June 13, 2019 at 1:00 pm eastern
Presented by Bryan Coleman, EAS Senior Director for Drugs and Medical Devices
With more than 80 therapeutic categories, Over-the-Counter (OTC) drug products play an ever-increasing role in health care. FDA’s Center for Drug Evaluation and Research (CDER) working in conjunction with the Office of Regulatory Affairs (ORA) ensures that OTC products are safe to use, appropriately labeled, adverse events reports are filed and that all products are manufactured under the appropriate quality control measures. Generally, the FDA’s first and best opportunity to assess the quality and compliance conformance of an OTC drug will be during an on-site inspection of the manufacturing facility. From a Good Manufacturing Practices (GMP) perspective, manufacturers must recognize that the FDA applies the same, stringent 21 CFR 210 and 211 drug GMP standards to OTC products just as prescription drugs are held to. Thus, OTC drug manufacturers (and contract manufacturers) must maintain vigilance at all times with all aspects of production quality and documentations. From the physical plant and grounds, employee training, testing and specifications, including Out of Specifications (OOS) results management, compliance expectations with 21 CFR 211 are clearly articulated. Register
About the Presenter
Join Bryan Coleman, EAS Senior Director for Drugs and Medical Devices for a complimentary webinar on June 13, 2019 at 1:00 pm eastern where he will discuss the specifics of GMP compliance under 21 CFR Part 211 and common pitfalls that warrant increased FDA attention.