Manufacturing

Kaplan EduNeering works with medical device companies to enable compliance with regulatory requirements while optimizing enterprise-wide operations and resource efficiency. Our comprehensive medical device quality and manufacturing programs consist of online courses that are authored and reviewed by the FDA, and reviewed by AdvaMed, facilitating compliance with FDA’s most current requirements and expectations. Programs are role-based with curricula and training requirements 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. Since our LMS is hosted, it minimizes the use of a client’s internal IT resources while enabling data storage in a secure database with 24/7 access to designated personnel for program monitoring, management and control. Increasingly, we are delivering integrated solutions to our device clients that assure utmost quality throughout their operations —for example—a machine or process will not activate unless the operator has demonstrated via the LMS that they have achieved all 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
Product quality assurance and control