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EduNeering Expands GMP Curriculum for Life Science Organizations

New EduNeering courses help clients to improve employee performance, regulatory compliance, and minimize risk

June 8, 2006 - Princeton, New Jersey - EduNeering, a leading provider of knowledge management solutions to assure regulatory compliance and improve business performance, has expanded its standardized curriculum for life science organizations. Courses target knowledge needs related to Good Manufacturing Practices (GMPs) and regulatory inspections of organizations in the pharmaceutical, biologic and medical device industries. All courses have been written or reviewed by the U.S. Food and Drug Administration (FDA) under a unique formal partnership between EduNeering and the regulatory agency.

"Companies around the world rely on EduNeering's knowledge solutions to achieve regulatory compliance," said EduNeering's President and CEO Donald A. Deieso, Ph.D. "Our curriculum for the life science industry is designed to meet the specific performance, safety and regulatory requirements mandated by FDA. All EduNeering courses target job-based knowledge needs, whether for a new-hire who requires only basic knowledge about individual processes or a manager who relies on a continually updated understanding of topics ranging from corporate ethics to regulatory inspections. That approach enables employers to minimize learning time at the same time it assures them that all employee receive and comprehend the function-based knowledge needed to fulfill their job responsibilities."

EduNeering's new courses expand the company's standardized library of more than 450 courses and include the following:

• Awareness of FDA Inspections for Pharmaceutical Manufacturers: A basic primer for all employees on the inspection process and requirements;
• Principles of FDA Inspections for Pharmaceutical Manufacturers: A more advanced course focusing on issues including the authority, purpose and procedures of an FDA inspection;
• Managing FDA Inspections for Pharmaceutical Manufacturers: The most in-depth inspection-related GMP course, addressing issues required for effective management an FDA inspection including preparation before the inspection, protocol for interacting with FDA, and follow-up to an inspection;
• FDA Training and Qualification Requirements: Course focused on preventing or reducing errors/deviations, customer complaints, regulatory risk, and operational costs, while at the same time assuring compliance, performance and product quality;
• Gowning for Sterile Environments: Focused on the proper procedures for cGMP, sterilization, and the implications of distributing non-sterile products;
• GMP Principles for Batch Record: Developed for manufacturing and packaging operators involved with batch processing and its documentation;
• GMP Principles for Standard Operating Procedures (SOPs): Adherence to SOPs as a critical element to assuring the quality of drug product and medical device manufacturing.

EduNeering recently achieved its 10 millionth course completion in the life science industry. The curriculum for FDA-regulated organizations is continually updated to meet compliance and performance needs throughout all phases of product development, clinical studies, manufacturing, marketing and post-marketing studies. Used by life science organizations around the world, EduNeering's solution is supported by ComplianceWire^® , its Internet-based technology platform, which enables the distribution, validation, monitoring and recordkeeping of critical documents relating to regulatory requirements, SOPs, and corporate policies.