The Tougher U.S. FDA - One Year Later (FDA)
Venue: Online Event
|Event Date/Time: Oct 19, 2010||End Date/Time: Oct 19, 2010|
Why Should You Attend:
The major shift in the emphasis of U.S. FDA to a "tougher" regulatory / CGMPs climate affects all regulated companies. This change in focus has a major impact on individual company compliance objectives, efforts and measurements of success. What has the industry seen after one year of this changed emphasis? How has the changes translated themselves into actions? Based on the last year, what are reasonable expectations for the near term, and further out in the future. Will these changes ever revert back? We will evaluate the chief areas of these FDA regulatory / CGMP compliance changes or new emphasis to see how this translates into future FDA expectations and how such actual and anticipated changes are resulting in a new regulatory climate.
Areas Covered in the Seminar:
- Stated expectations and the one-year result.
- Avoid complacency from past "good" FDA actions.
- Avoid complacency from just completed "good" ISO feedback.
- FDA's desired responses from industry.
- How to respond now -- where to shift focus first.
- Where to direct scarce resources.
- Anticipated future directions.
- Maintain 'the edge'.