An intensive one-day training course on how to establish and improve compliance with the GMP requirements for CAPA, and improving root cause analysis methodology.
Background
FDA statistics have shown that in 82% of inspections of medical device manufacturers, which result in the issuance of a Form 483, deficiencies in meeting the requirements for CAPA as contained in 21 CFR Part 820, §820.100 were observed.
The agency is particularly critical of poor root cause analysis and the subsequent lack of proper verification or validation of the effectiveness of corrective actions implemented. Such situations can become highly problematical for some companies resulting in the issuance of Warning Letters, and in some cases import alerts.
The same concerns are also being increasing raised by Notified Bodies assessing compliance of quality systems with ISO 13485 requirements.
Learning Objectives
This course is designed to show how compliance with the requirements for CAPA can be improved. It also provides information on what makes people poor problem solvers and what simple but effective techniques can be deployed to improve root cause analysis. The course provides an excellent opportunity to understand:
- The regulatory requirements relating to CAPA and RCA, and business benefits.
- The key steps in performing adequate problem definition and root cause analysis.
- Delegates should on completion of the course be able to identify, plan and execute requirements for efficient and complaint CAPA processes.
- How FDA and other regulatory agencies examine CAPA during inspections.
Course Format
The course presents the requirements for CAPA and RCA comprehensively, and uses case studies, interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course.
The course will include and cover:
- Nonconformity §820.90 & CAPA §820.100 requirements, and inspection under QSIT, including ISO 13485 requirements
- What makes people poor problem solvers?
- RCA tools for information analysis.
Delegates receive a "Certificate of Attendance".