CAPA/Root Cause Analysis: Achieving Compliance with Proper CAPA Systems

30 Mar 2023
10:00 AM PDT | 01:00 PM EDT
90 Minutes

This webinar will include discussions on 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.

AREA COVERED

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

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

WHO WILL BENEFIT?

  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  • Supplier Quality Personnel & Management

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
  • 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
  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  • Supplier Quality Personnel & Management
Webinar Option
Live + Recorded Session
Live + Transcript
Live + Training CD
Transcript (PDF Transcript of the Training)
Downloadable Recorded Session
Training CD
Group Session Participants + Recorded

Live Session for 10 Participants (For adding extra attendees please contact our Customer Support Team)

Speaker Profile

ins_img Danielle DeLucy

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she …

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