A Comparison of ICH Q-10 Quality System and the FDAâ€™s Quality Systems Approach (QSA) to the Pharma (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: May 05, 2011||End Date/Time: May 05, 2011|
The ICH and FDA guidance documents on Pharmaceutical cGMPs stress the importance of management's responsibility to meet customer needs by encompassing quality improvement through quality by design (QbD), risk management, process control, and user feedback and experience.
This new paradigm forces industry leaders as well as the FDA to rethink their roles in this dynamic regulatory-business environment. Here, quality principles trump the dictates of compliance. If your company fails to respond to this new calling, it may not be able to compete effectively in the marketplace. These quality concepts are based on well-known and tested quality principles that have been shown to be effective. While the "new quality" is gaining, the virtues of compliance are declining.
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