EGLL 4094 - Quality System and ISO 13485 Regulations

Learn about the FDA's Quality System Regulations (QSR) as they apply to the regulation and quality manufacturing of nationally and internationally commercialized products with a specific focus on the practice and implementation of design controls.These principles are demonstrated using the CFR and FDA and ISO documents. Topics to include the quality system requirements, design, document and purchasing controls, product and process controls, corrective and preventative action, labeling and packaging controls, handling, storage, records, servicing, and statistical techniques as well as documentation and how these affect product quality and patient safety.

This course can be applied towards:

• Regulatory Affairs Certificate

Noncredit courses do not produce academic credit nor appear on a Colorado State University academic transcript.

Important Information

Class will meet in Routt Hall on May 7. The final class meeting will be on Tuesday, May 29 (due to the Memorial Day holiday), in Room 103 of the Behavioral Sciences Building.

Instructors

Lori Carr

Lori Carr is 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. 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. Lori's Professional Certification include the Regulatory Affairs certification (RAC/US) through the Regulatory Affairs Professionals Society (RAPS) and Certified Quality Auditor (CQA) through American Society for Quality (ASQ). She also holds a BS degree in Chemistry from Xavier University in Cincinnati, Ohio.