CAPA Management - How to Improve the System and Make it Sustainable
OVERVIEW
In
order to solve problems every organization must know how to conduct an
investigation in the workplace, identify root causes, and implement workable
corrective action in a timely manner. An effective CAPA management 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, CAPAcompliance checklist, the new CAPA law, 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.
AREAS
COVERED
•
Definition of a CAPA
o When a CAPA is needed
o Development of the essential pieces of a robust CAPA plan
• 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 procedures
o Ensuring CAPA plans are progressing
o Proper close out of CAPA plans
o When a CAPA is needed
o Development of the essential pieces of a robust CAPA plan
• 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 procedures
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 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 procedure and its documentation
• Outline the requirements of the CAPA 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 procedure 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.
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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