CAPA Course for the Medical Device Industry

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Our fully interactive Corrective and Preventive Action (CAPA) training course provides attendees with all the knowledge and skills they need to comply with the CAPA-related requirements of ISO 13485 and 21 CFR Part 820. The course is fully tutor led and focuses on the practical implementation of CAPA following the Seven CAPA Steps approach. The course focuses on real life situations from the workplace. The course involves practical exercises and group working with comprehensive feedback from the course tutor throughout, so that attendees can confidently implement CAPA requirements when they return to the workplace.

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

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. New Root Cause Tools Added
Root Cause Investigation Case Study New and Updated Content

Correction, Corrective Action, Preventive Action Updated Content
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, standardisation and benchmarking.

Participants will complete practical work on a case study covering containment, risk assessment and CAPA actions. New and Updated Content

CAPA Effectiveness Updated Content
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.
Case Study on CAPA Effectiveness New and Updated Content

End of Course Assessment
This course now includes an end of course assessment. New

Personnel in the Medical Device manufacturing 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.

Gerry Burke

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

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John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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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.

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Snapshot

Course Code

LS031

Duration

2 training days

Public Price

Virtual Training: €695

(includes course documentation).

Delivery Mode

This programme is delivered by Classroom, Virtual Training, or In-Company training

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