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Corrective and Preventive Action (CAPA), is a “well-known pharmaceutical concept” according to FDA’s quality systems guidance (2006). Actually the concept, while well-known in the medical device industry and through ISO certification systems, has been notably missed in pharmaceutical GMPs to-date. The recently issued ICH Q10 guidance, addresses four specific pharmaceutical quality system elements that augment GMPs to...המשך קריאה
VP Operations, Production Managers, Quality Unit Directors, VP Quality, VP QA / RA, Quality Unit Supervisors, RA personnel, personnel involved in product development, Operations and Production personnel and Supervisors, Laboratory personnel and any other person involved directly or indirectly in compliance and quality related activities.
הנושאים שמעניינים אותי
(אפשר לבחור מספר נושאים)