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.
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