Medical Device Single Audit Program (MDSAP)

2- Day Training for RA/QA Professionals of the MD Industry

Medical Device Single Audit Program (MDSAP)

California | July 15-16, 2020 | Register Now!

About the training

MDSAP-recognized Auditing Organizations (AOs) can conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the program. The participants include Australia (TGA), Brazil (ANVISA), Health Canada (HC), Japan (MHLW and PMDA) and the United States Food and Drug Administration (FDA).

The purpose of this training is to equip medical device manufacturers with the skillset and tools to be to host an MDSAP audit and allow them to determine if their own internal QMS processes are consistent with the requirements of the MDSAP audit mode for the jurisdictions where their products are marketed.

GMED North America has created a 2-day training session, to equip medical device manufacturers with the right understanding and implementation of the Medical Device Single Audit Program (MDSAP).

During this 2- day course, you will learn:

• Techniques to improve auditing skills focused on regulatory auditing
• How to improve competence for MDSAP internal auditors and the support needed to host a MDSAP audit
• Ways to assess your own audit models and suggest improvement
• Ways to be prepared to support an efficient MDSAP audit by your selected Auditing Organization

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Keywords:  European Medical Devices Regulation 2017/745, Quality Management System (QMS) , Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Electrical Safety (IEC 60601-1), Medical Device Electrical Safety, ISO 14971:2007, IEC 62366-1:2015), MDSAP, Medical Device Audit, Medical Device Single Audit Program (MDSAP).

WHO SHOULD ATTEND

• Medical Device Manufacturers: Senior Management, Regulatory Affairs Managers and Quality Managers, R& D specialists, Development, Manufacturing and Marketing Managers,
• Internal and external Auditors
• Importers
• Distributors

REQUIRED LEVEL

• Good knowledge and effective practice of the ISO 13485:2016

The number of participants is maximized to fifteen to provide a stimulating and practical working environment.

EDUCATIONAL RESOURCES

• Presentations
• Practical working sessions
• Course evaluation
• Lunch meeting with the trainer (Lead Auditor and Technical File Assessor for high risk devices)

LEARNING OBJECTIVES

• Understand and Demonstrate awareness of MDSAP fundamentals
• Understand the structure and scope of the MDSAP audit program:
• Understand MDSAP and organizational regulatory compliance
• Understand MDSAP reporting and nonconformity grading
• Explain the differences between MDSAP and other QMS audits
• Understand MDSAP and auditing in the medical device industry
• Be able to identify MDSAP documentation

DAY 1 & 2

8:30 am to 9:00 am – Breakfast

9:00 am – 12:15 pm       

• Concepts and principles introduced by MDSAP
• The scope of the MDSAP audit and how it works
• MDSAP : The benefits for global organization
• MDSAP actors
• The MDSAP report
• MDSAP documents and forms

12:15 pm - 1:00 pm - Lunch

1:00 pm- 5:30 pm           

• The MDSAP Audit Cycle
• MDSAP Audit Model: a process approach
• The Medical Device Manufacturers MDSAP Audit Sequence
• Explanation of the grading of non-conformities for MDSAP
• The transition timelines to MDSAP for ISO 13485 certified companies
• Q&A session

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About the trainer

Anne Le Rouzo  Lead Auditor and Technical Documentation Assessor Anne is Certified Senior Lead Auditor and Technical Documentation Assessor for GMED North America. She joined GMED NA in 2005, reviewing Class III devices Technical Documentation, and performing onsite audits for CE marking and Quality Management System certification according to ISO13485 and MDSAP. As a Technical Documentation Assessor and Lead Auditor, Anne’ expertise focuses on high-risk medical devices, including but not limited to Orthopedic, Cardiovascular, and Neurovascular technologies. Prior to joining GMED NA, Anne worked extensively in the Orthopedic Industry as Director of Regulatory Affairs and Quality Assurance, participating in the implementation of Design and Development processes for new joint implants (shoulder, knee, hip, elbow, and ankles) as well as the validation of Production processes. Anne is also an active member of the French Standards Organization, AFNOR, participating in the elaboration of new standards whose application impact orthopedic implants.