EAS presents a one and one-half day intensive program discussing FDA’s current Good Manufacturing Practice requirements and recent inspection findings for human OTC drug products. The course will cover the FDA regulations Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century, Quality Risk-and Science-Based Approaches, Pharmaceutical Development and Pharmaceutical Quality Systems. Participants will gain an understanding of cGMP requirements and FDA’s enforcement of the regulations. FDA issues of concern will be highlighted throughout the seminar with emphasis placed on recent FDA regulatory and administrative actions. FDA investigator observations, as well as problems in dealing with FDA inspections, will be illustrated in the case studies presented.
At this Seminar You Will:
- Learn the requirements of the regulations.
- Gain an understanding of how FDA is enforcing the regulations.
- Receive detailed practical guidance on how to apply these requirements.
- Be given an opportunity to demonstrate your understanding of GMPs in case studies
- Be coached on how to prepare for an FDA inspection and how to avoid receiving a List of Objectionable Inspection Observations (Form FDA 483) at the end of an FDA inspection.
Finally, there will be a discussion of responding to FDA 483s and Warning Letters.