INTERNAL AUDITS ACCORDING TO EU IVDR 2017/746 24.02./21.04./20.05./21.06./20.08./20.09./22.10./22.11./07.12.2021

Date: Multiple dates available below
Time: 8:30 AM to 5:30 PM (Central European Daylight Time GMT + 2)

(To calculate the correct time zone, please feel free to use the button “Time zone converter” and use Berlin as a reference European Time)

Duration: 8 hours
Location: Virtual Event
Language: English
Fee: 999 €

Description:

The Auditing Management Systems allow economic operators of in vitro diagnostic devices to drive an activity across the entire audit workflow from planning to reporting. In this training, the background of the Auditing Management System including the principles of auditing, managing an audit program, conducting management system audits, and evaluation of competence of the individuals involved in the audit process will be introduced to you.
Within 8 hours, you will receive a comprehensive summary concerning the fundamentals of the Auditing Management and the potential advantages of adhering to the program. Furthermore, you will receive practical examples of how to write the audit report and of typical In Vitro Diagnostic Regulation (IVDR) nonconformities.

Topics:

•Opening remarks
•Introduction
•Types of Audits
•Auditing Principles
•Managing and Audit Program
•Conducting an Audit
•Competence and Evaluation of Auditors
•Audit Sampling and Non-conformity identification
•Practical examples
•Q&A session
•Closing remarks

Schedule:

  • Start 08:30 AM – End 05:30 PM. Attendees are recommended to login 15 min in advance.

In order to keep the training interactive, the exact content schedule cannot be provided

Certification:

Personal Certificate will be provided in PDF

Presentation:

Presentation will be provided in PDF

Book now:

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