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 are responsible for developing, implementing, maintaining or adhering to a quality management system compliant with the FDA Quality System Regulation.
- You would like to understand the quality system regulation requirements.
- You have been asked to become part of the internal audit team and need to understand the Quality System Regulation requirements.
$2000 for up to 12 persons
$250 each additional
What is CGMP or FDA QSR?
Internal Company Benefits
Key Terms and Definitions
Three Basic Categories
- Management Responsibilities
- Company-Wide Activities
- Specific Requirements
Interrelation Between Sections
Establish & Maintain Procedures
What to Expect From Auditors
Generic Auditor Questions