FDAnews Announces — Preparing for the MDSAP Audit Process: A Case…


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In less than half a year, devicemakers selling into Canada, Japan, Australia or Brazil will face a new audit process. It’s called the Medical Device Single Audit Program (MDSAP), and Canada will be imposing it on every imported medical device as of Jan. 1, 2019. The three other nations will follow shortly. FDA and ISO device inspections and audits will change too. This country is a member of the five-nation compact that agreed to the new audit protocols.

Here’s a golden opportunity to discover what MDSAP audits will be like — what auditors will be looking for. Mark the calendar for Wednesday, July 11, when consultant Connie Hoy walks devicemakers through this unfamiliar audit territory. Over the course of 90 fast-paced minutes, attendees will discover best practices for:

  • Using the Companion Document to most successfully prepare for the MDSAP audit
  • Quality system: Insuring that it 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!

The clock is ticking on MSDAP audits. Devicemakers have a lot to learn and less than six months to learn it. Start the process with this webinar.

Meet the Presenter:
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.

Who Will Benefit:
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

Webinar Details:
Preparing for the MDSAP Audit Process:
A Case Study from the Manufacturer’s Perspective
**An FDAnews Webinar**
July 11, 2018 — 1:30 p.m. – 3:00 p.m. ET

$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/mdsapauditprocess                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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