FDAnews Announces The MDSAP in 2022: Policies, Procedures and Developments Management Report

MDSAP audits can save time, effort and money -- if one knows how to handle them. Here is everything one needs to do just that.

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FDAnews

Feb 08, 2022, 18:00 ET

FALLS CHURCH, Va., Feb. 8, 2022 /PRNewswire-PRWeb/ -- The MDSAP in 2022:
Policies, Procedures and Developments
https://www.fdanews.com/products/62047

Using the medical device single audit program (MDSAP) is shrewd: it allows one to go through one audit to do business with several different countries.

But with recent changes, one needs up-to-date intelligence to help make the most of company resources and to pass audits. You need The MDSAP in 2022: Policies, Procedures and Developments.

MDSAP has been far from static. In the past three years alone, a multitude of procedures have been refined and several new countries have joined — with more on the way. This report provides a comprehensive view of the current state of MDSAP.

The MDSAP in 2022 details the program's principles and procedures, nations that participate in the program and those considering joining, policy developments in individual countries, guidance from the FDA and more.

And it provides readers with strategies for success, showing the specifics of how MDSAP audits work, how to prepare for them, which regulators require them — and which may be about to make them mandatory — and the benefits of voluntary participation.

Management report takeaways:

  • What has changed in the past three years: which countries are participating in MDSAP and which of those require an MDSAP audit
  • How MDSAP audits can be conducted remotely
  • The different types of audits involved, such as initial certification, surveillance, desk and onsite audits
  • The standard schedule for and duration of audits
  • Specific areas auditors will examine and questions they will ask
  • How to use the MDSAP companion document to create an audit preparation checklist that matches the auditors' process
  • The MDSAP grading system and how nonconformance issues can be escalated — and the consequences of getting a bad grade
  • Costs of an MDSAP audit

Bonus: Includes copies of the MDSAP manual and its companion document for step-by-step instructions, guidance from the FDA on remote MDSAP audits, a guide to the program's nonconformity grading scale and other valuable resources.

Save time, effort and money by using MDSAP. Maximize success with The MDSAP in 2022: Policies, Procedures and Developments.

Management Report Details:
The MDSAP in 2022:
Policies, Procedures and Developments
https://www.fdanews.com/products/62047

Price:
$297

Easy Ways to Order:
Online: https://www.fdanews.com/products/62047
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

Media Contact

Michelle Butler, FDAnews, 703.538.7600, [email protected]

SOURCE FDAnews