Webinar: 3 Hour Virtual Seminar- Best Practices for Deviation Training When: Wednesday, Apr 21, 2021 - 11:00 AM Duration: 03 Hours
Deviation investigations and CAPAs are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations or ineffective CAPAs could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.
Objectives Of the Session:
Outline the requirements of the Deviation and procedure including the deviation report
Choose the most appropriate Root Cause Analysis methods for the situation
Discuss how to conduct the deviation and the tools to be used in the process
Areas Covered in this Session:
Review of FDA and 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
•Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations