MMD-109 Management Overview on Medical Device Single Audit Program
(MDSAP)
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.
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.
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.
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We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
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