Corrective and Preventive Action (CPAP) Requirements Training

Course Duration: 2 Days

This two-day seminar covers all phases of initiating CAPA from non-conformances through implementation and effectiveness verification of the corrective actions. The Standards from which this training has been derived are ISO 13485 and 21 CFR 820, as well as other world-recognized standards.

Risk Management is addressed as integral to the CAPA processes and must be integrated into the selection of appropriate mitigation or corrective processes. All will be in accordance to ISO 14971.

The concept of Preventive Action will be discussed, and correctly interpreted to be an independent process, which may not be required or tied to each Corrective Action

Learning Objectives

  • Demonstrate an ability to complete all actions required of the CAPA process for correcting non-conformities.
  • Explain the relationship of all the different facets of the correction, corrective action and preventive action processes
  • Evaluate corrected non-conformities to determine the effectiveness of the CAPA process.
  • Demonstrate the linkage between CAPA and risk management processes

Course Outline

  • Introduction, Scope and Definitions
  • Differences between Corrective & Preventive Actions
  • Overview of CAPA expectations (FDA/ISO standards).
  • Planning
  • Measurement and Analysis (Assessment of Risk)
  • Improvement

o Identification of Root Cause(s)

o Preventing Human Error

o Actions/Mitigation prepared and approved

o Implementation of corrections and Corrective Actions

o Verification of Corrective Actions

o Effectiveness of changes

  • Input to Management

o Report to management

o Management Review

  • Preventive Action/Risk Management and the QMS
  • What’s in a Form?
  • Omnex Software Solutions

Who Should Attend

This seminar is designed for individuals and teams who are responsible for identifying resolving root causes, implementing corrections, and eliminating non-conformities via the CAPA process.

Course Materials

Each participant will receive a seminar manual, including a complete package of CAPA worksheets and checklists for each step of the process, as well as an breakout exercise materials.

Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.


Participants should possess the ability and/or desire to brainstorm and work with small groups & individuals to identify corrections, root-causes, corrective action and get buy-in from management for the approval of same. It will be necessary to work with others in a cooperative and productive manner to achieve all planned objectives.

Upcoming Training