The US FDA publishes a set of guidelines, Quality Systems Inspection Techniques. QSIT identifies relevant quality systems within a manufacturing facility, explains how the systems will be audited, and offers advice on how to make your systems conform to QSIT guidelines. Systems that pass audit without violations are less likely to be audited in the future. PharmaNet Consulting professionals, including former senior-level FDA officials, offer the experience and expertise to assist you in conforming to QSIT guidelines.
PharmaNet professionals available for consultation on this topic include:
Senior Director, Quality Assurance, Anapharm
Vice President, Corporate Quality Assurance and Compliance
504 Carnegie Center, Princeton, NJ 08540