Course offering number:0810-202
Course ID:
2089
Root Cause Investigation for CAPA
October 6-7, 2008
New Brunswick, NJ
Who Should Attend
This is a highly practical and workshop-oriented course for
those in the pharmaceutical or medical device industry who
conduct Corrective and Preventive Action (CAPA)
investigations, especially those in the following areas:-
Regulatory Affairs
- Quality Assurance
- Manufacturing
- Product/Process Development
- R&D
- Maintenance
Description
Most organizations have procedures for implementing
corrective and preventive actions, but many do not have an
effective methodology to actually investigate to find the root
cause. As a result the investigation is often careless,
unsuccessful and costly. Root Cause Investigation for CAPA
is a proven methodology to investigate and identify the root
cause when there has been a shift in the performance of a
product, machine, equipment, work process or system.
The methodology identifies the change (or changes) that
has occurred so that the change can be eliminated and the
performance can return to its previous level. It is ideal for
investigating an increase in:-
Product or service defect levels
- Customer complaints
- Negative patient reactions with the product
- Manufacturing scrap or rework
- Equipment or process aberrations
- Any performance change where a CAPA investigation is required
This workshop, intensive course is designed to develop
the skills necessary so that you can conduct an effective
investigation immediately upon returning to your job.