What are the complexities, nuances, and considerations in establishing a compliant, effective, and practical quality management system for combination products? Integrating two types of quality systems to comply with FDA combination product regulations can be overwhelming. Come and enhance your understanding of the requirements for combination products. Learn the key concepts of an integrated Quality Management System for drugs and medical devices to ensure a happy marriage between the two.
· How does FDA decide whether more than one medical product used together is a combination product?
· What does a streamlined QMS mean?
· How can the QMS processes be adapted to integrate medical devices and pharmaceuticals to develop combination products?
Audience: Experienced Professionals, but all are invited to attend
Date: Thursday, June 22nd
Time: 6:00 pm CST – 8:00 pm CST
Location: St. Cloud State - Plymouth 9750 Rockford Road, Plymouth MN
Cost: Minnesota ASQ & RAPS Members - $20.00
Non-Members - $40.00
- Certificates of Completion: Issued via email, after workshop completion, for .2 ASQ RUs or CEUs.