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Effective and Compliant CAPA
Systems
(8 hour course)
Deficiencies in Corrective
and Preventive Action (CAPA) systems continue to trigger
the largest number of FDA 483s and Warning Letters. Why do so many companies
get
it wrong? Perhaps they don't understand that CAPA is so much more
than merely a
tracking mechanism for non-conformances.
FDA wants your CAPA system to use a variety of
mechanisms and information sources
to monitor and improve the quality of people and processes throughout
your product's
lifecycle. Learn more about these CAPA tools, data sources, ands
best practices by
attending this 8-hour, hands-on training class developed by EduQuest.
You’ll
examine:
·
Regulatory
Requirements for CAPA
·
Key elements
of a compliant CAPA system
·
32 important
and often overlooked sources of CAPA data
·
Distinctions
among “corrections”, “corrective actions”, and “preventive actions”
- and why it’s important to know the difference
·
FDA guidance
for failure investigations and root cause analyses
·
How to use
“SOAP” to clean up your CAPA system
·
Trending
requirements – and how Quality Data Trending helps you better manage
risks
·
Lessons
learned from recent FDA 483s and Warning Letters
Course
Objectives:
·
Identify
corrections, corrective actions and preventive actions
·
Learn terms
that are used to describe non-conformities
·
Identify CAPA
data sources
·
Learn elements
of a compliant CAPA system
·
Learn to
assess CAPA tools based on the key points to consider
·
Learn how to
conduct a proper failure investigation to its root cause
·
Used trended
results to find CAPA problems within and across data sources
Course
Agenda:
·
Regulatory
Requirements for CAPA
o
FDA’s
requirements for Corrective and Preventive Action systems
o
Why CAPA systems
continue to be at the top of FDA’s enforcement list
·
Elements of
Effective CAPA Systems
o
Framework for
a compliant CAPA system
o
Definitions of
a correction, corrective action, and preventive action
– and why the difference
matters
·
CAPA Tools
o
CAPA data
sources – gathering feedback from throughout your organization
o
Recommended
flow chart for CAPA data collection and closure
o
Picking the
right CAPA tracking tools
·
What to Look
for in Failure Investigations/Root Cause Analysis
o
How to conduct
a proper failure investigation to its root cause
·
Trending
Requirements and CAPA
o
Drug and
device trending requirements – what and when to trend
o
Use of
statistics to find and fix CAPA problems
About Your Instructor:
Denise Dion is a Senior
Consultant with EduQuest, a global team
of FDA
compliance experts headquartered near Washington, DC. She spent 18 years
of her career with the FDA, where she saved as an Office of Regulatory
Affairs
(ORA) headquarters’ authority on agency-wide inspections and investigations.
She developed many of FDA’s inspection guidance and
training materials,
including serving as the primary editor of the Investigations Operations
Manual
(IOM) and was one of the authors and trainers of the Quality System
Inspection
Technique (QSIT).
Denise is also the author of the EduQuest white paper on “Using FDA’s Own
Playbook to Prepare for Your Next Audit”.
To
Register or Get More Details:
Email Cece Bland, Director of Training
and Information Services,
at Info@EduQuest.net or call +1 (301)
874-6031. Tuition is $990.
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