Lead Auditor

AAMI’s 2-day Lead Auditor course teaches participants the requirements of and how to utilize ANSI/AAMI/ISO 13485. Participants will understand best practices of auditing quality managements systems as defined in ANSI/ISO 19011.

 

Course Details

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

Learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and the international quality management standard, ANSI/AAMI/ISO 13485:2016.

  • September 15 to 16, 2020 Virtual Only-USA EST Register
  • September 7 to 11, 2020 Virtual Attendance Only Register
  • September 21 to 25, 2020 Virtual Only-USA EST Register

Design Control Requirements: Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485

Benefit from an intensive focus on design control requirements for the FDA’s Quality System Regulation, the international standard ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.

    • September 21 to 23, 2020 Virtual Attendance Only Register
    • September 30 to October 2, 2020 Virtual Only-USA EST Register
    • December 15 to 17, 2020 Arlington, VA Register

    Process Validation Requirements and Industry Practice

    Obtain practical tools and techniques for process validation requirements for the FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force. 

     

    Course Details

    • August 10 to 12, 2020 Virtual Attendance Only Register
    • September 28 to 30, 2020 Virtual Attendance Only Register