Successfully Investigating Deviations

Successfully Investigating Deviations is dedicated to fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause.

Topics

• What is the definition of a Deviation?
• Review of FDA and Regulatory Requirements for Investigations
• Conducting the Investigation
• Types of Deviations/Identification of Deviations
• Source Documents/Evidence
• Interviews – do’s and don’ts
• Key Elements of the Investigation Report
• Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations

Who should Attend

• Reviewers and Approvers of Deviation Investigations
• Deviation Investigators
• Regulatory Affairs Departments
• Quality Assurance Departments
• Compliance Auditors
• Quality Control Departments