Date: 3rd July, 2008
Location: web seminar series, USA
Summary:Clinical, Cosmetic, Pharmaceutical, Water - Training
What do cGMP regulations and quality management systems have in common? Nothing and everything. They differ somewhat in organization and certain fundamental elements, yet share basic principles at the same time. The regulations specifically assign the quality unit as the authority to create, monitor and implement a quality system, with quality management emphasizing quality assurance and the use of risk management tools, in addition to quality control.
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 company's position with regards to the material presented.
Learning Benefits of 3-Session Series:
- How to determine compliance with applicable cGMP requirements
- Explore the concepts of modern Quality Management Systems
- Learn about the FDA's two surveillance inspectional options
- Discover the impact of the FDA Modernization Act of 1997 (FDAMA)
- Learn about the Six-Systems inspection approach
- Keys to model administration and the implementation process
Part 1 (July 3, 2008) Discussion Points:
The Quality Unit and FDA Guidance
Quality Risk Management
CAPA (Corrective and Preventive Action)
Change Control (Quality Planning and Revision)
Part 2 (July 17, 2008) Discussion Points:
Six-Systems Inspection Model
Gap Analysis & Process Mapping
Management Responsibilities
Part 3 (July 31, 2008) Discussion Points:
Overlap of QMS and cGMP Regulations
FDA Inspection Strategies
Compliance Guidance
