Technical tools and knowledge required to operate and manage in medical  devices manufacturing environment.  Current requirements in medical devices  regulations, quality systems, and design elements related to manufacturing  steps to assure patients health and safety.  Requirements concerning  selection and supply of raw materials and components for manufacturing; design  and qualification of facilities, equipment, and process systems; testing,  controls and inspection for compliance.  Combination products, validation,  external contractors, and case studies.  Focus on understanding the principles  and methods required in a medical devices manufacturing environment in  compliance with GMP regulations.