Conducting Supplier Audits: A Guide for Medical Device Manufacturers

$377.00
September 2009
978-1-60004-083-2
43
Also Available:

Medical device manufacturers — the supply chain buck stops with you. You are responsible for quality and safety of your products. And the FDA isn’t letting you forget it. Last year, more than half of warning letters for quality system violations focused on supplier-quality issues.

A proper audit catches problems early. But do your audits spot what FDA investigators will look for — identification and traceability for components, notifications and approvals of changes, compliance with quality system requirements, proper training of employees, and lots more besides?

If you answered no ... or even maybe ... then this special report could be a godsend. Announcing the publication of:

Conducting Supplier Audits:
A Guide for Medical Device Manufacturers

This all-new guide from FDAnews walks you through the steps of managing supplier audits, from initial contract negotiations ... to risk assessment ... to actual conduct of audits ... to documenting and preparing for FDA inspection. In simple English, Conducting Supplier Audits lays out a clear path to:

  • Elements of a risk-based supplier quality program that will satisfy the FDA
  • Methods for assessing suppliers based on risk
  • Which audits and documentation manufacturers must require of suppliers
  • Drafting supplier contracts that include adequate audit requirements
  • Creating adequate change control procedures
  • Manufacturers’ regulatory responsibilities in regard to suppliers
  • How to determine whether you need onsite monitors at supplier locations
  • And much more!

Buy Now!
This first edition of Conducting Supplier Audits: A Guide for Medical Device Manufacturers is expected to sell out quickly. Future editions and updates may be priced higher. That’s why it’s a good idea to order your copy today. Conducting Supplier Audits: A Guide for Medical Device Manufacturers is available for $377 in print and PDF format.

Device, diagnostics and contract manufacturers — all will benefit from this report. Make sure to order a copy for everyone in your organization with responsibilities involving:

  • Quality
  • Compliance
  • Regulatory Affairs
  • Legal
  • Consultants

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