Seminar - Online
FDA has found and reported about multiple cases where companies manipulated electronic records. Since then FDA inspectors have focused inspections on security, availability, accuracy and integrity of 'complete' records. FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors. Just in the last three years FDA issued over 30 warning letters and 483 form inspectional observations related to electronic records. The industry is unsure how to comply with FDA inspection requirements. Because of missing clear guidance from the FDA the industry has lots of questions. Using recent warning letters as examples, this seminar will demonstrate how current data integrity requirements will be identified, implemented and documented.
Wednesday, May 20, 2015 (13:00 - 14:00)
Mississauga, Ontario 44813, Canada
Phone: 4169154458
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