Quality Assurance and Regulatory Affairs
Instructor: Dan Bracco, Oxford Immunotec
Working in a regulated environment can additional stress to an already rigorous environment. Gaining a better understanding of quality assurance and the regulatory process can lead to more company-wide understanding of why processes must followed without exception. During this two-day workshop, you will be exposed to the entire quality system:
Topics
- Defining the Quality System
- Modern Quality Control
- Structuring a Quality Department
- The Quality System Regulation (QSR)
- Compliance Issues
- SO 13485-2003
- FDA Overview
- Hosting an FDA Inspection
- The 510(k) PreMarket Notification Process
- Investigational Device Exemptions
- The PMA Process
- Reimbursement Strategies
- FDA Enforcement
- Corrections and Removals
- Promotion and Advertising
- In-Vitro Diagnostics
- Combination Products
- Medical Device Reporting
- Exporting Medical Devices, International Regulatory
For more information please contact Corporate and Professional Education at +1-508-831-5517, or e-mail us at cpe@wpi.edu.
