Best Practices for Investigating Deviations
OVERVIEW Deviation investigations are a very common topic to be reviewedduring FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls. WHY SHOULD YOU ATTEND Proper root cause analysis of the issue is necessary to make sure that the firm is focusing on the real problem and subsequently the proper corrective and preventative actions can begin. This webinar will help attendees understand how to use root cause analysis tools and CAPA plans to successfully resolve deviations and non-conformances. Deviation Investigations Training Program AREAS COVERED Review of FDA and Regulatory Requirements for Investigations What is the definition of a Deviation? Types of Deviations/Identification of Deviations Conducting the ...