Learn about the FDA’s Quality System Regulations (QSR) as they apply to the requirements and manufacturing quality of nationally and internationally commercialized products with a specific focus on the practice and implementation of a compliant Quality System. These principles are demonstrated using the US FDA Code of Federal Regulations (21 CFR) and International Standard Organization (ISO) documents. Topics include the areas as follows: the quality system requirements; design controls; document and purchasing controls; identification and traceability; production and process controls; acceptance activities; nonconforming product; corrective and preventative action; labeling and packaging controls; handing, storage, distribution, and installation; records; servicing; and statistical techniques. Documentation, record keeping, and how these issues affect medical device product quality and patient safety and the regulatory responsibilities therein will also be addressed. The FDA Quality System Inspectional Technique (QSIT) will also be covered to address the practical applications of the FDA medical device manufacturing requirements and the conduction of FDA inspections. The course is designed to provide a basic understanding of 21 CFR 820 and ISO 13485:2003 including similarities and differences.
This course can be applied towards:
Noncredit courses do not produce academic credit nor appear on a Colorado State University academic transcript.
The final class meeting will be held on Tuesday, May 28 (due to the Memorial Day holiday on Monday, May 27).
Lori Carr, President and CEO of Lori A. Carr, Inc., is a Principle Consultant in the Medical Device regulated industry and has 17 years of experience in this field. In her Regulatory Affairs consulting practice, including mock FDA inspections/audits, gap analysis, and compliance remediation activities associated with all aspects of medical device manufacturing, she brings 13 years of FDA Medical Device Specialist/Investigator experience.
Lori began her FDA career in 1994 in the Cincinnati District Office and transferred to the Denver District Office in 2001 as a Medical Device Specialist. In both FDA locations, she acted as the FDA Medical Device Registration Monitor and was also a member of the FDA Foreign Inspection Cadre for Medical Devices in which she conducted foreign Good Manufacturing Practice (GMP) and Quality System Regulation (QSR) inspections for routine, premarket (including 510(k) and PMAs) and postmarket inspections. Lori was an FDA Level II Certified Medical Device Investigator which is a special honor that was bestowed on FDA Investigators that were able to demonstrate competence in conducting inspections in the Medical Device Program area.