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It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis on proving a company is "in control" to an investigator's satisfaction, which has to center on CAPA. So the webinar will address the development of a new, or revision of an existing CAPA SOP to ensure it meets those goals.
Why should you attend: The U.S. FDA has recently declared a goal of "getting tough on CGMP compliance / enforcement", together with mandating better science as a foundation. They've supported this with increased hiring of investigators. Since CAPA failings are a major problem in compliance, and is a key to voluntary and meaningful compliance, this is one of the areas to come under this increased FDA scruinty. Recent high profile negative publicity on pharmaceuticals, devices, as well as events in unrelated industries have put pressure on the Agency to be more aggressive, and should be a wakeup call to industry to improve their CAPA systems, and then promptly respond to what CAPA "tells" them. Contrary to regulated industry's perceptions, the public often sees this industry in a bad light, and .wants change. Congress is starting to listen.
Areas Covered in the Session:
- Basic Requirements
- Shifting and New Emphasis
- Core Expectations
- High Risk Areas
- The Key CAPA Modules; plus CARs and Logs
- 12 "Must Haves"
- Consistent Definitions
- "Closing the Loop"
Who Will Benefit:
- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations