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U.S. Department of Health and Human Services

Training and Continuing Education

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ORA U Classroom Course Catalog - Multi-Program Training


ORA New Hire Training
Course ID and Title: MP101 Basic Food and Drug Law
Course ID and Title: MP102 Evidence Development
Course ID and Title: MP118 Interviewing Skills and Personal Safety Reports
Course Description: This course is designed to provide basic information on the FD&C Act to newly hired FDA employees. In addition, students are taught the basics of conducting a FDA inspection: how to collect evidence, properly maintain samples, conduct themselves on an inspection, etc.
The Interviewing Skills and Personal Safety Reports course provides the skills necessary to remain centered and focused during any verbal circumstance to redirect behavior, diffuse difficult situations, and generate voluntary compliance from people not on their best behavior. Although people may not always like what they have to do, they will understand the need to be cooperative.
 Basic Food and Drug Law (MP101) Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify and locate the appropriate statutory sections for FDA regulated commodities, sanctions provided for by the statute, and various violative categories of regulated products;
  2. Determine what is a food, drug, cosmetic, device, food additive, dietary supplement, and biological product under the applicable statutes;
  3. Interpret the meaning of certain sections of the Food, Drug, and Cosmetic Act using precedent-setting cases presented in class;
  4. Differentiate between FDA Policy, Regulation and Law;
  5. Identify the enforcement tools provided for under the statutes enforced by FDA;
  6. Identify the basic elements that must be developed to initiate import actions, seizure, injunction, criminal penalties, and license suspension or revocation;
  7. Determine how products may be violative Identify the statutory basis for inspectional and sampling authority
  8. Apply this knowledge by increasing the quality and independence of their assigned work after the course.
Course Duration: 5 Days
CEU: 3.4
Evidence Development (MP102) Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Differentiate between the various forms of evidence
  2. Identify the elements of proof for FDA cases;
  3. Identify how to properly collect physical and documentary evidence and the elements of sample integrity;
  4. Identify the qualities of a good Establishment Inspection Report, FDA 483, Affidavit, and Analyst Worksheet;
  5. Identify FDA's basic procedures for regulating imported products;
  6. Demonstrate higher quality and more independence in gathering, developing, and documenting evidence.
Course Duration: 5 Days
CEU: 3.4
Interviewing Skills and Personal Safety Reports (MP118) Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify potential and foreseeable personal safety dangers associated with FDA operations
  2. Explain the FDA Personal Safety Policy and its influence on inspections
  3. Maintain the appropriate level of awareness necessary to conduct interviews and inspections safely
  4. Apply proper interpersonal communication skills in an interview/inspection setting
  5. Recognize and diffuse the various levels of conflict and aggression
  6. Demonstrate the ability to plan and conduct an investigative interview
  7. Develop and brief a personal safety plan that will enhance personal safety and provide tools to proactively manage potentially dangerous situations
  8. Present a briefing of a personal safety plan that will enhance personal safety and provide tools to proactively manage potentially dangerous situations
Course Duration: 5 Days
CEU: 3.4
Target Audience: This course is designed for new FDA Investigators, Inspectors, and Laboratory Analysts.
Prior to attending, CSOs/CSI nominees must:
  1. Must complete the ORA U web-based training curriculum (all items except Level I Audit)http://inside.fda.gov/downloads/EmployeeResources/Training/ORAUNewHires/UCM049918.pdf
  2. Must be employed with the Agency for six (6) months minimum (nine months preferred for analysts)
  3. Must have a minimum of one independently performed Establishment Inspection (EI) or if working in a remote location, a team inspection may be substituted
  4. Must have completed their district's Laboratory tour/OJT experience (dates and lab location of OJT need to be submitted at time of nomination)
  5. Must complete the pre-course reading assigned by DHRD (prior to the course, after nomination).
  1. Must be employed with the Agency for six (6) months minimum (nine months preferred for analysts)
  2. Must complete the ORA U web-based training curriculum (all items except Level I Audit). Analysts must complete the OJT assignment under the ORA-U Web module titled "FDA Establishment Inspection" before he/she attends the Law and Evidence Development Courses
  3. Must have actively participated in a basic food, drug or device inspection.
  4. Must complete pre-course reading assigned by DHRD (prior to course, after nomination).
  5. At the time of nomination all nominees must possess the listed prerequisites to attend any ORA New Hire training Course. Exceptions to these guidelines will be taken on a case by case basis and reviewed by the assigned DHRD Training Officer and the DHRD Director.
All students MUST read Basic Food and Drug Law Pre-Course reading material before attending the course. This material can be found under the curriculums for both CSOs and Analysts. It is clearly marked MP101 Basic Food and Drug Law Pre Course Reading Materials. The materials are comprised of 5 readings.
Course Completion Requirements
To successfully complete this course and receive a course certificate with Continuing Education Units* (CEUs), each participant will be required to:
  1. Complete Course Pre-Requisites
  2. Be on time and attend the entire course
  3. Participate in class discussions, exercises, workshops and presentations
  4. Pass the course assessment(s) (Law exam, Uncle Buster Case Study and Personal Safety Plan)
Course Assessments/Exam Policy*
As an authorized provider of Continuing Education Units accredited through the International Association for Continuing Education and Training (IACET), DHRD courses are required to have an assessment(s) component (knowledge & application) to evaluate the effectiveness of the training presented and the participant’s grasp of the material covered. Participants will receive only a pass/fail score. Minimum passing score is 70%.
Course ID:           MP124
Course Title:       ORA Mentoring Program Strategic Planning
(NEW - Under Development FY13)
Course Description:
Course Objective:
Target Audience:
Course Duration: Pending
CEU: Pending
Course ID:           MP143
Course Title:      Computer Aided Inspections
Course Description: The techniques and tools emphasized in this course will provide the FDA employee with the knowledge and skills to request firm electronic data and mine vast amounts of information
Course Objectives: Participants will be able to apply Microsoft Excel, Adobe Acrobat and Microsoft Access functions to review and examine electronic data.
Target Audience: The primary target audience for the training is the new and seasoned FDA CSO in any commodity area in which electronic records are used by firms. The new CSO must have some independent inspectional experience.
• Attend New Hire Training (Basic Food and Drug Law/Evidence Development /Investigative Interviewing).
• Successful completion of Level 1 Investigator audit.
• Supervisory endorsement stating the employee has successfully completed Level I Certification.
• Review the online lectures which will be provided with adequate time before the course is delivered
Course Duration: 3 Days
CEU: 2.1
Course ID:               MP150
Course Title:          Basics of Auditing for Regulators
Course Description:  This is an introductory course designed to prepare FDA investigators, state, local and tribal inspectors, regulators, program managers and supervisors for various applications of auditing. The course will emphasize principles such as observing performance, comparing performance to criteria, and evaluating/assessing performance.
Course Objectives:   After completing the course the regulator should be able to:
  • Recognize why performance oversight of the regulatory process/function is important
  • Identify how to improve his/her assessment of others
  • Identify the skills required of performance auditors
  • Recognize the differences between assessing individuals and programs
  • Recognize the need to avoid influencing the outcome of an inspection
  • It is a copy/paste task.

Course ID:           MP219
Course Title:       Conducting ORA International Inspections   (NEW - Under Development FY13)
Course Description: This 4½ day course led by ORA and contract instructors is designed to familiarize investigators/analysts with the intricacies of FDA’s global operations and to provide investigators/analysts with their responsibilities before, during, and after international inspections.
Course Objective:
Upon completion of this course, participants will be able to:
  1. Recognize the unique aspects of FDA’s global operations
  2. Recognize the key roles in planning and accomplishing a foreign inspection
  3. Identify investigator/analyst responsibilities prior to travel
  4. Identify investigator/analyst responsibilities while on travel
  5. Identify investigator/analyst responsibilities after returning from travel
Target Audience: Investigators and Analysts Level I certified and endorsed by their management to perform international inspections for ORA. Nominees must have performed multiple inspections in the commodity area they are inspecting and also have completed basic training courses in that same commodity area.
  1. Level I certified
  2. Endorsed by District Management
  3. Performed multiple inspections in respective commodity area
  4. Completed basic training courses in respective commodity area
Course Duration: Pending
CEU: Pending