actions, and will give you the practical knowledge you need to manage future FDA inspections efficiently.  The seminar will give a thorough, targeted understanding of the FDA inspection policy including the Do’s and Don’ts of preparation,and specific areas of focus needed in order to remain compliant with new 2017 regulations.

Areas Covered in the Session:

This seminar will cover many pertinent aspects of remaining compliant to the FDA inspections, including:

• New FDA inspection policies for 2017
• Changes in in FDA enforcement that will affect your industry
• Training requirements
• 2017 FDA enforcement policies
• Applicable Laws and Regulations
• Specific areas of focus for FDA enforcement
• Targeted, key considerations for FDA inspections
• Case studies, including lessons learned from 2016 enforcement actions
• Do’s and Don’ts of an effective FDA inspection
• FDA inspection: 483, warning letter, and permanent injunction
• Speaker’s suggestions and recommendations for passing FDA inspections

Who will benefit:

The information presented in this seminar is invaluable to any industry subject to FDA requirements, inspections, and enforcement policies.  These industries can include:

• Producers of medical devices/IDs
• Healthcare professionals in any field
• Biotechnology
• Pharmaceutical industries