Medical Device Single Audit Programme (MDSAP) Fundamentals and Readiness
This course will prepare you to host a MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of the MDSAP audit mode for the jurisdictions where your products are marketed.
Who should attend?
- Quality Assurance and RegulatoryAffairs professionals within medical device organizations currently active in participating territories andorganizations expanding their market reach to jurisdictions participating in MDSA
How will I benefit?
- Improve auditing skills focused on regulatory auditing
- Improve competence for MDSAP internal auditors and the supportneeded to host a MDSAP audit
- Assess your own audit models andsuggest improvement
- Be prepared to support an efficient MDSAP audit by your selected AuditingOrganization
- Receive a globally recognized certificate
What will I learn?
- Demonstrate awareness of MDSAP fundamentals
- Explain the structure and scope of the MDSAP audit program
- Explain the differences between MDSAPand other QMS audits
- Prepare to host a successful MDSAP audit.