Jack Garvey, Compliance Architects® founder and CEO, will be moderating an FDLI-sponsored webinar on February 15, that will delve into a variety of data integrity considerations, including FDA’s new Warning Letter language and the Application Integrity Policy (AIP).
The discussion panel will include two leading data integrity experts from FDA: Paula Katz, Director, Manufacturing Quality Guidance and Policy Staff, Office of Manufacturing, CDER; and Sarah Barkow, Lead Consumer Safety Officer, Management Quality Guidance and Policy Staff, Office of Manufacturing, CDER. Data integrity remains a significant focus area for the Agency; in 2017, more than 60% of FDA warning letters cited data integrity issues. Advanced registration for the webinar is required.
More information including the registration for the session can be found here.
