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Developing an Effective CAPA Management and Root Cause Analysis System (MFG762P)

Presented by: Danielle DeLucy, MS
(*) Single User Price. For multiple users please call 1-844-384-4744
Pre Recorded Webinar
60 minutes
Event Description
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Prepare a Robust CAPA Plan For Your Manufacturing System

For every organization, it is crucial to know how to identify the root cause of the issues faced by them, conduct an effective investigation and implement practical corrective actions in a proper and timely manner to resolve those problems.  You will require an effective CAPA process under which there should be training for internal investigators, who can also guide others in the organization to employ critical thinking. The process must have a common language and model within the organization, which will enable the investigators to master the process easily and quickly.

Join this session where expert speaker Danielle DeLucy will give you in-depth details on developing a robust CAPA plan, proper CAPA system maintenance, documentation of the Corrective and Preventive Actions and root cause analysis. You will be provided tips on ways to develop CAPAs concerning long-term projects and how to ensure them to stay on track.

Session Highlights:
  • CAPA Definition
    • When is a CAPA required
    • Developing crucial pieces of a strong CAPA plan
  • Root Cause Analysis Methods
    • Discussing various Root Cause Analysis methods and their benefits
  • Establishment a CAPA Plan
    • Project Summary development
    • Individual responsibilities involved
    • Finalizing Completion Dates
    • Creating meaningful effectiveness checks
  • Managing the CAPA System
    • Maintaining proper documentation of the CAPA plans
    • Ensuring CAPA plans are progressing
    • Proper close out of CAPA plans
Learning Objectives:
  • Analyze what steps to take when there is an issue
  • Know what are the requirements of the CAPA process and procedures and how to build a CAPA file
  • Find an appropriate Root Cause Analysis methods for the scenario
  • How to establish a CAPA plan – expected deadlines, project summary and individual responsibilities
  • Oversight and management 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
About Our Speaker(s)

Danielle DeLucy | Quality Management Compliance SpeakerDanielle DeLucy MS
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 R... More info

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    Event Title: Developing an Effective CAPA Management and Root Cause Analysis System
    Presenter(s): Danielle DeLucy, MS

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