Overview“Proper” completion of the required forms in the “proper” order as described in the corporate directives and site procedures is what is required to remediate and prevent future observations by auditors and inspectors who have found numerous implementation issues and execution as result of variances in overall comprehension (failure to establish and maintain an adequate CAPA program).  Examples are presented during the webinar.Why Should You AttendA 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 approval process.Areas Covered In This Webinar“PROPER”Too often regulatory documents are written using subjective terminology and grammar (first person, pronouns and adverbs) instead of objective, technical descriptions of the element being addressed (stick to the facts).  Lack of technical writing skills has contributed to the majority of the current submission rejections, 483s, warning letters and consent decrees - see FDA examples at end of presentation. "CAPA"Implementing an effective corrective actions or preventive action capable of meeting QS Regulations and satisfying quality assurance and GMP/GDP documentation requirements is accomplished in nine basic steps. 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. Need to understand the difference between correction and corrective action. Learning ObjectivesIdentification of the incident - Criticality of the Incident Tracking System separate from deviation tracking.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 expectationsRoot Cause Analysis training by avoiding subjective thinking to generate objective documentationAction Plan generation listing the tasks, metric applications and acceptance criteria for each activityImplementation Plan example needed to accomplish the Corrective or Preventive Action PlanVerification using stand-alone documentation practices of for objective evidence to meet cGMP regulationsEffectiveness monitoring plan to demonstrate the corrective action and/or preventive action is performing as anticipated preventing reoccurrence or initial occurrence of the identified issue.  Who Will BenefitAuditorsInspectorsRegulatory PersonnelQuality and Documentation PersonnelOperations and Development PersonnelLevelIntermediate