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
EU IVDR Internal Auditor
This virtual instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU IVDR. This course also focuses on ISO 13485:2016 relative to its correspondence with the EU IVDR.
This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union In Vitro Diagnostic Regulation (EU IVDR). The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning and conducting EU IVDR audits according to NSF’s formal, documented EU IVDR Audit Model.
This course includes a two-hour eLearning prerequisite module, EU IVDR – 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 pre- and post-market requirements associated with EU IVDR – standard regulatory requirements that must be met by all In Vitro Diagnostic manufacturers wishing to do business in the EU regardless of IVD classification.
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:
- Identify Key Articles and Annexes of the EU IVDR
- Recognize Intent of Requirements as Described in Recitals
- Identify Classification Implementing 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 course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU IVDR, for managers of audit programs, and for anyone who will be the subject of or participate in an EU IVDR audit. Delegates should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.
Price: $1200.00
Preparing for FDA Medical Device Inspections – Practical Guidance (Advanced)
Understanding what to expect during an FDA inspection enables a medical device manufacturer to prepare effectively for an FDA inspection. This course is designed to meet the needs of domestic and foreign medical device manufacturers doing business or intending to do business in the United States. This course focuses on group activities designed to identify the key elements of Level 1, 2, 3 and For Cause inspections; preparing for and hosting an FDA inspection; review FDA databases (MAUDE and Recall) to identify and understand the focus of an FDA For Cause inspection; review the preamble and QSIT Guide to understand how to prepare for an inspection of the primary subsystems contained in QSIT; develop effective FDA 483 responses; and prepare in advance information needed by the investigator to complete an EIR (as described in the IOM). This course is designed to benefit your organization’s quality professionals responsible for preparing for, facilitating, and responding to FDA inspections; as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.
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:
- Identify key elements of FDA’s Quality System Inspection Technique
- Recognize the types of FDA inspections
- Recognize key activities and responsibilities relative to hosting an FDA inspection
- Identify pre-inspectional databases (e.g. MAUDE, Recall) used by FDA Investigators in preparation for FDA inspections and their utility
- Identify key elements of an effective FDA 483 response
- Prepare (in advance) key documents and information required to be included in an FDA Establishment Inspection Report (EIR)
Who should attend
This course benefits quality professionals responsible for managing, facilitating, and participating in FDA inspections, as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.
This course is important for medical device professionals, especially those who conduct or participate in any project and/or quality management system activity.
Price: $1200.00
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