A major consequence of the Barr Ruling in 1993 was the significantly greater emphasis FDA inspections placed on the management and performance of quality control laboratories particularly the handling of Out of Specification results.

As a result of the increased and on-going scrutiny of analytical performance it is hardly surprising that even today the most frequently cited cGMP non-compliances are still found in laboratories, particularly:

• General cGMP understanding and particularly relating to compliance with written procedures
• Validation, performance and transfer of analytical procedures
• Data integrity
• Management of out of specification and suspect test results
• Instrument qualification including an explanation of the new version of USP <1058>and calibration
• Computer validation (including the requirements and actual interpretation of 21 CFR Part 11)
• Operator training
• Management of reagents and standards

This three day course delivered via lectures and workshops will address all these issues.