Date: 29 May 2018
Duration: 1 Day
Location: Amsterdam, the Netherlands
Subscription: On request (firstname.lastname@example.org)
The Medical Device Single Audit Plan is beyond the pilot program phase and is starting up to replace the normal audit structure. Countries which embrace MDSAP are Australia, Brazil, Canada, Japan and the United States of America. Canada has already announced that as of January 1st, 2019 only audit results according to MDSAP are accepted for regulatory compliance and submissions. It can be expected that other associated Regulatory Authorities will do the same in due time. Audit Organisations also start preparing and implementing the Medical Device Single Audit Plan. So you should do the same.
During the course, you will obtain the knowledge to understand MDSAP and the possible impact on your organization. What are the fundamentals of MDSAP, how are audits performed and what do you need to do to prepare your own organization.
- Being able to explain the MDSAP fundamentals
- Understand the principles and approach of the MDSAP program
- Understand the process structure and audit tasks
- Understand contents and use of the MDSAP documentation
- Awareness of MDSAP requirement structure and contents
- Understand the approach of an auditing organization
- Understand the non-conformity grading
- Being able to analyze and define the impact of the MDSAP program on your own organization/certification program
- What is MDSAP
- How does MDSAP work
- What are the MDSAP requirements
- Does your organization fulfills the requirements
- What do I need to do to facilitate an MDSAP audit
- Q & A
Who should attend:
This training is meant for management, QA and RA managers, internal audit coordinators, internal auditors and others involved in internal and external audits.
A specific entry level is not required. The requirements are based on ISO 13485, so a basic understanding and knowledge of the standard are beneficial.