CAPA Training and Causes of Warning Letters due to Lack of Comprehension 2017

  • 01 Feb 2017
  • Webinar

Description

Topics
  • Evaluation of the impact or magnitude of the incident
  • Identification of the incident
  • Investigation procedure to assess various strategies in accordance with current regulatory expectations
  • Initiation and Risk Assessment to demonstrate compliance with Quality Systems Regulations
  • Action Plan generation listing the tasks, metric applications and acceptance criteria for each activity
  • Root Cause Analysis avoiding subjective thinking to generate objective documentation
  • Verification using stand alone documentation practices of for objective evidence to meet cGMP regulations
  • Implementation Plan needed to accomplish the Corrective or Preventive Action Plan
  • 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
Who should Attend

Senior-level professionals responsible of:

  • Documentation Personnel
  • Quality

Past Events

Important

Please, check "CAPA Training and Causes of Warning Letters due to Lack of Comprehension" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Internal Audit & Compliance, Operations, Quality assurance

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