UL EduNeering, a provider of knowledge management solutions to assure regulatory compliance and improve business performance, has released its 45-course FDA Inspections and Enforcement Curriculum. The curriculum was co-developed by UL EduNeering and the U.S. Food and Drug Administration (FDA) under the organizations’ unique Cooperative Research and Development Agreement (CRADA). Under the CRADA, EduNeering provides the on-line training, documentation and technology-enabled management system used by the agency’s inspectors and investigators. That same solution and curriculum is available exclusively to EduNeering’s pharmaceutical, biopharm, and medical device clients.
The curriculum is organized into five functional areas:
- Basics of Inspection: Twenty courses provide instruction on all aspects of preparing for, conducting
and following up on FDA inspections.
- Import Operations: Coursework focuses on import-specific requirements related to FDA compliance,
inspections and responses to requests for additional information.
- Quality System Regulations and Inspections: Courses range from the manufacturer’s responsibility
for a quality system to a framework for Corrective And Preventive Action (CAPA).
- Risk Management: Specialized coursework enables understanding of current FDA interpretation of
risk management as defined by the International Organization for Standardization (ISO).
- Validation and Part 11 Compliance: Targeted validation, documentation requirements and compliant actions based on Part 11 regulations are covered.