4-Hr Virtual Training: How to Respond to an FDA Investigation

Why Should You Attend:

This webinar will illustrate how to respond to an FDA investigation. It could be a 483 observation, a warning letter, or a consent decree, all of which will impact how you carry on your business while under investigation.

The course will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

Learning Objectives:

• What should a company do if the FDA shows up unannounced
• How should a company respond to 483 observations or a warning letter
• The effect an FDA investigation can have on a company
• The basic concepts that should be employed by everyone regulated by the FDA
• How a company can prepare for situations like this
• Lesson learned
• How a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business

Areas Covered in the Webinar:

• Unannounced FDA visits
• Responding to a 483 or a warning letter
• Effect of an FDA investigation
• Basic concepts that should be employed by everyone regulated by the FDA
• Preparing for FDA audits
• Lessons learned
• Balancing preparing for the FDA investigation or enforcement action and still running a profitable business

Who Will Benefit:

• Quality Assurance Staff
• Quality Control Staff
• Engineers
• IT Staff
• Manufacturing Supervisors and Managers
• Documentation Staff
• Directors, Managers, Supervisors