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Sunday, April 8 • 8:00am - 5:00pm
Workshop 3 - CAPA 101: Problem Definition - Beyond Human Error (1 day)

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RQAP re-registration units: 2 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Fundamental to an effective CAPA program is the practical application of Root Cause Analysis (RCA) and developing an understanding of the root cause(s), contributing cause(s), and possible cause(s) of the issue/problem. Defining the problem - setting boundaries - is integral to enabling an effective RCA. This course will provide tools, insight and best practice to support continuous process improvement and enable sustained results by emphasizing approaches to defining the problem and analyzing the causal factors. A common deficiency in many Industry CAPA programs is a myopic RCA identifying human error and solely prescribing training as the preventive mitigation. By going beyond human error and training, the effective CAPA program becomes a systematic assessment, focusing less on the individual and more on the process(es) in place (What about the process that allowed the issue to occur?) and the process quality control (What about the process that allowed the issue not to be detected?).

At the end of the course, the participants shall be able to: 
  • Understand the difference between reactive and proactive
  • Understand the advantage of a systematic methodology
  • Know what is CAPA?
  • Define a problem (case studies to be provided for hands-on)
  • Understanding high level process mapping
  • Apply root cause analysis, including process tools (fishbone/is-is not/5 Whys)
  • Develop corrective action that addresses the Root Cause

Target Audience

avatar for Eric Humes

Eric Humes

Executive Director, QA, Medpace
Eric Humes is Executive Director, Quality Assurance at Medpace. Medpace is a full-service global contract research organization providing drug, biological and medical device development expertise from test-tube to marketing approval. Mr. Humes has a broad range of industry experience... Read More →
avatar for Donna McElcar

Donna McElcar

Clear CQA
avatar for Judy Zahora

Judy Zahora

Head, Project Management Office, Biogen
Ms. Zahora is Global Lead, Process Documentation Management for R&D at Biogen where she defines and implements R&D GxP documentation standards to ensure compliant, clear, and effective documentation of GxP processes. She has over 30 years’ experience working in IT, Finance, Process... Read More →

Sunday April 8, 2018 8:00am - 5:00pm PDT
Platinum 4

Attendees (5)