Executive Conference Corporation
The mission of ECC Webinars is to provide the pharmaceutical, biotech, and medical device industries with leading edge and informative webinars led by experts in their fields, fostering a stronger knowledge base in the workforce.
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Webinar
CAPA/Root Cause Analysis: Achieving Compliance with Proper CAPA Systems
- Date: Wednesday October 16, 2024
- Time: 12:00 pm – 1:30 pm (NY Time)
- Instructor(s): Danielle DeLucy
- Webinar ID#: ECC-642
Course Description: 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.
Course Outline:
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
- 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
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people