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What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by Henry Macartney

So you've received an FDA Form 483, but you were prepared. You completed a. [...] Read More

Posted in Quality Management Systems

Root Cause Analysis as a Tool for CAPAs

September 12th, 2014 by James Francum

CAPAs, or Corrective and Preventive Actions, are largely designed to help. [...] Read More

Posted in Root Cause Analysis

How Can Your Firm Use Quality Risk Management?

July 25th, 2014 by Henry Macartney

Regulatory compliance can be tricky, especially when it comes to your. [...] Read More

Posted in Quality Risk Management

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