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MMD-109 Management Overview on Medical Device Single Audit Program (MDSAP)

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On-Site / Training

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The 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.
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Ampro believes that the key to a successful and rewarding career is continuous professional development.  We have a flexible approach to your training needs with regardless of whatever your requirements, we promise you a high level of service with packages that meet the needs of your business.

As a forward thinking company we deliver training at all levels, thereby supporting your company at every stage of its development. Courses can be delivered onsite at a location of your choice, costs dependent upon location and numbers, or at hotel.

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