Repeat CAPA investigations are arguably one of the largest areas of concern for Life Science organizations today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as up to 30% of all open investigations- or 1 in every 3.

What percentage of your quality system investigations are repeats?

Vote at http://www.surveymonkey.com/s/89X2LM3

In 2008, the International Organization of Standardization issued a new standard to which all medical device manufacturers should comply. Yet many organizations are struggling to keep up with ISO 9001 2000. What, in your experience, are the critical areas that organizations need to address in order to comply with the new standard?

This week, the FDA introduced FDA Basics, a web resource intended to answer questions from consumers and patients as well as to discuss other important public health topics in a useful and user-friendly format.

Structurally, FDA Basics consists of the following sections:

• FDA Fundamentals
• Animal & Veterinary
• Cosmetics & Color Additives
• Dietary Supplements
• Drugs
• Food
• Medical Devices
• Radiation-Emitting Products
• Tobacco Products
• Vaccines, Blood, and Biologics

Visit http://www.fda.gov/AboutFDA/Basics/default.htm for more info.