Pharmaceuticals 2011 - A Comparison of ICH Q-10 Quality System and the FDA’s Quality Systems Approach (QSA) to the Pharmaceutical cGMPs

Why Should You Attend:
The QSA to Pharmaceutical cGMPs and ICH-Q10 are guidance documents that stress the importance of management's responsibilities to meet customer needs by encompassing quality improvement through quality by design QbD), risk management, process control, and user feedback and experience.

This 4 hour course will provide the attendees with the knowledge and insight required to understand and apply the principles and concepts of ICH ?Q10 and the Quality Systems Approach. This new paradigm forces industry leaders to rethink their roles in meeting corporate objectives and strategies.

It challenges the FDA to focus on the importance of user requirements and assessing results with less importance on compliance to inflexible rules and regulations. The key message is Senior Management must be actively involved in quality operations because it is they who have the authority and responsibility to control and demand that corrective action be taken to ensure quality issues are addressed openly and effectively.

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