Stay Connected with Our Expert Team

News & Events

Stay Current. Contact Us Today.

Jack Garvey to Moderate Data Integrity Enforcement and Risk-Reduction Webinar on February 15, 2018

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.

Long time friend of the firm Norm Howe just invited Managing Partner Jack...