Biotility: Corrective Action Preventive Action (CAPA)

Describes regulatory requirements for a CAPA system in the biotech industry.

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About this Course

A robust Corrective Action Preventive Action (CAPA) system is an integral component of a company’s Quality Management System.

This course describes U.S. Food and Drug Administration regulatory requirements for a company’s CAPA system, including mitigating nonconformances and using root cause analysis to formulate a corrective action plan, then implementing preventive action plans to deter unknown nonconformances. Learners will consider how CAPA plans and processes can avert recurrence of similar potential problems before they occur and ensure they do not happen again. In addition to the lecture component of the course, the presenter also reviews scenarios requiring CAPA and strategies for implementing the CAPA process.

Experienced industry professionals developed this Biotility: Corrective Action Preventive Action (CAPA) course to ensure that personnel conducting CAPA processes are informed of regulatory requirements and methods utilized to investigate, mitigate, and prevent nonconformances. This course ensures personnel understand the importance of CAPA in their assigned role, and are aware of the consequences of non-compliance. CAPA is a crucial part of quality management, assessing risks, auditing, and recall procedures.

Biotility: Corrective Action Preventive Action (CAPA) course is tailored to the biotech industry service providers and personnel involved in the manufacture and/or testing of (bio)pharmaceutical products and devices. This includes, but is not limited to, personnel working in: Quality Management, Quality Assurance, Risk Management, Quality Control, Document Control, Manufacturing, Materials Control, Process Development, Assay Development, and cGMP-compliant environments.

Note: This Biotility at the University of Florida course is offered by CITI Program. See FAQs below for more information.
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Course Preview:

Language Availability: English

Suggested Audiences: Biotech industry service providers and personnel involved in the manufacture and/or testing of (bio)pharmaceutical products and devices. This includes, but is not limited to, personnel working in quality management, quality assurance, risk management, quality control, and document control as well as process development, assay development, and cGMP-compliant environments

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $124.76 per person

Demo Instructions


Course Content

Corrective Action Preventive Action (CAPA) - Module 1

This module introduces CAPA principles and overviews FDA guidance. It differentiates the terms “correction” and “corrective action” as well as distinguishes “preventive action” from corrective. It discusses where CAPA fits within a quality management system and the importance of creating a CAPA system. The module also reviews audits and inspections processes.

Recommended Use: Required
ID (Language): 20669 (English)
Author(s): Travis Arola, MS, RAPS - National Resilience, Inc.

Corrective Action Preventive Action (CAPA) - Module 2

This module covers FDA expectations for implementing CAPA systems and consequences of noncompliance. It describes root cause investigations and applications for correcting a problem. Further, the module covers cGMP regulatory concepts such as investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. The module concludes with a review of FDA warning letters for lessons that can be learned.

Recommended Use: Required
ID (Language): 20670 (English)
Author(s): Travis Arola, MS, RAPS - National Resilience, Inc.

Corrective Action Preventive Action (CAPA) - Module 3

The final module in this course reviews and examines stages of the CAPA process using a hypothetical example of a nonconformance. The presenter discusses a case study that uses a CAPA process to address potential problems that may arise in cGMP-compliant manufacturing. The module discusses the importance of long-term CAPA procedures, including closure, tracking, and trending.

Recommended Use: Required
ID (Language): 20671 (English)
Author(s): Travis Arola, MS, RAPS - National Resilience, Inc.


FAQs

Who should take the Corrective Action Preventive Action course?

The Biotility: Corrective Action Preventive Action (CAPA) course is tailored to biotech industry service providers and personnel involved in the manufacture and/or testing of (bio)pharmaceutical products and devices. This includes, but is not limited to, personnel working in:

  • Quality Assurance
  • Risk Management
  • Manufacturing
  • Quality Control
  • Materials Control
  • Document Control
  • Research and Development

What are the benefits of this course?

This Biotility: Corrective Action Preventive Action (CAPA) course was developed by experienced industry professionals to ensure that personnel conducting CAPA processes are informed of regulatory requirements and methods utilized to investigate, mitigate, and prevent nonconformances. This course ensures personnel understand the importance of CAPA in their assigned role, and are aware of the consequences of non-compliance. CAPA is a crucial part of quality management, assessing risks, auditing, and recall procedures.

How long will the course take to complete?

The Biotility: Corrective Action Preventive Action (CAPA) course consists of three modules. Completion of all modules, as well as the corresponding quizzes should take 140 to 190 minutes.