This seminar will help attendees with the fundamentals and best practices for investigating deviations. It will focus on using facts and objective evidence to arrive at root cause and CAPA. To accomplish successful deviation investigations this course will focus on how to avoid the drawbacks that may occur during FDA inspections. We will also discuss some tips and tricks to reduce and eliminate 483 observations. Ensure compliance by learning how to identify and avoid potential pitfalls during deviation investigations.
- Review of FDA and Regulatory Requirements for Investigations
- How do we define a Deviation?
- What are the different types of Deviations and how do we identify them?
- Steps to conducting a successful Investigation
- The do’s and don’ts to Investigation Interviews
- 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