Overview: CAPA Implementing an effective corrective or preventive action capable of meeting QS Regulations and satisfying quality assurance and GMP/GDP documentation requirements is accomplished in nine basic steps: Identification of the incident.Evaluation of the impact or magnitude of the incidentInitiation and Risk Assessment to demonstrate compliance with Quality Systems RegulationsInvestigation procedure to assess various strategies in accordance with current regulatory expectations.Root Cause Analysis avoiding subjective thinking to generate objective documentationAction Plan generation listing the tasks, metric applications and acceptance criteria for each activityImplementation Plan needed to accomplish the Corrective or Preventive Action PlanVerification using stand alone documentation practices of for objective evidence to meet cGMP regulations.Effectiveness monitoring plan to demonstrate the corrective action and/or preventive action is performing as anticipated preventing reoccurrence or initial occurrence of the identified issue.The order of the listed activities is critical and all too often not followed in the specified sequence which has a negative effect when CAPA systems are inspected Why Should You Attend: A vast majority of the current industry deficiencies which have led to isolated 483s, Warning Letters and Consent Decrees are the result of deficient technical documentation and effective means of assessing various elements of CAPA expectations for products produced and distributed under the FDA regulations.Price: $225.00GlobalCompliancePanelUSA Phone:800-447-9407Fax: 302-288-6884