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. Having deviation investigation procedures is not enough– it is the content and conclusions of those investigations that truly count. A proper root cause analysis, where one gathers evidence and ensures a sustainable corrective action, is key to a 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.
At the conclusion of this interactive session, you will be able to:
- Outline investigation regulatory requirements
- State the true definition of a deviation
- Identify deviations and their characteristics
- Describe how an investigation would be conducted
- Outline the dos and don’ts of interviews
- Explain source documents and evidence that pertain to RCA investigations
- Determine root cause and effective, sustainable CAPAs
- Identify key elements of an investigation report
Additionally, this course will use real-world examples, enabling you to practice what you’ve learned and leave the session with reference for future use.