Effective CAPA Management: How to Implement a Risk-based Approach to Improve Your Quality System

Over the past decade, the FDA has been stressing a risk-based approach in managing your quality system. In effect, many organizations in the Life Science industry are suffering from “Death by CAPA,” using a funnel-based approach to prioritization. Under this system, some non-conformances will be higher or lower in priority based on risk but eventually everything will become a CAPA. This industry practice makes it difficult for QA professionals to manage their system and has not had favorable results. In this course, we will introduce you to a new method of managing your CAPA system, The Gateway: A Risk-based Filter.” This approach handles quality issues based on risk to the end-user, and effectively teaches you to determine which nonconformance’s should become a CAPA and which issues should remain in their respective areas of the quality system.

Areas Covered in the seminar:

• Assessment of Current CAPA Process.
• Introduction to The Gateway: A Risk-Based Filter.
• Identify Risks to the Quality System.
• Identify and Prioritize Key CAPAs.

Who Will Benefit:

This webinar is geared toward professionals in the QA/AC and CAPA discipline and is appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems.

• Engineers
• Investigators
• Laboratory QA
• Manufacturing Supervisors
• Technicians

Instructor Profile:

Ken Peterson,, founder of PathWise Inc., has more than twenty years in consulting and organizational change, management, and development. Formally with Pfizer Corporation, he has a rich understanding of both pharmaceutical and medical device businesses. Areas of project excellence include customer service, product development, marketing, delivery, quality systems, sales systems, and policy changes. He is also one of the founding members of the College of Entrepreneurship at Brigham Young University in Provo, Utah. Mr. Peterson consults routinely on Quality Systems, Problem Solving, and Risk Management. He speaks annually at such organizations as AAMI, PDA, the American Society for Quality Control, Barnett International, The Executive Committee (TEC), and other industry forums. His abilities extend beyond consultation to often teaching the first few critical training programs. Mr. Peterson maintains a detailed approach to measurement and documentation and has a strong background in both human science and engineering. Applying what is learned quickly to real work issues is the emphasis to satisfying our rapidly growing clientele. Mr. Peterson graduated from Brigham Young University in 1981.

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