Facilities and equipment represent one of the six major segments of the Quality System identified by the FDA as areas of focus for GMP inspections. They represent the major capital cost associated with drug substance and drug product manufacture.
In addition to associated financial value, facilities and equipment are critical to establishing and maintaining product quality by ensuring process, environmental and material control. Associated risks must be understood and controlled in order to reliably achieve product quality.
Over the course of the asset life-cycle, different risks may be recognized and assessed. Control or mitigation strategies at each stage of the life-cycle are essential to continuous delivery of a quality product.
This course will explore the application of risk-based strategies to most effectively manage the entire life-cycle of facility and equipment assets in GMP manufacturing. Discussions will begin with design and the relationship of facilities and equipment to product quality. It will progress through the entire life-cycle from start-up, qualification, operation, maintenance and, finally, to retirement.
Emphasis will be placed on rationale for determining risk and methodology to control or mitigate it. Focus will be directed toward real risk to product quality and the application of best practices to ensure both technical control and oversight by the Quality unit. Regular re-evaluation and continuous improvement will be discussed.
The course will be lecture-based and will be structured to provide an open and interactive environment wherein all participants will contribute to the learning experience of the entire group.
Who Should Attend
The following individuals will benefit from this course:
- Engineering and maintenance professionals responsible for the design, construction, commissioning, qualification and asset life-cycle management of GMP manufacturing facilities and equipment
- Validation and technical experts responsible for overseeing and advising on GMP design and qualification requirements
- Quality assurance personnel responsible for reviewing, approving and overseeing quality systems associated with facilities and equipment
- Personnel responsible to operate and monitor production facilities and equipment