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Kaplan EduNeering Introduces FDA Inspections and Enforcement Curriculum
New curriculum gives life science companies the resources to proactively address FDA compliance and inspection requirements
June 12, 2007 - Princeton, New Jersey - Kaplan EduNeering, a leading 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 Kaplan 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.
“This curriculum provides the necessary knowledge for life science companies to work with FDA in advance of, during and following an inspection,” said Denise Queffelec, Kaplan EduNeering’s Life Science Practice Leader. “It provides companies with the tools to ensure employee proficiency and regulatory compliance by focusing directly on the knowledge needs, not only to avoid costly missteps during an inspection, but also to build a culture of compliance.” The curriculum is organized into five functional areas:
- Basics of Inspections: 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.
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About Kaplan EduNeering: Kaplan EduNeering (www.kaplaneduneering.com), a Deloitte Technology Fast 500 Company, is part of Kaplan, Inc., a leading international provider of educational and career services that is a subsidiary of The Washington Post Company (NYSE: WPO). Kaplan EduNeering develops technology-enabled knowledge solutions for improving business performance and assuring regulatory compliance. The company serves more than 200 clients in the life sciences, healthcare, energy and industrial sectors using proprietary platforms that integrate business, learning and technology. Kaplan EduNeering is headquartered in Princeton, NJ, and has offices in Houston, TX, Bloomsburg, PA, and London, UK.
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