This webinar will include discussions proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track. Learning Objectives: Discuss what to do when problems occur Outline the requirements of the CAPA process and procedure including building a CAPA file Choose the most appropriate Root Cause Analysis methods for the situation Establishing a CAPA plan: project summary, individual responsibilities and expected completion dates Management and Oversight of the CAPA system and its documentation Areas Covered in the Session : Definition of a CAPA When a CAPA is needed Development of the essential pieces of a robust CAPA plan Root Cause Analysis Methods Discussion of different Root Cause Analysis methods and benefits of each Establishment of the CAPA Plan Project Summary development Responsibilities of individuals involved Establishing Completion Dates Creating meaningful effectiveness checks Management of the CAPA System Maintaining proper documentation of the CAPA plans Ensuring CAPA plans are progressing Proper close out of CAPA plans Who Should Attend: Quality Control Personnel & Management Manufacturing Personnel & Management Senior Management Regulatory Affairs Personnel & Management Quality Assurance Personnel & Management Supplier Quality Personnel & Management


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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
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recor corp