Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products
October 20 - 22, 2014 - Malvern PA USCenter for Professional Innovation and Education, Inc.
info@cfpie.com
Phone:(610) 688-1708
This course is designed to provide participants with an understanding of the parameters for regulatory compliance, successful approaches to compliance, and meeting the concerns of regulators. Attendees will leave with a comprehensive set of tools for preparing regulatory initiatives, coping with challenges, and managing compliance. Additional benefits of this class include: •FDA authority and processes including 483s, Warning Letters, recalls, and other potential actions •Update on FDA electronic submission procedures •The benefits of a quality management system beyond the manufacturing environment This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.