Current Trends in FDA Inspections

This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.

Why Should You Attend:

For a quality and compliance system to be successful, it is essential to understand the current trends in FDA inspections to ensure that your organization’s execution and monitoring of the critical quality systems will meet regulatory challenges. This is done through a number of activities, which can include monitoring changes in FDA programs, guidelines, and regulatory initiatives. An example of an important change is the recent Food and Drug Agency Safety and Innovation Act (FDASIA), which granted the FDA with new enforcement tools.

Also, it is important to monitor the latest regulatory actions taken by the Agency to understand what is important to monitor in your quality systems. This can be done through the monitoring of warning letter, FDA 483s, and other regulatory actions to establish benchmarks to measure your inspection readiness.

This webinar will focus on inspectional trends, applicable guidelines, and regulatory actions and examples of systems that can be implemented to ensure continuous compliance.

Areas Covered in the Webinar:

• FDA Inspectional Programs
• FDA Use of Quality Systems in Inspections
• FDA Inspectional Priorities
• Foreign Inspections
• FDA Enforcement Tools
• FDASIA Regulatory Impact
• Annual Trends in FDA 483 Observations
• Warning Letter Examples.
• How to Prepare for An FDA Inspection

Who Will Benefit:

• Pharmaceutical Professionals
• Top and Middle Management
• Compliance Management
• Regulatory Affairs Personnel
• API and Excipient Providers
• Manufacturing Professionals
• Service Providers
• Laboratory Professionals
• Research and Development Personnel
• Quality Professionals