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Office of Pharmaceutical Science (OPS) “Detail Rotation” visits to CDER and CVM Offices OPS has been a key contributor to FDA’s Pharmaceutical Inspectorate program in organizing, coordinating and conducting “Detail Rotation” visits to CDER and CVM Offices by Level III Drug Investigator candidates. The visitation program is offered to drug investigators as they continue their interactive training in FDA, with Center’s drug application reviewers and other officials who oversee drug manufacturing regulatory programs. The “Detail Rotations” occur after a candidate has completed Modules 1 to 7 of the PI curriculum at FDA’s Office of Regulatory Affairs University (ORA U). Total duration of a “Detail Rotation” in CDER and CVM Offices is typically four weeks. Key objective of the Detail Rotation in OPS Offices is to familiarize a Drug Investigator in greater depth with activities, processes and procedures involved in CDER’s review of new drug applications; about designing a new drug product, its development towards commercialization, quality specifications setting, assessment of manufacturing process design, and review of unit operations involved in drug product manufacturing. Many FDA initiatives and regulatory programs directed towards enhancing product knowledge and manufacturing process understanding, including life-cycle management of FDA regulated drug products are discussed with the visiting investigators. A “Detail Rotation” is developed after discussing the professional development needs of each of the visiting drug investigators, including their academic background and prior work experience. Customization of each offering is facilitated by the involvement of many persons in the Centers with diverse scientific, technical and regulatory experience, who serve as members of each Center’s Detail Coordination Group. After successful completion of a Detail Rotation, the drug investigator will become a member of FDA’s Pharmaceutical Inspectorate, as described in the PI Memorandum of Understanding. Since the first offering of the Level III Detail Rotation in June 2005, a total of 16 ORA Investigators and one CDER Compliance Officer/Investigator have completed the program, and three additional ORA investigators are at different stages towards their completion. The Detail Rotation program has facilitated extensive communication and interaction among the Agency’s review, regulatory compliance and field inspection staff. Each person who completed this program has commended it as a unique and rewarding experience, and has suggested that comprehensive information about FDA’s Center and Field interactions should be considered for inclusion in the earlier phases of an ORA Drug Investigator’s training.
Date created: February 6, 2006, updated January 28, 2008 |
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