MDSAP Internal Auditor Training

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.

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

This class is helpful for experienced internal auditors seeking to expand their auditing knowledge to MDSAP.

Cost: $1,200

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.