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.
Course tutors can include:
Robert Ruff - Robert Ruff has over 35 years of experience in the medical device and public health sectors, including working in orthopaedic implant manufacturing and completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes leading the development of the Medical Device Single Audit Program as well as co-authoring the MDSAP Audit Approach and the Quality System Inspection Technique (QSIT). Since 2017, Rob has conducted audits relative to a variety of criteria for NSF. He is also responsible for NSF training on medical device manufacturing topics. In this role, Rob has developed courses on a range of subjects, including auditing against the EU MDR and EU IVDR, risk management, FDA inspection readiness, design controls, and more.