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.
Successfully Investigating Deviations covers topics such as:
- 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
Successfully Investigating Deviations brings together:
- Reviewers and Approvers of Deviation Investigations
- Deviation Investigators
- Regulatory Affairs Departments
- Quality Assurance Departments
- Compliance Auditors
- Quality Control Departments
