Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture

A company’s Corrective and Preventive Action (CAPA ) system establishes how personnel should deal with manufacturing problems that have occurred or that may occur if not prevented. This module explains the principles of corrective and preventive action and describes typical CAPA procedure. It goes on to introduce root cause analysis and outline the role of progress tracking, escalating, and trending of CAPA procedures.

Module overview - An outline of the module’s scope and objectives, and notes on terminology.

CAPA principles - In this session we explain what a CAPA system is and why it is important. We explain the dierences among correction, containment, corrective action, and preventive action. We specify sources of information about manufacturing problems, and we emphasise the importance of documentation of aCAPA system.

CAPA procedure - Problems that may give rise to CAPAs are best tackled by systematically progressing through a number of stages of procedure. In this session we set out the typical stages of a CAPA procedure, along with the questions to be addressed and the actions taken at each stage.

Root cause analysis - Root cause analysis is a rigorous approach to finding the deepest causes of problems. In this session we emphasise the value of applying CAPA to root causes rather than their symptoms. We set out the stages of a typical analysis, and we list examples of tools for finding causes and studying trends.

Tracking, escalation, and trending - One of the most common findings of regulatory inspectors is the lack of effective and timely closure of CAPA reports. In this short session we emphasise the importance of tracking the progress of CAPA procedures, escalating issues, and reviewing trends in the CAPA system.

This module provides essential training for all personnel who work in a manufacturing environment in the pharma/biotech industry.

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1. What is included with the course?
Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included and this will vary by course.

2. Can I pause the course and log in to it anytime?
Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 365 days).

3. Are there any quizzes in the middle of the course?
Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist.

4. Can I get a refund if I cancel my enrollment?
Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation.

5. What happens if I don’t finish the course within the access period?
The standard access period is 365 days to allow sufficient time to complete your course.