Developing an Effective CAPA Management and Root Cause Analysis System

Duration: 90 Minutes
This 90-minute 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.
CAPA Management and Root Cause Analysis
Instructor: Danielle DeLucy
Product ID: 504754
Objectives of the Presentation
  • 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
Why Should you Attend
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.

Areas Covered
  • 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
Who will Benefit
This training is intended for professionals in the Pharmaceutical and other related life science industries. It will be especially valuable for the following:
  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  • Supplier Quality Personnel & Management
  • Product/Process Development Staff
$299
Recorded Session for one participant
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  $379.00 Training CD
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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 has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
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