A Quality Management Systems Approach to Pharmaceutical cGMP Regulations and Inspections
|Event Date/Time: Jul 03, 2008||End Date/Time: Jul 31, 2008|
A comprehensive quality management model enables pharmaceutical manufacturers to support and sustain robust, modern quality systems that complement cGMP regulations. However, several key concepts are critical for any discussion of modern quality systems. These concepts include the elements of the comprehensive model and how they relate to the manufacturing of pharmaceutical products, the relationship between the elements of this model and cGMP regulations, and finally the implementation of the six-system inspection approach, which requires a significant investment of time and an appropriate allocation of resources.
This live and comprehensive 3-session series will provide the fundamentals for the quality system model and the six-system inspection approach. The sessions, taking place on July 3, July 17 and July 31, 2008, have been spread out over two-week intervals to allow participants the ability to internalize the interrelationships within the model and evaluate their companyâ€™s position with regards to the material presented.