FDAnews Announces — Preparing for a MDSAP Audit: A Case Study from the Manufacturer’s Perspective Webinar, August 27, 2019

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MDSAP took effect Jan. 1 with Canada and one must obtain certification to continue marketing. More countries to follow…

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Preparing for a MDSAP Audit
A Case Study from the Manufacturer’s Perspective
An FDAnews Webinar
Tuesday, Aug. 27, 2018
1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/preparingforamdsapauditcase

Devicemakers selling into Canada, Japan, Australia or Brazil, listen up: There is a new audit regime.

It’s called the Medical Device Single Audit Program (MDSAP), and Canada began 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. The U.S. is a member of the five-nation compact that agreed to the new audit protocols.

Mark the calendar for Tuesday, Aug. 27, when consultant Connie Hoy walks attendees 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 to insure that an organization 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

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.

Webinar Details:
Preparing for a MDSAP Audit
A Case Study from the Manufacturer’s Perspective
An FDAnews Webinar
Tuesday, Aug. 27, 2018
1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/preparingforamdsapauditcase

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/preparingforamdsapauditcase
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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Michelle Butler
FDAnews
703-538-7600
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