FDAnews Announces — New Management Report — Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

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This report, Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers, lays out the basics of building a four-phase qualification plan including design qualification, installation qualification, operational qualification and performance qualification that satisfies US and EU requirements.

Principles of Equipment Qualification:
A Guide for Drug and Device Manufacturers
**An FDAnews Management Report**
http://www.fdanews.com/products/54648-principles-of-equipment-qualification    

The FDA and EMA stress the importance of equipment qualification.

Manufacturers must prove that their equipment, operations and processes all work the way they’re supposed to? If not, they can’t reliably produce a quality product and pass regulatory muster.

This report authored by international GMP expert Thomas Peither and associates lays out the basics of building a four-phase qualification plan including design qualification, installation qualification, operational qualification and performance qualification that satisfies US and EU requirements. Readers will learn:

  • How the four phases of qualification differ and how they work together
  • EU requirements for qualification
  • How to document qualification activities
  • How to document qualification in a validation master plan
  • How to apply risk analysis methods to qualification
  • Roles and responsibilities of qualification team members

Who Will Benefit:

  • Quality assurance/control
  • Engineering staff
  • Equipment managers
  • Production head
  • Systems designers

FDAnews Management Report Details:
Principles of Equipment Qualification:
A Guide for Drug and Device Manufacturers
Price: $397
http://www.fdanews.com/products/54648-principles-of-equipment-qualification    

Easy Ways to Order:
Online:     http://www.fdanews.com/products/54648-principles-of-equipment-qualification            
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
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