Compliance and Product Quality
Detailed discussion on regulatory actions, recalls and product deviation reports associated with inspections.
Inspections of CBER Regulated Products
Overview discussion on types of inspections, inspection teams, scope and coverage, and outcomes of an inspection.
CBER’s Bioresearch Monitoring Program: Clinical and Nonclinical Inspections
Overview of the Bioresearch Monitoring (BIMO) program at CBER, covering Good Clinical Practice and Good Laboratory Practice compliance as it relates to human subject protection, clinical trial data, and inspections.
Division of Biological Standards and Product Quality (DBSQC)
Discussion of the activities within the Division of Biological Standards and Product Quality and its testing laboratories, as part of the Office of Compliance and Biologics Quality. Discussion includes quality systems, product testing, lot release, reference reagents and physical standards, and method validation.
CBER’s Lot Release System: Overview of the Current Process
Detailed discussion of the receipt, processing and release of product lots via the lot release system, within the Division of Manufacturing and Product Quality, which includes review and testing.