In this course, we will introduce you to a new method of managing your CAPA system, The Gateway: A Risk-based Filter. 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.
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.
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
Course Provider
Ken Peterson,
