CAPA for the Pharmaceutical Industry

The Seven CAPA Steps
The course is based on seven easy to remember CAPA steps which when implemented will meet all of the FDA’s expectations for CAPA. A good CAPA system involves more than just taking action where failure has occurred, the Seven CAPA Steps approach gives a comprehensive approach to the implementation of a CAPA programme from the review of Quality trends through to the long term assessment of the effectiveness of CAPA actions.

CAPA Investigation
Inadequate investigation is one of the major causes of CAPA 483s at FDA inspections. This course demonstrates how to thoroughly document CAPA investigations to the FDAs satisfaction and gives delegates a toolbox of techniques that can be used to determine the root cause. Work completed during the course will allow the delegate to determine when to apply each tool for a given situation.

Correction, Corrective Action, Preventive Action
This section of the course will help the delegate to determine the true difference between Correction, Corrective Action and Preventive Action.

The section covers;

• containment and a risk assessment of issues as they arise
• how to address systemic root causes
• how to implement real preventive measures such as potential failure analysis, standardization and benchmarking.

Assessing CAPA Effectiveness
Addressing CAPA effectiveness involves three distinct activities;

• verification or validation of the solution
• assessment of the long term effectiveness of the corrective action
• monitoring the overall effectiveness of the CAPA system

This course provides the delegate with the knowledge and skills to implement the requirements pertaining to all three of these elements.

Personnel in the Pharmaceutical industry involved in any part of a CAPA system; these may include Operators, Technical Staff and Management from Production, Quality, Engineering or Support Functions.

Participants achieve the following learning outcomes from the programme;

• Implement the Seven CAPA Steps approach.
• Meet FDA and European expectations when completing CAPAs.
• Conduct thorough Investigations into the causes of failure.
• Distinguish between Correction and Corrective Action.
• Distinguish between Corrective Action and Preventive Action.
• Generate Corrective Actions that truly address the Root Causes of failure.
• Write SMART Effectiveness Checks criteria.
• Assess the Effectiveness of Corrective Actions.
• Assess the Overall Effectiveness of a CAPA system.

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  Gerry Burke

  Gerry is a self-motivated medical industry professional with kn...

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  John Lafferty

  John Lafferty, B. Tech. in Manufacturing Technology, Six Sigma ...

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In-House Courses
For In-House courses, the Tutor will contact the Course Organiser in advance to discuss the programme in more detail in order to tailor it specifically to the organisation.

Course Manual
Delegates will receive a very comprehensive course manual.