Expectations for meaningful, results driven CAPA activities are increasing among regulatory agencies world wide. Almost 60-70 % of warning letters are related to CAPA. EU’s ISO 14971 and the FDA’s QSIT and Q9, underscore this increased emphasis. Growing high-profile field problems indicate that QA / CAPA activities are not yet fully utilizing the power of current risk management tools. The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop CAPA as an integral part of Quality Management Systems planning, implementation and execution.
The essential component of a closed loop CAPA system is how you re organize and distribute the scare resource for those activities which has higher opportunity cost and high value.
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