Medpoint University

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Course Titles

  • Establishing a Quality System
  • Preparing for a Mock Audit
  • Writing a 510 (K)
  • Preparing a PMA
  • CMDCAS Training
  • The Role of an Ombudsman
  • Supplier Quality
  • An Overview of the FDA
  • Supplier Quality
  • MRB Process & Support
  • 21 CFR Part II
  • Adverse Event Reporting
  • Computer Validation
  • Risk Management
  • Responding to 483’s
  • CDT Submission
  • Product Labeling
  • CAPA
  • GMP’s
  • IVD’s
  • Writing SOP’s
  • Sterilization
  • QSIT for Devices
  • Clean Room Technology
  • Global Regulatory Strategy
  • Role of the RA Professional
  • Intro to RA
  • International Registrations
  • ISO 13485
  • QSR Regulations
  • IQ, OQ, PQ
  • Process Validation
  • MDR Reporting
  • Design Control
  • Electronic Submission Techniques

CEU Credits Available

Delivery Options:

Onsite

Private teleconference

Webinar

Costs: Call for details

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