CAPA Training and Causes of Warning Letters due to Lack of Comprehension 2014

Key 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