Faculty: Kelly Thomas | Code: FDB3097
Ensure regulatory compliance and maintain data integrity through effective auditing of laboratory data systems. Join our informative webinar, where we delve into the crucial aspects of auditing to meet the expectations of regulatory agencies. Gain detailed insights into the most common non-conformances and equip staff members, even those unfamiliar with laboratory computer systems, with a comprehensive understanding of the necessary controls to ensure the integrity of analytical data.
This webinar is designed to educate participants on the importance of correct data system configuration and provide guidance on what to look for during the audit process. By implementing the knowledge gained, businesses can effectively reduce the risk of regulatory action resulting from non-compliance with current expectations, safeguarding their operations and reputation. Don't miss this invaluable opportunity to enhance your auditing practices and align with regulatory requirements.
AREAS COVERED IN THE SESSION:
WHO SHOULD ATTEND:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.