Training Services

As part of their projects and consulting engagements, The Hollis Group strives to transfer knowledge to their clients’ professional staff. This skills transfer can take the form of mentoring, formal classroom training or a combination of both. In the classroom setting, Hollis’s instructors are thought leaders, all of whom have had extensive industry experience in the subject areas they teach. Most of them have developed or helped to develop the course and lab materials.

Hollis can develop custom training programs to meet client’s specialized needs, particularly in the areas of information systems and methods, and clinical logistics, operations and quality. Hollis also has an extensive library of standard course materials that are kept current with emerging technology and regulation. Some of these include:

• Regulatory Compliance for IT Development and Infrastructure Staff
• Life Science IT Development Using IEEE©-Based Prototyping Methods
• Life Science IT Deployment of COTS Systems Using IEEE©-Based Methods
• Electronic Records and Signatures Compliance – Annex 11, 21 CFR 11, et al
• System Testing and Traceability From Requirements Through Design
• Document Management System Requirements, Design, Operation and Audit
• Change Management System Requirements, Design Operation and Audit
• The Clinical CMO (Contract Manufacturing Organization) Workflow Processes
• The Clinical CSO (Contract Services Organization) Logistics Workflow Processes
• Recalls of Marketed Products – Causes, Classes and Consequences