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Regulatory Compliance Training > GMP, GAMP® & Validation Training  >  CAPA Training

CAPA Training

Global regulatory agencies such as the USA’s FDA, EU regulators and UK’s MHRA are all targeting Corrective and Preventive Action Systems (CAPA) during routine cGMP inspections, to determine a healthcare manufacturer’s ability to supply products that are consistently fit for purpose.

Common citations from the global regulators in the last year include the following:

'No root cause analysis and CAPA on significant numbers of deviations in errors in packaging record and label generation.'

'No logical process in deviation reporting in OOS results.'

'Your firm did not initiate an investigation to address the root cause of the XXXX 300mg tablets and BBBB 0.75 mg Tablets, when lots 940, 951, 952 and 953 failed AQL sampling tests for overweight tablets.'

'Your firm failed to follow your Corrective & Preventive Action Procedure, ABC/Ver.2, by not adequately determining the root cause of the problem and providing an effective solution that would eliminate the non-conformance or deficiency (corrective action).'

  • ITS’ Understanding Corrective and Preventive Action Systems (CAPA) Training Course provides an understanding of how to run effective Corrective and Preventive Action (CAPA) systems that will benefit the business and satisfy the regulators. The course covers areas that can cause confusion including terms, definitions, deviations, discrepancies, non-conformances and use of corrections, corrective and preventive actions. Course activities include applying the CAPA system and root cause analysis to a potential real case scenario.

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