Trans

Managing CAPA Systems

$349.00
August 2005
1-932074-52-X
157
View
Also Available:

This management report from FDAnews shows you how to establish and maintain an effective CAPA system so you can pass your next inspection. In an easy-to-read format you’ll find guidance critical to avoiding FDA enforcement action, including:

  • Key cGMP requirements for drug, device and biologic manufacturers, and why solid CAPA systems are important to meeting them
  • Top CAPA violations cited by the FDA in 2004
  • Trends in FDA enforcement action related to CAPA
  • CAPA dos and don’ts
  • Tips on maintaining an effective system
  • Standard operating procedures to employ during the investigation of problems
  • Best sources and analysis of data to use in a CAPA investigation
  • A list of frequently asked questions and answers related to CAPA systems

Plus you'll get these time-saving resources —

  • Definitions of CAPA-related terminology
  • The FDA’s drug manufacturing compliance manual
  • The FDA’s guide to inspections of quality systems
Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.

3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.

Interested in Electronic Multi-user Access?
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable.

For more information please contact Customer Service:
Phone:  +1 (703) 538-7600 or toll free (888) 838-5578
Email:  customerservice@fdanews.com