Course offering number:1207-301
Course ID:
2089
Root Cause Investigation for CAPA
July 17-18, 2012
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
• R&D
• Quality Assurance
• Maintenance
• Manufacturing
• Distribution
• Product/Process Development
• Engineering
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
In this exciting and team-based seminar you will be challenged
to apply the methodology and tools on real case studies.
This will prepare you to confidently conduct successful
investigations immediately upon returning to work.