In 2017, more than 60% of FDA warning letters cited data integrity issues. Potential regulatory risk from data integrity problems extends far beyond laboratory notebooks and computer system audit trails. This must attend webinar will delve into critical data integrity considerations, including FDA’s new warning letter language and the expectation it creates for manufacturers; the Application Integrity Policy (AIP) – the original remedy for data integrity issues; and clinical data management problems across clinical data contract service providers and how to adequately address these problems. Attendees will hear from two of FDA’s leading experts on data integrity, along with industry experts who have deep knowledge in resolving data integrity challenges. Attendees will have ample time to ask questions of the panelists – including FDA.
Sarah Barkow, Lead Consumer Safety Officer, Management Quality Guidance and Policy Staff, Office of Manufacturing, CDER, FDA
Jamie Colgin, President, Colgin Consulting, Inc.
Paula Katz, Director, Manufacturing Quality Guidance and Policy Staff, Office of Manufacturing, CDER, FDA
Michael A. Swit, Partner, Law Offices of Michael A. Swit
Moderated by Jack Garvey, Founder and CEO, Compliance Architects LLC