Medicom Consulting

An intensive one-day training course on how to establish and improve compliance with the GMP requirements for CAPA, and improving root cause analysis

 

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 corrections 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 13485:2003 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.

 

Course Details

The course will include and cover:
Nonconformity §820.90 & CAPA §820.100 requirements, and inspection under QSIT, including ISO 13485:2003 requirements
What makes people poor problem solvers?
RCA tools for information analysis.

 

Contact us for detailed training agenda and prices