ASQ CERTIFIED MEDICAL DEVICE AUDITOR (CMDA) REFRESHER COURSE
Offered by San Gabriel ASQ
Saturdays - March 15 – May 24
Instructor Upen Patel will cover key topics related to ASQ’s Certified Medical Device Auditor (CMDA) body of knowledge through then (10) Saturday sessions.
Topics covered include: Auditing Fundamentals, Auditing and Inspection Processes, US Laws: QSR: CFR Title 21, U.S. requirements (FD&C Act), QSR, EU MDR, Health Canada, Other international agencies, International Standards, Validation, Risk Management, Restriction of Hazardous Substances (RoHS), Human factors and usability engineering, Biological evaluation, Packaging, Device Shelf Life, Controlled Environments and Utility Systems, Sterilization, Software Development and Maintenance, Quality Tools and Techniques, Process capability, Six Sigma, Lean Tools, Cost of Quality (COQ), and Sampling.
Cost is $399 for ASQ members or non-members. View more details and register here.