This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.
Areas Covered in the Session :
Review of FDA and Regulatory Requirements for Investigations
What is the definition of a Deviation?
Types of Deviations/Identification of Deviations
Conducting the Investigation
Interviews – do’s and don’ts
Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
Key Elements of the Investigation Report
Who Will Benefit:
Reviewers and Approvers of Deviation Investigations
Quality Assurance Departments
Regulatory Affairs Departments
Quality Control Departments