EU IVDR Internal Auditor Training
About This Course
This instructor-led two-day course provides practical instruction for auditors undertaking internal and supplier audits for the European In Vitro Diagnostic Regulation (EU IVDR). The course describes the regulation for auditors and provides practical instruction for planning and conducting audits based on our EU IVDR audit model, which has consistently received great feedback.
Gain valuable knowledge on the changes and the key difference between IVDR and IVDD and the notified body review process for the IVDR.
This course includes a two-hour eLearning prerequisite, EU IVDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers all aspects of the regulation and identifies key topics and changes, including the economic operators and new roles associated with the EU IVDR, standard requirements that must be met by all IVD manufacturers, and pre- and post-market requirements of conformity assessment.
Key Learning Objectives
At the end of this training, you will be able to:
- Plan and conduct internal and supplier audits against the requirements of the EU IVDR
- Identify key articles and annexes of the EU IVDR
- Recognize the intent of requirements as described in recitals
- Identify classification implementation and classification rules
- Identify general safety and performance requirements (GSPRs)
- Recognize content of technical documentation
- Identify post-market surveillance reporting and vigilance obligations
- Recognize one EU IVDR audit model
- Plan an EU IVDR audit
- Document nonconformities against EU IVDR requirements
Who Should Attend
This EU IVDR internal auditor course is helpful for experienced internal auditors seeking to expand their auditing knowledge to the EU IVDR. Students should have some internal audit experience, and ideally have lead auditor qualifications in QMS audits.
Course tutors can include:
Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.
James Pink - James Pink has over 20 years of experience in the medical devices industry including 10 years as a health care technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. Mr. Pink is a contributor to several medical device standards committees including ISO 13485, ISO 14971 and various product-related standards.