Best Practices for Deviation Investigations
Duration: 90 Minutes
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using documents, interviews, and objective evidence to arrive at a root cause and a corrective and preventative action plan.Learn how to identify and classify deviations for easier management and investigation.
Objectives of the Presentation
Why Should you Attend
- Describe what types of deviations exist
- Explain how to conduct a proper investigation
- Learn new tools for proper root cause analysis
- What things to avoid during the investigation
- How to properly document and manage the deviation details
- How to close the deviation and assess impact to the final product.
FDA, EMA, and other international regulatory agencies require that there be a deviation investigation system as a subsystem of a company's overall quality system. Those involved in performing investigations, review and acceptance of non-conformance investigations, will learn how to conduct investigations, dos and don'ts in interviews, how to determine CAPA and more in this webinar.
Who can Benefit
- Review of regulatory requirements for investigations
- What is the definition of a Deviation?
- Types of Deviations/identification of Deviations
- Conducting the investigation
- Interviews - dos and don'ts
- Source Documents/Evidence
- Determining root cause and effective/sustainable CAPA
- Key elements of the investigation report
- Mid-Level Managers
- Compliance Officials
- Manufacturing Personnel
- Laboratory Personnel