Effective Investigations and Corrective Actions
(CAPA)
Tools for investigating failures and deviations,
and implementing root cause analyses
On this page...
Benefits of attending for
you and your company
At the end of the course you will... |
| • |
understand what an effective investigation is, and
what it is not |
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be able to implement tools that will allow the company
to rapidly determine the root causes of deviations,
problems and failures |
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implement a sound and effective CAPA program |
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know which tools to use in which situations, and
how to sell management on effective corrective action
and implementation |
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be able to satisfy the regulatory authorities by
performing effective and valid investigations
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| • |
use the tools taught in this course to incorporate
cost-saving methodologies into your company's failure
investigations |
Who Should Attend
This seminar is designed for quality managers, auditors,
production managers and top management interested
in learning the value of good investigations, as well
as how to enhance the QA investigative function as
a valuable cost-savings and quality-improvement tool.
Consultants, auditors and government inspectors will
find this course particularly useful in enhancing
their inspections and capabilities.
Course Langauge
English
Course Overview
When unexpected events happen — you cannot follow
an SOP and need to deviate from it, or you obtain
an out-of-specification test result, or your supplier’s
raw materials marginally fail specification and you
desperately need the material — what do you do?
A few years ago, the standard reaction to an unexpected
event was to ignore it or make an attempt to quickly
fix it. Today, such reactions are unacceptable when
working in a GMP environment. FDA’s strategy
for GMP implementation for the 21st century —
part of its quality systems approach — demand
that proper investigations and corrective actions
take place and be documented. Not only do you need
to investigate the event to determine what happened,
but you need to figure out why the event happened
and resolve it in a manner that prevents recurrence.
It's sound GMP, and makes good business and economic
sense.
A well-managed CAPA (corrective and preventive action)
program not only provides effective and mandated regulatory
compliance, but also yields enhanced productivity.
As part of FDA’s “GMPs for the 21st century” program,
performing effective investigations into deviations
and failures has become a key element of risk management
and GMP improvement, and has become a key focus during
regulatory inspections.
This course teaches tools and techniques that can
be employed to get to the root causes of unexpected
quality events, and help resolve them in a lasting,
GMP compliant manner.
The course will examine actual situations, guiding
participants in effective investigation resolution
and determining solutions to effect proper corrective
action.
Course Outline
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- EU and US GMP requirements for failure investigation
- How the GMP authorities want you to investigate
failures and quality events
- Effective investigations tools:
– Interview skills
– Detective skills
– Documentation skills
- CAPA (corrective action and preventive action
programs): what they are, and what FDA wants from
you
- Being in control: essentials of a CAPA program
- Root causes
– what they are and how to find them
– key considerations in effective analysis
and CAPA analyses
– when pursuit is a waste of time
- Event and causal factors analysis
- FDA’s out-of-specification guidance and US
requirements for effective investigations
- Out-of-specification (OOS), out-of-trend (OOT),
out-of-expectations (OOE) incident investigations
- Documentation of investigations
- Quality event definitions
- Tools for effective investigations:
- Brainstorming
- Ishikawa (Fishbone) analyses
- Pareto analysis
- Force field diagrams
- Six-Sigma analysis
- Kepner-Tregoe® analysis
- Tools for effective fixes:
- Failure mode effect analysis
- Hazard and critical control points
- Fault tree analysis
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| Case Studies |
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– Laboratory out-of-specification incidents
– Manufacturing failures
– Manufacturing deviations |
| Workshop |
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What to do when everything is going wrong —
isolating problems, determining root causes, deciding
on immediate fixes to stay in business |
Previous Participant Testimonials
The seminar has proven to me that
my company was on the right track with the investigation
program implemented a few years ago. There is, however,
room for improvement and your seminar has given me
the tools to make these improvements. Thank you.
Guylaine Raymond
I truly enjoyed the course: you are a great presenter!
This was a great eye-opener on how to actually perform
these activities.
Hugo Tremblay, Merck Frosst Canada
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