The FDA QSR?
The FDA Quality System Regulation includes the
requirements related to the methods used in, and the facilities
and controls used for, designing, manufacturing, packaging,
labeling, storing, installing, and servicing of all finished medical
devices intended for human use. The QSR is designed to provide
manufacturer’s of finished medical devices with a framework of basic
requirements to use in establishing a quality management system
appropriate to the devices designed and manufactured and the
manufacturing processes employed. The principles embodied by the
regulation have been accepted worldwide as a means of ensuring that
acceptable products are produced.
This Course is for you if:
- You manufacture or would like to manufacture medical devices for sale in the U.S. and you need to understand the quality system regulations affecting these devices.
- You are responsible for managing, implementing, and/or adhering to a quality management system compliant with the FDA Quality System Regulation.
- You would like to understand the quality system regulation requirements and their significant impact on your organization.
$400 per person (5 person min)
$350 each additional over 5
What is CGMP or FDA QSR?
Internal Company Benefits
Key Terms and Definitions
QSIT Program Results
Four Major Themes
- Design Controls
- Production & Process Controls
- Corrective & Preventive Action
Interrelation Between Sections
Establish & Maintain Procedures
Executive Management’s Role
1998 FDA Statistics