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U.S. Department of Health and Human Services

Training and Continuing Education

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ORA U Course Catalog 2013 - DEVICES

 

Course ID:      DV201
Course Title:   Basic Medical Device
 
Course Description: This course is designed to give FDA personnel who conduct, participate in, or review device inspections a basic knowledge of common medical device manufacturing processes, and the inspection of medical device manufacturers.
 
Course Objectives:
Upon completion of this course, participants will be able to:
  1. Demonstrate knowledge of the medical device laws, regulations and policies, and their applications to investigative operations.
  2. Identify and use the available FDA, intranet and internet based medical device references.
  3. Evaluate common device manufacturing processes and the control systems used to ensure compliance with the Quality System Regulation.
  4. Apply common investigational and evidence development techniques to medical device inspections.
Target Audience: This course is designed to give FDA personnel who conduct, participate in, or review inspections a basic knowledge of common medical device manufacturing processes, and the inspection of medical device manufacturers.
 
Prerequisites:
  1. Have completed the ORA New Hire training curriculum, including audit (FDA: Level I).
  2. Conducted at least one inspection of a medical device manufacturer (may be a training inspection).
  3. Successfully completed the Quality Systems Regulation courses consisting of eleven (11) courses available through ORA U Compliance Wire.
  4. Successfully completed the on-line Quality Systems Inspection Technique Courses (QSIT) consisting of five (5) courses available through ORA U Compliance Wire.
  5. Successfully completed the “Step By Step Approach to Process Validation” available through ORA U Compliance Wire.
 
Course Duration: 9.5
CEU: 6.7
 
Course ID:          DV301
Course Title:       Medical Devices: Electronics, Computers and Materials
 
Course Description: The purpose of the course is to assist the experienced field investigator in the identification of potential product issues and regulatory case development related to product design, manufacturing, testing and quality assurance requirements for medical device electronics, computers and materials.
 
Course Objectives:
Upon completion of this course, participants will be able to:
  1. Demonstrate knowledge of materials used in the manufacture of medical devices, test methods, test equipment, common product failure modes of medical devices, and failure analysis techniques.
  2. Evaluate device manufacturing processes, testing, and failure analysis documentation in conjunction with product risk.
  3. Demonstrate knowledge of investigative techniques to identify non-conforming product and to collect evidence necessary for case development.
 
Target Audience: This course is targeted to the experienced field Investigator with a minimum of five (5) years’ experience in conducting inspections (with the majority of inspectional work being performed in medical device inspections).
 
Prerequisites:
  1. Have completed their ORA New Hire training curriculum, including audit (FDA: Level I).
  2. Basic Medical Device (DV201) training course
  3. Process Validation of Medical Devices (DV303) training course
 
Course Duration: 4.5
CEU: 3.1
 
Course ID:      DV303
Course Title:   Process Validation of Medical Devices
 
Course Description: This course is designed to give FDA personnel who conduct, participate in or review medical device inspections knowledge of the fundamentals of process validation, key elements of the various validation processes, theories and concepts of process validation and how they are applied to packaging, electronic manufacturing and assembly, metal fabrication and testing; and In Vitro Diagnostics (IVD) validation processes.
 
Course Objectives:
Upon completion of this course, participants will be able to:
  1. Apply the principles of process validation and the FDA Quality System Regulation requirements for process validation during a medical device inspection.
  2. Evaluate how process validation is carried out for various manufacturing processes used in the production of medical devices.
  3. Determine if a firm has identified processes that require validation and determine if the processes have been validated according to the FDA regulations during a Quality System inspection.
 
Target Audience: This course is intended for experienced field investigators, supervisory investigators, compliance officers or Center Consumer Safety Officers, and is designed to present practical training to persons experienced in the medical device program on the fundamentals of process validation.
 
Prerequisites:
  1. Have completed the ORA New Hire training curriculum, including audit (FDA: Level I). State employees should have completed their new hire program and have experience working in the program area.
  2. Conducted at least five (5) medical device Good Manufacturing Practice (GMP) inspections, or routinely review medical device inspection reports.
  3. Completed the Basic Medical Device (DV201) training course.
  4. Completed the on-line course through EduNeering titled: PHDV79 “A Step By Step Approach to Process Validation.”
 
 
Course Duration: 4.5
CEU: 3.2