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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 - IMPORTS

 

 

Course ID:  IM116 (Formerly IM216)
Course Title:  Import Operations and Entry Review
 
Course Description:  This is an introductory level course to prepare individuals to conduct import investigations. It stresses the practical application of import law, policies and procedures of import investigations, and examination and sampling techniques. It will also prepare individuals to conduct entry reviews on all FDA regulated products with direct feedback from the Centers and the Division of Import Operations and Policy to make risk based decisions to determine admissibility of regulated products.
 
Course Objectives:
  1. Identify regulatory requirements of imported products.
  2. Identify regulatory support systems for imported products.
  3. Explain entry review of imported products.
  4. Explain examination and sampling of imported products.
  5. Demonstrate the use of databases associated with import entries.
  6. Identify various counter terrorism indicators.
  1. Discuss quality characteristics of various types of imported biologics, entry review of these products, and their regulations.
  2. Discuss quality characteristics of various types of imported drugs and drug products, entry review of these products, and their regulations.
  3. Discuss quality characteristics of various types of imported devices, entry review of these products, and their regulations.
  4. Discuss quality characteristics of various types of imported radiological health products, entry review of these products, and their regulations.
  5. Discuss quality characteristics of various types of imported food products and cosmetics, entry review of these products, and their regulations.
  6. Discuss quality characteristics of various types of imported tobacco products, entry review of these products, and their regulations.
  7. Discuss quality characteristics of various types of imported veterinary products, entry review of these products, and their regulations.
  8. Discuss quality characteristics of various types of imported combination products, entry review of these products, and their regulations.

 

 
Target Audience: This course is designed for CSO’s, CO’s, DCB’s, DIOB’s and IPM’s who perform import work.
 
Prerequisites: Prior to attending, nominees must:
Have completed their ORA New Hire training curriculum (FDA: Level I, including the audit, or completion of six (6) month district training program (includes 3 week ORA New Hire training curriculum) if hired prior to January 1, 2002 and not Level I.
 
Course Duration: 9.5 Days
CEU: 7.1

Course ID:          IM212
Course Title:      Advanced Import Investigations
 
Course Description:  This course is designed to provide those who work in the Import Operations Branch (IOB) with specific skills and tools needed to make effective and equitable regulatory decisions about FDA and Customs and Border Protection (CBP) penalty actions on violative imported products. Some of the specific skills and tools include coverage of FDA and CBP laws and regulations, CBP operations, evidence development, applied thinking, import investigations, overview of the legal issues that impact imports, FDA/CBP collaborative issues and Office of Criminal Investigations (OCI) activities. Instructional strategies include interactive group discussions, and classroom exercises.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify available sanctions under the Food, Drug & Cosmetic Act and Title 19 (US Customs and Border Protection administrative penalties).
  2. Investigate and develop evidence to support a broad range of enforcement actions against import violators.
  3. Identify and apply the principles of critical thinking to solve import issues and problems.
 
Target Audience: 
Primary Target Audience:
Individuals who have one (1) year or more working in the Import Operations Branch (IOB) or the Division of Import Operations (DIO) and have completed IM216 or IM116 Import Operations and Entry Review course.
 
Secondary Target Audience:
Individuals who perform 25% or more of their work on products that originated in import status and/or have completed the IM216 or IM116 Import Operations and Entry Review course. A one paragraph rationale must be submitted for those that haven’t completed IM216 or IM116, or do not actively work in the Import Operations Branch (IOB).
 
Prerequisites:
1. Have completed their ORA New Hire training curriculum {FDA: Level 1 or completion of six
    (6) month district training program (includes 3 week ORA New Hire training curriculum) if   
    hired prior to January 1, 2002 and not Level 1}.
2. One (1) year or more in the Import Operations Branch (IOB) or perform 25% or more of
    investigations on product that originated in imported status.
3. Successfully completed the IM116 Import Operations and Entry Review (or former IM216)
    course.
4. Successfully completed the following Food and Drug Law on-line courses:
       a.   FDA01 Food and Drug Law: FDA Jurisdictions
       b.   FDA02 Food and Drug Law: Prohibited Actions
       c.   FDA03 Food and Drug Law: Judicial Actions
       d.   FDA04 Food and Drug Law: Criminal Acts Violations
       e.   FDA05Food and Drug Law: Imports and Exports
 
Course Duration: 4.5 Days
CEU: 3.3
 
Course ID:           IM214
Course Title:       Field Examination Using the Counterfeit Detector
 
Course Description: The course is designed to enhance import personnel’s ability to detect suspected counterfeit imported products and/or packaging using a variety of technologies. The course will heavily focus on the use of the Counterfeit Detector (version 1 and higher).   Participants will gain familiarity with the device through lectures and hands-on exercises.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Operate the Counterfeit Detector (version 1 and higher)
  2. Evaluate imported products and/or packaging using the Counterfeit Detector;
  3. Differentiate between suspected counterfeits and authentics;
  4. Illustrate and explain results of findings
 
Target Audience:
First Priority:
Individuals who are currently working in the Import Operations Branch (IOB), International Mail Facilities (IMF’s), Courier Hubs, or the Division of Import Operations (DIO) and have completed IM216 or IM116 Import Operations and Entry Review course.
 
Second Priority:
Individuals who perform 25% or more of their work on products that originated in import status and/or have completed the IM116 Import Operations and Entry Review course. A one paragraph rationale must be submitted for those that haven’t completed IM216 or IM116, or do not actively work in the Import Operations Branch (IOB).
 
Prerequisites: Prior to attending, nominees must have:
  1. Completed their ORA New Hire training curriculum (FDA: Level I or completion of six (6) month district training program (includes 3 week ORA New Hire training curriculum) if hired prior to January 1, 2002 and not Level I.
  2. Completed IM216 or IM116 Import Operations and Entry Review course.
 
Course Duration: 4 Days
CEU: 2.8