Is data integrity a problem at your firm? Join the NJ/NY RAPS Chapter and speaker Andrea E. Chamblee, Esq, RAC, FRAPS as we discuss why data integrity is important, signs of lapses and conventional and unconventional consequences which the agency can impose if it suspects data integrity issues.
Andrea Chamblee is an adjunct associate professor at George Washington School of Medicine and Health and Johns Hopkins University. Her experience at FDA, starting in1987, includes work in the Chief Mediator and Ombudsman’s office and the Division of Compliance Policy in the Office of Regulatory Affairs, specializing in enforcement and compliance, product quality for drugs, biologics, devices, dietary supplements and combination products. She spent 10 years in the private industry from 1999 to 2009 before returning to FDA where she currently works at the Office of Regulatory Affairs, Office of Strategic Planning and Operational Policy, Food and Drug Administration as a senior regulatory counsel.
This event is sponsored by the RAPS New York/New Jersey Chapter and is intended to facilitate networking and knowledge sharing among area regulatory personnel. Light refreshments will be available for all attendees. RAC holders may claim two RAC recertification credits.