FDA Training Modules on MDSAP

FDA has prepared 10 training modules on the Medical Device Single Audit Program (MDSAP). The modules are available through CDRH Learn at http://www.fda.gov/Training/CDRHLearn/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Open the dropdown for Postmarket Activities and look for Inspections – Global Harmonization.

In addition to a Primer by Kim Trautman, the 10 modules are:

1. Introduction to MDSAP
2. MDSAP Management
3. MDSAP Device Marketing Authorization and Facility Registration
4. MDSAP Measurement, Analysis, and Improvement
5. MDSAP Medical Device Adverse Events and Advisory Notices Reporting
6. MDSAP Design and Development
7. MDSAP Production and Service Controls, part 1
8. MDSAP Production and Service Controls, part 2
9. MDSAP Production and Service Controls, part 3
10. MDSAP Purchasing