MDSAP Internal Auditor Training
About This Course
This virtual instructor-led course was designed and developed by the Medical Device Single Audit Program (MDSAP) Lead Project Manager responsible for the team that designed, implemented, and maintained the MDSAP program.
This training focuses internal auditors on the applicable MDSAP country-specific requirements that are applicable to the auditee organization. This focus, when used in conjunction with an existing ISO 13485 internal audit program, will provide the comprehensive coverage necessary to assure all applicable MDSAP regulatory requirements are audited. In addition, resources and insight into how MDSAP Auditing Organizations establish competence of their auditors will be discussed.
An “MDSAP Lite” audit tool will be provided including country-specific requirements and hyperlinks to the specific regulatory requirements (audit criteria) relative to each country-specific requirement. Through expertly designed individual and group tasks and activities, learners will demonstrate how to identify applicable country-specific requirements, how to plan the time necessary to conduct the audit of applicable country-specific requirements, how to plan an MDSAP Lite audit, as well as how to identity, document, and grade country-specific nonconformities.
This training is essential to anyone engaged in planning or conducting internal audits of an organization participating in MDSAP.
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.
Key Learning Objectives
At the end of this training, you will be able to:
- Describe an MDSAP Audit and identify criteria used during an MDSAP Audit
- Recognize International Medical Device Regulators Forum (IMDRF) governing procedures relative to MDSAP Auditing Organizations
- Recognize the competency and training requirements for AO auditors
- Recognize the structure and utility of the “MDSAP Lite” internal audit approach and “Toolkit”
- Calculate audit time and plan an MDSAP Lite internal audit
- Identify nonconformities, write nonconformity (NC) statements, and support the nonconformity statements with audit evidence
- Identify post-audit MDSAP activities including NC grading
- Recognize the outcomes and goals of an MDSAP audit
Who Should Attend
This class is helpful for experienced internal auditors seeking to expand their auditing knowledge to MDSAP.
Cost: $1,200
Tutors
Course tutors can include:
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.
Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices. She has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. She 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 an RABQSA Quality Systems Lead Auditor.
Additional Recommended Courses
CQI & IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements
This virtual instructor-led CQI/IRCA accredited course provides learners with the skills and knowledge that have taken many experienced auditors decades to develop. This course is fundamental to achieving CQI/IRCA Lead Auditor status. During the course, learners will plan, perform, and report audits based on case studies that simulate internal, supplier, and third-party audits utilizing MDSAP audit criteria. Learners will participate in simulated auditing exercises that include planning and performing audit activities, evaluating audit evidence, and documenting audit findings.
The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for non-native English-speaking learners, and learners with disabilities).
Learners should enter the QMS Lead Auditor course with a basic understanding of ISO 13485:2016. Mandatory prerequisite reading and a prerequisite competency assessment will be provided upon enrollment. These prerequisites must be completed in advance of the course start date.
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.
This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.
By the end of this course you should be able to:
· Describe the purpose of:
- Quality management systems
- Quality management system standards
- Management system audits
- Third-party certification
· 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 ISO 13485:2016 and MDSAP participating country-specific requirements.
Price: $2800.00
EU IVDR Internal Auditor Training
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
Medical Device Single Audit Program (MDSAP)
This virtual instructor-led one-day course (delivered over 2 half days) 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