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Root Cause Investigation for CAPA

 
  November 01, 2010  
     
 
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
1-2 March 2011


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.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Tom Weaver; Quality and Operations Improvement Consultant

Mr. Tom Weaver is a quality and operations improvement consultant whose expertise includes strategic planning, quality and operations improvement, root cause investigation, design control, and project management. Prior to starting his own consulting business, Mr. Weaver had a 28 year career with Baxter Healthcare with management positions in the Manufacturing, R&D, and Quality functions. He retired in 2003 as the Vice President, Quality Management, leading Baxter’s Total Quality Management and Six Sigma processes. In 2003, he founded Weaver Consulting which provides services to clients globally. Mr. Weaver holds a Bachelor of Science Degree from the United States Military Academy at West Point, N.Y.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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