Using Risk Management to Improve Design Controls

FDAnews

Devicemaker Quality Compliance:

Using Risk Management to Improve Design Controls

**An FDAnews Brief**

http://www.fdanews.com/products/54722-devicemaker-quality-compliance    

Devicemakers must establish strict design control procedures as part of their quality management system. And, they must create a risk management system to satisfy the FDA and international regulators.

Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls shows manufacturers where design control and risk management requirements overlap so they can serve both with one integrated effort. Readers will learn:


  •     Which U.S. and international standards address each of the systems
  •     Where FDA regulations differ from European standards
  •     The standard flow of design control procedures
  •     The four phases of risk analysis
  •     How to define the authority and responsibility of people involved in design

Devicemaker Quality Compliance shows how to create a robust quality operation and meet the goals of both the quality management system and risk management system.

Who Will Benefit:

  •     Quality Managers
  •     Design Engineering Managers
  •     Production Managers involved in production and process changes
  •     Quality Engineers
  •     Design Engineers
  •     Manufacturing Engineers
  •     Regulatory Affairs Managers
  •     Risk Management Professionals

FDAnews Brief Details:

Devicemaker Quality Compliance:

Using Risk Management to Improve Design Controls

**An FDAnews Brief**

Price: $177

http://www.fdanews.com/products/54722-devicemaker-quality-compliance

Easy Ways to Order:

Online:     http://www.fdanews.com/products/54722-devicemaker-quality-compliance            

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…

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