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U.S. Department of Health and Human Services

Training and Continuing Education

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DG 403 - Positron Emission Tomography (PET)

 

Course Description

This training assists FDA Investigators to gain familiarity with and apply the new Positron Emission Tomography (PET) regulations 21 CFR 212, and the new CPGM to strategies when conducting PET manufacturing facility inspections.    The focus of this training is on PET production processes and system controls, including lab controls and aseptic controls.

 

Objectives

Upon completion of this course, participants should be able to:

1.  Identify key PET drug production processes.

2.  Identify PET drug material and production system controls.

3.  Demonstrate by discussion, comprehension of regulations and guidance that apply to PET drug inspections

 

Target Audience

The primary target audience is the Level 2 and Level 3 ORA investigator with experience performing drug and sterile drug inspections.   Some will have conducted PET inspections under 21 CFR 211

 

Pre-requisites

1.  Basic Radiation Safety course (RH102)

2.  Level 2 and Level 3 Investigator certification

3.  Experience performing drug / sterile drug inspections

 

CEU Credits

0.3

 

Course Duration

2.83 hours

 

Course Completion Requirements:

  1. Pre-course reading materials. Download and read the following materials prior to viewing the recorded web sessions:

§         21 CFR 212

 

§         7356.002P – PET Drugs CGPM

 

§         Media Files for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs

 

§         Download and read the following case scenarios; answer the questions to the best of your knowledge:

 

§         PET Microbiology Inspection Scenario

§         PET Production and Chemistry Scenario

 

  1. View the recorded web sessions:

 

Presentation 1 – Overview/Background

 

Presentation 2 – Inspection, Materials, Production

 

Presentation 3 – Production Equipment / Chemistry Laboratory Controls

 

Presentation 4 – Aseptic Processing / Case Scenario discussion  

 

  1. Take the test

Instructions:

§         Log into the HHSU Learning Portal (LMS) 
      either your PIV card or AMS Credentials.

§         From your home page in the LMS , select "Browse by Category". 

§         Page down to FDA ORA and select "ORA - Drugs".

§         A page with the course name and information will appear "FDAORAHQ PET Inspectional
      Strategies Exam".

§         Register for the exam.

§         Select "Launch Content" to take the exam.

§         ORA employees only – Please Note: After taking and passing the exam, please email your HHS –
      issued Certificate of Completion to Diane E. Smith at diane.smith@fda.hhs.gov to receive credit.

 

  1. Complete the post-course survey 
    http://www.surveymonkey.com/s/R95LJKS

     
  2. Download the post-course resource document for future reference. This document includes the following information:

§         PET course presenters’ contact information

§         Computerized systems information contact information

§         Reference to the Preamble to 21 CFR 212

§         Link to Radiological Health Video Training

§         Information: RH 102 -  Basic Radiation Safety Course

§         Follow-up answers to participants’ questions during the live web sessions