Training: QMSR Transition — Preparing for FDA ISO 13485 Harmonization in the EU

by | May 7, 2024 | Upcoming Trainings

Speaker: Paige Sutton-Smith, Quality and Regulatory Affairs Manager

Date: June 13, 2024

Duration: 3 hours | 9:00 AM – 12:00 PM (US Eastern Standard Time), 3:00 – 6:00 PM (Central Europe Summer Time)

Virtual

A recording will be available to registered participants, in case they are not able to attend all the live sessions.

Training Objectives

  • Understand what has changed from QSR to QMSR
  • Plan how to update your QMS and TD in preparation for the change
  • What to expect from the FDA after implementation

Training Content

  • Review of the QMSR Final Rule
    • What has changed?
    • What is the same?
    • Impact on Inspections
  • Planning QMS Updates
  • Planning TD Updates
  • Implementation Timeline

Training Format

  • Presentation with interactive discussions
  • Exercises during the training
  • End-of-training assessment (participants will receive a training certificate)

Who Should Attend

  • Quality and Regulatory professionals
  • R&D, Engineering, and Design and Development professionals
  • Internal auditors

Price

EUR 355 including course material and certificate

Register