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Corrective and Preventive Action CAPA and Audit Training - Skills for Regulated Industry Professionals

Getting the Most Out of Your CAPA and Audit Systems &
Become a Superb Investigator - Training Provided in Various Locations

CAPA is more than just having a good response to solving problems and correcting their respective causes. CAPA is a process that manages how issues are input, processed and funneled into your quality system and requires critical thinking for the successful identification of problem resolution, the implementation of that resolution, and the subsequent verification of the resolution's permanancy. The skills and tools required for successful CAPA management can be mastered and utilized with the help of MasterControl and Pathwise's CAPA training workshops.

Don't miss the upcoming CAPA and Audit Management classes taught by MasterControl and PathWise professionals.

  Corrective and Preventive Action (CAPA) Management
Stringent CAPA policies have caused a host of compliance issues for life science companies this year. In this workshop, you’ll gain hands-on training from MasterControl and PathWise experts who will teach you the practical skills necessary to help shorten and better manage CAPA investigations -and improve product quality and ensure compliance.
Click here for locations, dates, and agenda, and pricing
  Audit Management Training Also Available
Learn how to act in the role of an internal or supplier quality auditor, sharing insight into pertinent regulatory requirements, as well as the necessary planning, performance and post-audit remediation techniques. You’ll discover best practices for audit planning, audit preparation, audit administration, client communications, observation writing and reporting and more.
Click here for locations, dates, agenda, and pricing

In addition to CAPA training, the MasterControl QMS Core Software Forms solution will be presented and utilized to demonstrate how CAPA tools and processes can be thoroughly automated to manage the entire CAPA process. The CAPA training courses will also provide skills and tools to eliminate the following common CAPA problems:

  • Countless open CAPAs with no resolution and too many people involved
  • Internal investigators who can't solve problems and find causes
  • Ineffective processes to utilize with personnel presenting data for root cause analysis
  • CAPA processes that don't pass global FDA and EMEA standards
  • No uniform, solid method for investigating problems
  • No process for verifying and validating corrective actions that work

Course Overview

  • Quality Events - Examine the feeders to your CAPA system and learn to manage complaints, deviations, audit findings, and seven other quality events. Feeders will also be examined and key questions regarding CAPA forms will be discussed.
  • Issue Review - Identify and prioritize events based on risk. Set up risk gateways into electronic solutions
  • Root Cause Analysis - Investigate systemic issues to identify underlying causes
  • Implementation and Effectiveness Checking - Solution selection, verify and validate, implement, monitor and confirm success

The course is taught using a blended approach of classroom and real-life application. This "how-to" approach significantly increases knowledge retention and allows participants to apply the skills as they learn in a dynamic setting.

Skills Learned
Throughout the course, participants improve their ability to:

  • Assess and prioritize each event based on risk and map form-to-form risk filters
  • Gather relevant information through specific, focused questioning
  • Pinpoint root causes using facts instead of guesswork or opinion
  • Integrate intelligence into forms and set up guidance paths that are based on regulations
  • Avoid costly experiments and trial fixes by logically testing possible causes
  • Target potential problems before they happen and develop actions to prevent them
  • Effectively involve others in the investigation process
  • Check effectiveness of corrective/preventive actions
  • Document the analysis in an easy-to-use, logical and defensible format

Who Should Attend?
This course is appropriate for individuals who are regularly called upon to resolve problems or whose input would aid in preventing problems. Examples include investigators, laboratory, QA/RA functions, managers, manufacturing supervisors, technicians, and engineers.

About the Presenters

Ken Peterson
Quality Management Architect
MasterControl, Inc.

Ken Peterson is a Quality Management Architect with a strong background in both life sciences and engineering. He has more than 25 years' experience in consulting and organizational change, quality management and product development. His responsibilities at MasterControl Inc. include enhancing the Quality Management System solution product offering and incorporating best practices for managing CAPA within the MasterControl client solution.

Currently Mr. Peterson is Chairman of the Board of Directors for Intermountain Biomedical Association (IBA) and on the Board of Advisors for the Utah Technology Council (UTC). He works closely with FDA and business to drive growth and build lasting partnerships.

Before joining MasterControl in 2008, Mr. Peterson served as the CEO at PathWise Inc., an education and consulting firm that specializes in compliance and process management. Prior to his 15-year tenure at PathWise, a company which he founded, Mr. Peterson was with Pfizer Corporation, where he obtained a rich understanding of both the pharmaceutical and medical device industries. The areas in which he was involved include customer service, product development, marketing, delivery, quality systems (specifically CAPA and risk management), sales systems, and policy changes. He has successfully solved hundreds of quality problems from high-impact CAPA investigations to installing better quality management systems.

Mr. Peterson graduated from Brigham Young University in Provo Utah in 1981, and was one of the founding members of the College of Entrepreneurship at Brigham Young University. He speaks annually at such organizations as AAMI, PDA, the American Society for Quality, Barnett International, The Executive Committee (TEC), and other industry forums.

Nathan Conover
Senior Partner

Nathan has spent nearly a decade working within the Medical Device and Life Science Industry. His main focus has been around managing world-wide integrations of risk and corrective/preventive action systems, procedures, process, and skills. Nathan has completed global rollouts with many of the Fortune 500 companies in the Life Science Industry. Over the past five years, much of Nathan's time has been spent in the European Life Science Community, working with both life science companies and regulatory investigators. This experience has given him a broad insight into many different markets, cultures, and regulated environments, which help PathWise tackle many of the challenges associated with the globalization of the industry. He regularly presents and consults with large to medium size organizations around the world on how to improve quality and how to stay in compliance with FDA and ISO standards and regulations. He is a faculty member of the Parenteral Drug Association (PDA), Association for the Advancement of Medical Instrumentation (AAMI), and IVT. He earned his Bachelor's degree in Science from the University of Utah, received an MBA from The George Washington University, and is a Certified Leadership Coach. He is currently pursuing a Masters Degree in Biotechnology from Georgetown University.

Need help, have questions? Email Jill Bumgardner at

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