Quality is always the result of excellent work without compromise.
MMD-109 Management Overview on Medical Device Single Audit Program (MDSAP)
Schedule and Hours
ThThe Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. Regulatory Authorities participating in the MDSAP include the Australian TGA, Brazil’s ANVISA, Health Canada, Japan’s MHLW & PMDA and the US FDA.
Top together with senior management are seen as core to the strategization, deployment and continued maintenance in complying to regulatory and MDSAP requirements. They hence will be assessed during the audits on their familiarity on these and other compliance matters.
Participants will be led by an experienced trainer whom, in addition to being a CE Marking auditor, technical file reviewer and Quality Systems/ GMP auditor, has 3 decades of assessment, training and quality assurance as well as management system development experience. Participants will be in a position to understand the MDSAP framework as well as their roles when hosting such audits.
Participants will gain a thorough understanding of:
The MDSAP fundamentals
The principles and approach of the MSDAP Program
The process structure and audit tasks.
The approach of an auditing organization
Overview of MDSAP
Structure & scope of the MDSAP audit program
Comparison between MDSAP and other Quality Management System (QMS) audits
The role of management in MDSAP
The management team operating under their company’s QMS and those with executive oversight of:
Device Marketing Authorization and Facility Registration
Measurement, Analysis and Improvement
Adverse Events and Advisory Notices Reporting
Design and Development
Production and Service Controls
Purchasing and Supply Chain
This is a 1-day programme. This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
We are HRD Corp (Human Resource Development Corporation) Registered Training Provider. All of our training modules are claimable under HRD Corp.