Proper CAPA Management and Root Cause Analysis

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Jul 14, 2016
60 minutes
Product Description

Effective Problem Solving With Proper CAPA Management and Root Cause Analysis

In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily.

In this session expert speaker Danielle DeLucy will provide insights on proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan. You will also get tips on how to develop CAPAs pertaining to long-term projects and ensure they stay on track.

Session Highlights:

  • 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 should attend?

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

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

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...   More Info
More Events By The Speaker

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