Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions 2018

Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions 2018 is an event dedicated to basic steps of a deviation investigation and learn how to identify and avoid potential pitfalls during inveatigations.

Topics

• What is a Deviation?
• Overview of Regulatory Requirements for Investigations
• Deviation Investigation Process Model
• Types of Deviations/Identification of Deviations
• Conducting the Investigation/Investigation Principles
• Immediate Containment/Immediate Impact
• Source Documents/Evidence
• Interviews
• Key Elements of the Investigation Report
• Determining Root Cause and CAPA

Who should Attend

Attendees from:

• Reviewers and approvers of deviation investigations (e.g. Dept. Heads, Quality Assurance)
• Deviation investigators
• Regulatory Affairs staff and management
• QA staff and management
• Compliance auditors
• QC staff and management