Manufacturing

Kaplan EduNeering works with medical device companies to enable compliance with regulatory requirements -- while optimizing enterprise-wide operations and resource efficiency.

Authoritaive Online Courses
Our programs consist of online courses that are authored and reviewed by the FDA, and also reviewed by AdvaMed, facilitating compliance with FDA’s most current requirements and expectations.

Courses can organized into curricula based on a learners's role, so that training requirements can be mapped according to job specifications. This approach allows our clients to improve resource planning while setting career paths for employees.

Manage Multiple Training Types with One LMS
Our ComplianceWire learning management system (LMS) provides robust capabilities for the generation, distribution, tracking and documentation of regulatory training, on-the-job skills, SOP training, and corporate policies and procedures. We leverage the SaaS model, which greatly reduces the burden on IT while enabling data storage in a secure data center.

The LMS can be integrated with mission-critical systems, providing quality assurance and compliance. For example, LMS integration with manufacturing can prevent an operator from using a machine until he or she has completed all of the necessary training.

Kaplan EduNeering assists companies in the following areas:

  • Global compliance training
  • GMP, QSIT and QSR programs
  • Employee and vendor qualification and certification
  • CMO and contractor training, documentation and management
  • Audit-ready documentation of all compliance training activities
  • SOP, critical information distribution and validation via e-signature
  • Remediation of CAPA incidents
  • Integration with document management, HRIS, MES and ERP systems