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Subscribe NewsletterMeeting Tougher U.S. FDA Expectations - Update
Product Id
:
600224
Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs.
It will examine how these goals of the Agency have translated into action in the past half year: The changing focus of QSIT re: medical devices and ICH Q10 re: pharmaceuticals; Multi-site company operations, and the supply chain; Trends evident in 483 observations and Warning Letters; Emphasis on proving a company is "in control" to an investigator's satisfaction; and proactive and reactive Warning Letter avoidance techniques.
It will examine how these goals of the Agency have translated into action in the past half year: The changing focus of QSIT re: medical devices and ICH Q10 re: pharmaceuticals; Multi-site company operations, and the supply chain; Trends evident in 483 observations and Warning Letters; Emphasis on proving a company is "in control" to an investigator's satisfaction; and proactive and reactive Warning Letter avoidance techniques.
Areas Covered in the Session:
- The Changed / Tougher FDA.
- Shifting and New Emphasis
- Core Expectations
- QSIT and Q10 Focus
- High Risk Areas
- The Supply Chain
- The Multi-Site Challenge
- What Constitues "Proof"
Who Will Benefit:
- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations