• Pharmaceutical / Biotechnology / Biologics
  • Clinical Trials
  • Manufacturing
  • Sales & Marketing
  • Pharmacovigilance and Safety Plans (REMS)
  • Supply Chain / Subcontractor Management
  • Ethics & Corporate Responsibility
  • Case Studies
• Medical Device
• Health Care
• Energy
• Engineering & Construction
• Manufacturing & Services
• Government & Non-Profits

Hundreds of pharmaceutical, biotechnology and biologics facilities around the world rely on Kaplan EduNeering to assure regulatory compliance, product safety and workforce productivity in a fast-changing global economy. We support our clients through services tailored to the specialized requirements of clinical trials, manufacturing operations, sales and marketing, and post-marketing activities. Our combination of educational resources, technologies and services provide a robust and cost-effective solution that enables enterprise-wide knowledge transfer and facilitates compliance with US and global regulatory agencies and organizations including FDA, EMEA, ICH and ISO.

21 CFR Part 11-Validated Learning Management System

ComplianceWire®, Kaplan EduNeering’s 21 CFR Part 11-validated learning management system (LMS), and our extensive curricula targeting the knowledge needs of the industry, are developed and used by the US Food and Drug Administration to train, test and certify its investigators. ComplianceWire is hosted solution, providing a proven outsourced model that imposes minimal capital, labor or maintenance cost on our clients while assuring availability and security.

FDA-Authored Content

The same technology and curricula used by FDA are available exclusively to Kaplan EduNeering’s clients. All standard courses, including those comprising our GCP, GMP, QSR and Pharmacovigilance curricula, are authored or reviewed by FDA under a unique partnership between the agency and Kaplan EduNeering. Additional clinical courses are co-developed with the Association of Clinical Research Professionals (ACRP), a global association comprised of more than 20,000 individuals dedicated to clinical research and development under an exclusive partnership. Courses are updated regularly to reflect the most current regulatory requirements. Customized courses, whether based on our courses or developed exclusively for an individual client, support targeted objectives such as strengthening a global corporate culture, achieving enterprise-wide regulatory compliance, and minimizing risks to patients, employees and company shareholders.

Our technology is routinely integrated with other business critical systems including human resource information systems, document management and enterprise resource planning to create a turnkey infrastructure for compliance and business management.

• Kaplan EduNeering’s solution supports initiatives by companies, contract research organizations (CRO), and contract manufacturing organizations (CMO) in areas as diverse as:
• Global and national regulatory compliance
• New hire orientation and employee development
• Management of contractors and outsourced business process personnel at CROs/CMOs
• Assimilation of acquired personnel
• Part 11 validation and audit-ready documentation
• Reinforcing ethical values and behaviors
• Ensuring patient and product safety
• Risk assessment and mitigation