Why Should You Attend:
You should attend this webinar to understand, what how is MDSAP working in relation to your internal audit program and how to adjust your internal audit program and finally how to conduct an internal audit according MDSAP requirements.
This webinar will give you a clear structured overview and introduction, how to apply MDSAP-Requirements in your internal audit program and to conduct internal audits with MDSAP requirements. First you learn to identify the relevant requirements, second you learn how to implement the identified requirements into your audit program. The course based on the MDSAP Companion-Document, issued by the FDA.
Agenda
- What is the Medical Device Single Audit Program (MDSAP)?
- Which Companies must have MDSAP?
- Which Companies should have MDSAP?
- How to setup and audit program under MDSAP?
- How to conduct an audit under MDSAP?
- How the MDSAP-Audit is working?
Who Should Attend
- CEO’s of companies, which sell to Australia, Brazil, Canada, Japan or US
- Regulatory Affairs Managers of Companies, which sell to Australia, Brazil, Canada, Japan or US
- Quality Managers of Companies, which sell to to Australia, Brazil, Canada, Japan or US
- Quality Representatives of Companies, which sell to Australia, Brazil, Canada, Japan or US
- Other managers, which need to deal with regulatory or quality guidelines
- Medical Device Manufacturers, who develop, manufacture and/or sell to US, CAN, BR, AUS, JP
