Developing an Effective CAPA Management and Root Cause Analysis System for More Robust Deviations
OVERVIEW
In order to solve problems every organization
must know how to conduct an effective investigation, perform root cause
analysis, 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.
WHY
SHOULD YOU ATTEND
This webinar will include discussions on
proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing CAPA system. It will give
tips on how to develop CAPAs pertaining to longer term projects and ensure they
stay on track.
AREAS
COVERED
• Definition of a CAPA
o When a CAPA is needed
o CAPA basics
o Development of the essential pieces of a robust CAPA plan
o CAPA best practices
• Root Cause Analysis methods
o Discussion of different Root Cause Analysis methods and benefits of each
• Establishment of the CAPA plan
o Project Summary development
o Responsibilities of individuals involved
o Establishing completion dates
o Creating meaningful effectiveness checks
• Management of the CAPA system
o Maintaining proper documentation of the CAPA plans
o Ensuring CAPA plans are progressing
o Proper close out of CAPA plans
o When a CAPA is needed
o CAPA basics
o Development of the essential pieces of a robust CAPA plan
o CAPA best practices
• Root Cause Analysis methods
o Discussion of different Root Cause Analysis methods and benefits of each
• Establishment of the CAPA plan
o Project Summary development
o Responsibilities of individuals involved
o Establishing completion dates
o Creating meaningful effectiveness checks
• Management of the CAPA system
o Maintaining proper documentation of the CAPA plans
o Ensuring CAPA plans are progressing
o 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 management system and its documentation
• 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 management 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
• Manufacturing Personnel & Management
• Senior Management
• Regulatory Affairs Personnel & Management
• Quality Assurance Personnel & Management
• Supplier Quality Personnel & Management
SPEAKER
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.
Use
Promo Code SPRS20
and get flat 20% discount on all purchases.
To Register (or) for more
details please click on this below link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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