Medical Device CAPA Deviations and Writing Nonconformities
About This Course
This highly interactive CAPA deviations course provides students around the globe the tools and skills needed to conduct root cause investigations using best practices. We guide you through the methodology to identify root causes, restore performance and effectively write corrective action plans.
Key Learning Objectives
At the end of the course, you will be able to:
- Understand the requirements for corrective and preventive actions (CAPA) specific to ISO 13485 and the U.S. Quality System Regulation (can be modified to include EU MDR as well)
- Explain the purpose of CAPA
- Understand the components of CAPA investigations
- Practice CAPA critical thinking
- Understand the link between CAPA and other U.S. Quality System Regulation (21 CFR Part 820) requirements, including risk management
- Write effective nonconformities related to CAPA requirements
- Know where to find guidance and other resources
Who Should Attend
NSF’s CAPA deviation and writing non conformities course is important for medical device professionals, especially those who conduct or participate in root cause investigations.
Course tutors include:
Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.