This seminar 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 seminar 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.
- 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
- Source Documents/Evidence
- Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
- Key Elements of the Investigation Report
- Deviation Investigators
- Reviewers and Approvers of Deviation Investigations
- Quality Assurance Departments
- Regulatory Affairs Departments
- Quality Control Departments
- Compliance Auditors