Over the last several years, FDA Form 483 observations and warning letters have outlined industry problems with process deviations and the subsequent Root Cause Analysis (RCA) investigations that follow. Since a failure to adequately investigate deviations leads to more problems, firms caught in this free-fall experience continual problems and loss of profits. Therefore, having a procedure on Deviation Investigations is not enough…it is the content and conclusions of those investigations that truly count. Doing a proper root cause analysis, gathering evidence and ensuring a sustainable corrective action is key to a proper deviation investigation. Fortunately, there are several time and cost-saving steps you can take to ensure bullet-proof investigations.
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 (CAPA). Learn how to identify and classify deviations for easier management and investigation.
Join our interactive online training course where you will learn:
- Review of regulatory requirements for investigations – What you must know!
- What is the true definition of a deviation?
- Types of deviations and how to identify them
- Conducting the investigation: Putting what you’ve learned into practice
- Interviews – dos and don’ts
- Source documents/evidence
- Determining root cause and effective, sustainable CAPA
- Key elements of the investigation report
In addition, this course will use real-world examples to illustrate points and provide reference for attendees.