FDA CERSI Lecture Series, MDSAP Pilot
CERSI Lecture Series
WHAT: Lecture series to present current research and advancements in regulatory science related to pre-clinical evaluation of safety and efficacy of medical products, emerging technologies, and assessing diverse data sets through information sciences to improve health outcomes.
WHO: Centers of Excellence in Regulatory Science and Innovation
HOW: Presented by scientists from the CERSI academic institutions or collaborators of CERSI investigators.
Medical Device Single Audit Program (MDSAP)
WHAT : Invitation to manufacturers to participate in innovative regulatory single audit program.
WHO: MDSAP Regulatory Authority Council
HOW: Learning modules in CDRH Learn – see links below
Inspections – Global Harmonization (New modules 9/8/16)
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