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Monday, April 9 • 8:00am - 5:00pm
Workshop 7 - CAPA 201: Creation and Effectiveness - (Across GxPs) (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.

An effective CAPA process begins with Root Cause Analysis and ends with CAPA Effectiveness. The process requires strategic direction, risk assessment, effective communication, accountability and responsibility agreed and clearly defined. This course will take a deep dive into the CAPA Process; the purpose, effective CAPA creation and how to use the information for fundamental organization change.

Objectives At the end of the course, the participants shall be able to: 
  • Understand the value of an organization CAPA Process
  • Move from Root Cause identified to corrective and preventative action by:
  • Developing a CAPA that addresses the Root Cause (case studies to be provided for hands-on)
  • Ensure CAPA is valid and validated
  • Effectiveness checking of CAPA via internal audit review
  • Systematically implement global CAPA process

Target Audience
Intermediate to advanced. Must have completed the CAPA Problem Definition - Beyond Human Error class or have a solid understanding of Root Cause Analysis.

  • 8:00 am - 10:00 am
  • Review of Problem Definition and Root Cause Analysis
  • Group Refresher Root Cause Analysis
  • 10:00 am - 10:15 am
  • Break
  • 10:15 am - 12:00 pm
  • The Purpose of a CAPA
  • How to Facilitate CAPA Effectiveness
  • Group Practice (CAPA Steps 5-6)
  • 12:00 pm - 1:00 pm
  • Lunch Break
  • 1:00 pm -3:00 pm
  • Group Practice and Report
  • Fundamental Change through Trend Analysis and Process Improvement
  • 3:00 pm - 3:15 pm
  • Break
  • 3:15 pm - 5:00 pm
  • CAPA Systems
  • Group Scenario - CAPA Systems and Communication
  • Q&A


Bob Figarotta

Associate Director - Clinical Quality, Allergan
Bob Figarotta is an Associate Director – Clinical Compliance, Global Regulatory and Development Quality at Allergan, operating out of the Irvine, California office. His current responsibilities include leading the GCP System Audit program. He has been auditing in the evolving GCP... Read More →
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 →

Monday April 9, 2018 8:00am - 5:00pm PDT
Platinum 4

Attendees (5)