Date :
Place : United States, Clyde
Website :https://worldcomplianceseminars.com/
Contact Person:WCs Conference
Description:
Deviation investigations 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 could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.Deadline for abstracts/proposals : 11th February 2021
Organized By :WOrldcomplianceseminars
Keynote Speakers : Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance.
Conference Highlights :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 Source Documents/Evidence Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations Key Elements of the Investigation Report
Check the event website for more details.