The Center for Professional Advancement, Amsterdam
12-13 November 2007
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.
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