FDA Documents, Statements Prioritize the ‘P’ in CAPA: Expert
An effective corrective and preventive action (CAPA) program will prioritize prevention and continuity in process improvement — primarily by linking to manufacturing systems beyond those concerned with deviation management and failure investigations, compliance experts say.
Quality personnel at drug companies often express confusion about how an effective CAPA program should be designed, citing the lack of a singular go-to guidance document or manual.
As a result, CAPA issues are routinely cited in warning letters year after year.
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The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
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