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What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by

FDA Warning Letter Form 483 ResponseSo you’ve received an FDA Form 483, but you were prepared. You completed a productive inspection close-out meeting and gained [...] Read More

Root Cause Analysis as a Tool for CAPAs

September 12th, 2014 by

CAPA Root Cause AnalysisCAPAs, or Corrective and Preventive Actions, are largely designed to help GxP-regulated firms handle non-conformity problems. In order to deal with undesirable occurrences in manufacturing processes, [...] Read More

How Can Your Firm Use Quality Risk Management?

July 25th, 2014 by

Quality Risk ManagementRegulatory compliance can be tricky, especially when it comes to your overarching quality management services. There are many guidelines, regulations and laws to understand in order to be compliant in [...] Read More