Preparing for the MDSAP Audit Process - Webinar Recording/Transcript

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Preparing for the MDSAP Audit Process: 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.

The deadline is looming: Canada imposes the new requirements next 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.

In 90 lightning minutes, she’ll touch on such key factors as:

  • Using the Companion Document to most successfully prepare for the MDSAP audit
  • Quality system: Insuring 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 really means
  • And much more!

MSDAP audits will be a reality before you know it — less than 6 months. Don’t get caught short. Start figuring things out now with this presentation.

Devicemakers that export to Canada, Japan, Australia and Brazil will benefit from this presentation in general, as will exporters of high-risk devices; and exporters of combination products to Australia will benefit specifically. Job titles include but are not limited to:

  • Regulatory/compliance
  • Quality assurance
  • Manufacturing/GMP/cGMP
  • Supply chain executives
  • Auditors
  • Legal counsel

Connie Hoy of Hoy & Associates Regulatory Consulting is a former EVP of Regulatory, Quality and Clinical Development at Cynosure, a division of Hologic, with three decades of experience in the medical device industry.