Project Management Skills for an Effective CAPA

Corrective and Preventive Action (CAPA) continues to be one of the top two causes of 483s from the FDA. Those who work on CAPA should have CAPA project management skills.

Poject management skills for an effective CAPAs are the competencies and traits a person needs in order to effectively coordinate a CAPA project from start to finish. A CAPA project manager leads a projects team using good communication, interpersonal skills, motivational skills, and organization. Project management is a simple term but it encompasses a wide range of skills and responsibilities. CAPA project management includes planning CAPA phases, mapping out CAPA phases timelines, and executing each phase of the CAPA project.

This course provides delegates with a comprehensive understanding of the project management skills the CAPA owner or “project” manager should have to lead the suuessful completion of an effective CAPA.

On completion of this training, participants will be able to:

• Define project management key terms and fundamental concepts.
• Understand why a CAPA should be viewed and managed as a “project”.
• Understand the different phases of a CAPA project.
• Explain different project management concepts related to CAPA project planning and CAPA project success.
• Develop a communications management plan based on CAPA stakeholder’s needs.
• Define CAPA scope using a work breakdown structure (WBS).
• Create a realistic, defensible CAPA project schedule.
• Plan for CAPA project change.
• Manage CAPA closing processes

Personnel in the Medical Device sector involved in running and managing a CAPA.