Preparing for a MDSAP Audit – Webinar Recording/Transcript
Preparing for a MDSAP Audit: A Case Study from the Manufacturer’s Perspective
Devicemakers that export into Canada, Japan, Australia and Brazil face important changes to the audit and inspection process as the new Medical Device Single Audit Program (MSDAP) goes into effect.
Canada imposed the new requirements on Jan. 1.
The changes differ in important ways from what you’re used to. Now is the time to get a drop on them.
Consultant Connie Hoy takes you through the changes — what’s the same, what’s different, how you’ll have to alter your thinking.
- Using the Companion Document to most successfully prepare for the MDSAP audit
- Quality system to insure that yours completely covers specific country requirements
- Registration review details: Specifics to expect in this portion of the audit
- Differences in emphasis: Unfamiliar questions the MDSAP auditor is likely to ask
- Audit procedures: How the MDSAP audit is conducted and how it differs from FDA inspections and ISO audits
- Grading system for nonconforming: What it means
MSDAP is here — don’t get caught short. Start figuring things out now with this presentation.