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U.S. Department of Health and Human Services

Training and Continuing Education

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ORAU Course Catalog 2013 - RADIOLOGICAL HEALTH

 

Course ID:              RH102 
Course Title:         Basic Radiation Safety
 
Course Description: This course is designed to meet the mandatory USNCR radiation safety training requirements for all users of radioactive materials.  The intended audience is researchers, analysts, and CSO’s who use radioactive materials or ionizing radiation producing equipment in the conduct of their job or who inspect radiopharmaceutical facilities.  This course will be in lecture format with classroom problem sessions and exercises.  General topics covered will include: Atomic Structure and Radioactivity; Basic Radiation Types and Interactions; Radiation Detection and Measurements; Radiation Biological Effects; Radiation Protection Techniques; FDA Guidelines & Procedures; and NRC Rules and Regulations.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify the common types of ionizing radiation, and discuss how they interact with matter.
  2. Define the quantities and units of radiation and radioactive decay.
  3. Discuss the biological effects of ionizing radiation.
  4. Categorize the basic processes to detect and measure radiation, and identify appropriate instruments to measure radiation.
  5. Practice the basic principles of protection from radiation.
 
Target Audience: Training course is targeted toward newly hired or newly tasked CSO’s or laboratory personnel that will be involved with the radiation safety program monitoring or working with radioactive materials.
 
Prerequisites: None
 
Course Duration: 2.5 Days
CEU: 1.7
 
Course ID:          RH104
Course Title:     Import Radiological Health
 
Course Description:
The course will familiarize import personnel with radiation-emitting products. FDA-regulated electronic products will be emphasized. This course will also cover all types of products collected and tested at the WEAC lab. Concepts of radiation protection, biological effects of ionizing and non-ionizing radiation, analytical paradigms, and a summary of laws and regulations as applied to compliance programs are included.
 
Course Objectives:
Upon completion, participants will be able to:
The course will familiarize import personnel with radiation-emitting products. FDA-regulated electronic products will be emphasized. This course will also cover all types of products collected and tested at the WEAC lab. Concepts of radiation protection, biological effects of ionizing and non-ionizing radiation, analytical paradigms, and a summary of laws and regulations as applied to compliance programs are included.
 
Objectives: Upon completion, participants will be able to:
  1. Demonstrate the basic principles of radiation protection.
  2. Identify the common type of ionizing and non-ionizing radiation produced by electronic products, along with biological effects, radiation safety considerations and WEAC analysis.
  3. Demonstrate familiarity with security screening and safety around x-ray device on docks.
  4. Demonstrate an understanding and knowledge in the use of pagers, use of dosimeters and the use of survey meters.
  5. Demonstrate basic knowledge of the imported medical devices that are tested at WEAC.
  6. Demonstrate basic knowledge in the Radionuclide analysis of imported and domestic foods and drugs.
  7. Discuss analytical criteria of imported products such as violative versus non-violative, CFR requirements and manufacturer specifications.
  8. Demonstrate an understanding and knowledge of the routine work that U.S. Customs performs focusing on radiation scanning devices.
  9. Identify the various functions of CDRH.
 
Target Audience:  This course is designed for all FDA personnel who work in imports and conduct inspections on docks, or compliance officers working on import regulatory issues.
 
Prerequisites:  Prior to attending, nominees must:  
  1. Have completed their new hire training curriculum (FDA: Level I Certification)
  2. Have conducted, completed or participated in activities related to import and dock inspections.
 
Course Duration: 3.5 Days
CEU:  2.5
 
Course ID:              RH106
Course Title:         Radiation Pager® Webinar
 
Course Description: The purpose of this web-based training is to provide instruction on the operation of the new Radiation Pager®.
 
Course Objectives:
Upon completion of this webinar, the participant will be able to:
  1. Describe the operation of the Radiation Pager.
  2. Apply knowledge gained from the Radiation Pager Webinar to their work with imported products.
 
Target Audience: This training is targeted toward FDA import personnel who work with imported products that may contain radiation.
 
Prerequisites: None
 
Course Duration: 25 Minutes
CEU: None
 
Course ID:              RH201
Course Title:         Basic Radiological Health
 
Course Description:  This course is designed to train field staff on how to perform electronic product manufacturer inspections and familiarization with field testing programs. This course will include concepts on radiation safety, medical effects of ionizing and non-ionizing radiation, overview of law and regulations and applicable compliance programs. This course will also include familiarization with applicable ORA and CDRH databases.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify the common types of electronic products, radiation, biological effects and radiation safety considerations.
  2. Demonstrate knowledge of the electronic product radiation control laws, regulations and policies, and their applications to investigative and compliance operations.
  3. Identify and use the available FDA, intranet and internet based electronic product radiation control references and IT systems.
  4. Evaluate electronic product manufacturing processes and quality control testing programs used to ensure compliance with Radiological Health Regulations.
  5. Apply common investigational and evidence development techniques to electronic product radiation control inspections.
 
Prerequisites: Prior to attending, nominees must:
  1. Have completed the ORA New Hire training curriculum (FDA: Level I, including audit).
  2. Completed Basic Medical Device (DV201) training course.
  3. Have an active TURBO EIR account and have written a 483 in TURBO.
  4. Have successfully completed the Quality Systems Regulation Courses (QSR) consisting of eleven (11) courses available through ORA U Compliance Wire.
  5. Successfully completed the on-line Quality Systems Inspection Technique Courses (QSIT) consisting of five (5) courses available through ORA U Compliance Wire.
 
Target Audience: This course is required for all radiological health investigators and compliance officers.
 
Course Duration: 4.5 Days
CEU: 3.2

 


 

Course ID:           RH301
Course Title:       Inspection of Laser Manufacturers
 
Course Description:  This course trains field investigators and engineers to perform inspections of both medical and non-medical laser manufacturers. Participants will learn how to evaluate compliance with both medical device and electronic product radiation control (EPRC) requirements.
 
Course Objectives:
Upon completion of this course, participants will be able to:
 
  1. Interpret EPRC and medical device requirements, how they are related and how they apply to medical and non-medical laser manufacturers.
  2. Conduct inspections independently by applying EPRC and if applicable, quality system inspectional techniques appropriately.
  3. Document inspectional observations that are supportable and actionable.
  4. Recommend appropriate actions for field and or CDRH follow-up.
 
Prerequisites:  Prior to attending, nominees must:
 
  1. Completed 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. Successfully completed the Basic Radiological Health course (RH201).
 
Target Audience:   Primary audience: Consumer Safety Officers, Engineers, and Compliance Officers. Supervisory Consumer Safety Officers and Center reviewers will be admitted on a space available basis.
 
Course Duration: 3 Days
CEU:  Pending

Course ID:           RH303
Course Title:      Inspection of X-Ray Manufacturers
 
Course Description:  This course trains field investigators and engineers to perform inspections of x-ray and component manufacturers. Participants will learn how to evaluate compliance with both medical device and electronic product radiation control (EPRC) requirements.
 
 Course Objectives:
Upon completion of this course, participants will be able to:
 
  1. Discuss medical device and EPRC requirements, how they are related and how they apply to x-ray device/component manufacturers.
  2. Conduct inspections independently and make defensible observations using EPRC criteria applied to the QSIT technique.
  3. Prepare an EIR and develop supportable evidence for field, CDRH, and post-inspection activities.
 
Target Audience:  Primary audience: Consumer Safety Officers, Engineers, and Compliance Officers. Supervisory Consumer Safety Officers and Center reviewers will be admitted on a space-available basis.
 
 Prerequisites: Prior to attending, nominees must have:
  1. Completed 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. Successfully completed the Basic Radiological Health course (RH201).
 
 
Course Duration: 3 Days
CEU:  Pending