EU MDR Internal Auditor Training
About This Course
Learn how to prepare for the changes from the MDD to the MDR, including audit program management and how to prepare internal audit plans and address gaps during the audit. This course also focuses on ISO 13485:2016 relative to the EU MDR and how companies can be prepared.
This instructor-led two-day course provides practical instruction for auditors undertaking internal and supplier audits for the European Medical Device Regulation (EU MDR). The course describes the regulation in depth from the auditor’s perspective and provides practical instruction for planning and conducting audits.
This course includes a two-hour eLearning prerequisite module, EU MDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key topics and changes, including the economic operators and new roles associated with EU MDR, standard requirements that must be met by all manufacturers regardless of class, and the pre- and post-market requirements of conformity assessment.
Key Learning Objectives
On completion of this EU MDR internal auditor course, you will be able to:
- Plan and conduct internal and supplier audits against the requirements of the EU MDR 2017-745
- Identify conformity and non-conformity against the specific articles and annexes of the regulation
- Describe correspondence between the EU MDR, ISO13485:2016 and a typical medical device manufacturer’s QMS
- Select appropriate samples of audit evidence to determine compliance
- Recognize the primary elements of the European Medical Devices Regulation 2017/745 (EU MDR)
- Recognize specific requirements relative to manufacturer obligations
- Identify one strategy for conducting an internal audit against the EU MDR
- Plan a manufacturer audit against the EU MDR
Who Should Attend
This course is helpful for experienced internal auditors seeking to expand their auditing knowledge to the EU MDR. Students should have some internal audit experience, and ideally have certified auditor/lead auditor qualifications in QMS audits.
Course Tutors
Course tutors can include:
Janet Book - Janet Book has worked in the field of quality for over 35 years in various industries, including blood banking, food processing, quality consulting, chemicals, pharmaceuticals and medical devices, with both large and small companies.
She has conducted internal and supplier audits using many different industry-specific standards and regulations. She also has vast experience writing quality procedures, developing quality management systems, and developing and presenting quality-related training and seminars. Ms. Book is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and a RABQSA Quality Systems Lead Auditor.
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.
Additional Recommended Courses
CAPA Considerations: Problem Statement Writing and Investigation Techniques
Utilizing proven methodologies, this highly interactive medical device CAPA writing course provides learners
with the tools and skills needed to identify root causes of existing nonconformities from complaints, process deviations, audits and other feedback mechanisms.
This 2-day virtual instructor-led course covers how to effectively write concise, understandable problem statements and specific corrective action plans relative to problem statements. Learners are provided with instruction and guidance as they conduct hands-on medical device writing exercises, working through case studies of investigation data and summarizing key findings. Our highly experienced instructor will provide real-time feedback to help learners write concise medical device nonconformity statements.
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
- Define the purpose of Corrective and Preventive Action (CAPA)
- Identify and analyze data inputs for CAPA
- Compose a proper and complete problem statement
- Apply investigation techniques to identify root causes and define the appropriate corrective action
- Identify effectiveness criteria and perform an effectiveness check
- Recognize how to close the CAPA loop and the requirements to close CAPAs in a timely and complete manner.
Price: $1200.00
Medical Device Single Audit Program (MDSAP)
This virtual instructor-led one-day course covers the rationale for developing the Medical Device Single Audit Program (MDSAP), who the participating regulatory authorities are, and the specific audit criteria (including country-specific requirements) used during MDSAP audits.
This course discusses, in depth, the audit approach used by recognized MDSAP auditing organizations (AOs) as well as the MDSAP nonconformity grading system. Learners will also identify what MDSAP audit findings may trigger action from a participating regulatory authority.
This course pairs well as a prerequisite to MDSAP Internal Auditor Training (2 day).
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
- Discuss the Medical Device Single Audit Program (MDSAP)
- Evaluate the MDSAP Quality Management System (QMS) audit nonconformity grading system and recognize grades that may trigger regulatory follow-up
- Identify the IMDRF MDSAP requirements and documents in use
- Explain the MDSAP Audit Approach
Price: $800.00
ISO 19011:2018 - Applying Principles to Medical Device QMS Audits
This fast-paced instructor-led one-day course covers the basic concepts of planning, conducting, and reporting a medical device quality management system (QMS) audit in accordance with ISO 19011:2018. It is a must for auditors at all levels of the organization, as well audit program managers.
This course covers how to apply fundamental auditing strategies to any QMS scheme, as well as how to identify and grade nonconformities and prepare a medical device audit report in accordance with the identified criteria. The course also focuses on applying these fundamental principles when auditing a medical device manufacturer’s quality management system.
By the end of this training, you should be able to:
- Describe the purpose of:
- A quality management system
- Quality system standards
- Quality Management system audits
- Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011:2018
- Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with audit criteria (e.g., ISO 13485:2016)
Who Should Attend
This ISO 19011:2018 audit training is helpful for all auditors and all management personnel with responsibility for medical device regulatory life cycles, including involvement with the design and implementation of quality management systems or oversight of an internal or supplier auditing program.
Price: $800.00