Good Manufacturing Practices
October 8 - 10, 2014 - Malvern PA USCenter for Professional Innovation and Education, Inc.
info@cfpie.com
Phone:(610) 688-1708
Good Manufacturing Practice regulations (cGMPs) apply to pharmaceutical, biotech and medical device products regulated by FDA. This course explores the content and interpretation of the regulations, with emphasis on the necessary practices, procedures and documentation required to achieve full compliance. The course will utilize case studies to facilitate interpretation and application of regulations. The attendees will gain understanding of how knowledge of the regulations facilitates efficient and cost effective issue resolution. The first day of the course introduces students to the Food Drug and Cosmetic Act, principles of pharmaceutical GMP regulations and navigating FDA enforcement. The second further examines application of GMP regulations in the pharmaceutical and biotech industries, medical device quality system regulations, and review of case studies for the practical application of regulations. The third day details the controls and process that enable effective quality management with emphasis on establishment of quality systems, management responsibilities, handling deviations and techniques for auditing and monitoring of processes to ensure ongoing compliance. 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.