• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Training and Continuing Education

  • Print
  • Share
  • E-mail

ORA U Classroom Course Catalog - Veterinary Medicine

 

Course ID:           VM101
Course Title:       Grain and Feed Mill Operations
 
Course Description: This course provides an overview of the basic principles in grain and feed processing and technology. Information presented will include overviews in animal agriculture and grain storage and processing. A basic understanding of the feed industry, including feed formulation, risk analysis and feed processing will also be covered. In addition, safety protocols will be covered and a hands-on laboratory will be conducted in a feed mill production facility.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify grain storage structures and understand how grain is transported throughout the US.
  2. Delineate animal agriculture and the relationship between feed manufacturing and animal agriculture.
  3. Define and identify the key ingredients utilized in feed formulation.
  4. Identify risks associated with feed ingredients and feed production including prevention.
  5. Identify equipment used in feed handling and manufacturing and understand the primary functionality of each component.
  6. Understand safety protocols and how they relate to safety inspections.
 
 
Target Audience:  This course is designed forFDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in feed and grain inspections or review or take compliance actions on these inspection reports.
 
Prerequisites: Prior to attending, nominees must:
  1. Have completed the 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; State: Animal Feed Regulatory Program Standards are currently under development.
  2. Have conducted, completed or participated in at least one feed mill inspection, tissue residue inspection, or BSE inspection or have previous experience with feed mill inspections, tissue residue inspections, or BSE inspections.
 
Course Duration: 4.5 Days
CEU: Pending
 
Course ID:           VM201
Course Title:       Tissue Residue
 
Course Description: The course is designed for regulatory program personnel who are involved with tissue residue violations, and participants will acquire skills and knowledge in gathering, developing, and documenting evidence during investigations. Topics with livestock, dairy and poultry will include investigational techniques, regulations, polices, residue sources, extra label use of veterinary drugs, and include production and marketing practices of animal derived foods.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
 
  1. Identify appropriate investigative and data gathering techniques for conducting on-farm investigations of violative tissue residues.
  2. Identify the documentation required for the development of a successful enforcement action.
  3. Recognize animal diseases, types of drugs used to treat these diseases, animal management practices for the various food-animal production classes, the causes of drug residues, and the development and implementation of prevention strategies.
 
Target Audience: Federal and State Regulators (investigators, inspectors, and compliance officers) conducting tissue residue investigations.
 
Prerequisites: None
 
Course Duration: 4 Days
CEU: Pending
 
Course ID:           VM205
Course Title:       Residue Violation Information System
 
Course Description: This course will train new system users on all aspects of data entry, queries, and reports. RVIS responsibilities for District Program Monitors will be clearly identified and explained. The course will update current District Program Monitors and their back-ups on RVIS enhancements under ORACLE 6i as well as the use of new reports and queries.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
 
  1. Access Food Safety and Inspection Service-reported violator information from the Residue Violation Information System
  2. Identify patterns of egregious violations
  3. Add Federal/State inspectional information
 
Target Audience: Residue Program Monitors and their designated back-ups.
 
Prerequisites: None
 
Course Duration: 3 Days
CEU: Pending
 
Course ID:           VM206
Course Title:       Medicated Feed
 
Course Description: This course is designed for regulatory program personnel who are actively involved in medicated feed programs. Participants will acquire skills and knowledge in medicated feed GMP’s, critical control points pertaining to the manufacturing of quality medicated feeds, and proper reporting of significant deviations from GMP’s during medicated feed inspections. Also included will be discussions of the BSE regulation and inspection requirements.
 
Course Objectives:
Upon completion of this course, the participant will be able to:   
 
  1. Differentiate between the regulations that apply to FDA-licensed medicated feed mills and those regulations that apply to unlicensed feed mills.
  2. Determine when drug assays are required.
  3. Develop the knowledge of record-keeping requirements that apply to medicated feed mills.
  4. Identify recent developments in the medicated feed arena.
 
Target Audience: FDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in medicated feed inspections or review or take compliance action on these inspection reports.
 
Prerequisite:  Prior to attending, nominees must:
  1. Completion of the ORA New Hire training curriculum prior to attending (FDA: Level I)
  2. Previous experience with medicated feed inspections or participate in at least one (1) joint “medicated or non-medicated” feed mill inspection.
 
Course Duration: 3 Days
CEU: Pending
 
Course ID:           VM207
Course Title:       AMDUCA/Compounding of Drugs for Use in Animals
 
Course Description: This course examines the allowable practices in compounding of and extra label use of veterinary medicinals and is constructed so that investigators understand the laws, regulations and policy that distinguish animal from human drug compounding. The course examines Extra-label drug use practices that may result in violative food animal tissue residues. Investigators will gain an understanding of under what circumstances extra-label drug use can or cannot be utilized in veterinary medicine.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
 
  1. Describe the regulations and guidance documents that address the proper use of animal drugs, the compounding of drugs for use in animals, and the extra label use of drugs in animals.
  2. Recognize appropriate investigative and data gathering techniques for conducting investigations of compounding pharmacies, veterinarians and food animal producers.
  3. Correctly complete the documentation required for the development of a successful enforcement action.
 
Target Audience: This course is intended for state, local and FDA field investigators who inspect animal drug compounding pharmacies and veterinarian extra label drug use in the practice of veterinary medicine in food producing animals.
 
Prerequisites: Participants must have previous experience on inspections involving animal drugs.
 
Course Duration: 2-3 Days
CEU: Pending
 
Course ID:           VM212
Course Title:       BSE/Feed Establishments Audit
 
Course Description: This course will provide background information and a historical perspective of the state contract auditing process for BSE and/or feed establishment inspections. Classes include lectures and exercises that introduce draft audits forms, as well as instruction on how to prepare for and conduct audits.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
 
  1. Identify procedures that are followed to conduct efficient and objective audits of State inspectors who conduct inspections under an FDA BSE/Feed Establishment contract.
  2. Apply audit principles to identify and assess areas for improvement observed during the state contract inspection.
  3. Define the responsibilities and roles of both the auditor and the auditee.
 
Target Audience: FDA investigators, BSE and/or Feed Establishment State Contract/Program Monitors and Federal, state and local regulators conducting contract BSE and/or Feed Establishment inspections.
 
Prerequisites: None
 
Course Duration: 2.5 Days
CEU: Pending
 
Course ID:           VM213
Course Title:       BSE Inspection
 
Course description:
This course is intended to instruct state and FDA field investigators on how to conduct and record inspections under the ruminant feed ban regulation, 21 CFR 589.2000
Bovine Spongiform Encephalopathy (BSE) is the bovine form of a group of fatal neurological diseases known as Transmissible Spongiform Encephalopathies (TSEs).   BSE is spread through the feeding of infected material to cattle. BSE is a public health issue for the U.S. because it has been linked to the human TSE known as variant Creutzfeldt-Jakob Disease (vCJD), presumably through people consuming ruminant tissues infected with the BSE agent.   In addition, BSE has had a devastating economic effect on the livestock industry in countries where it has been identified or suspected.
On August 4, 1997, the “Animal Proteins Prohibited from Use in Animal Feeds” regulation, 21 CFR §589.2000, became effective. This regulation, designed to prevent the establishment and amplification of BSE through animal feed, prohibits the use of certain proteins derived from mammalian tissue in the feeding of ruminants, and affects renderers, protein blenders, commercial animal feed manufacturers, distributors (including retailers), transporters of animal feed and feed ingredients, on-farm animal feed mixers, and ruminant feeders.
 
A second regulation, affecting primarily renderers, became effective April 27, 2009. This new rule, 21 CFR 589.2001, prohibits certain cattle materials from being included in any animal feed. The new rule primarily impacts rendering facilities. Although primarily affecting renderers, this rule will also impact feed manufacturers, so it is important for all inspection personnel to be familiar with the basic requirements of this rule.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Describe the inspection basics of Compliance Program Guidance 7371.009, “BSE/Ruminant Feed Ban Inspections” relating to:
     a.      prohibited materials not to be used in ruminant feeds
     b.      definitions of renderer/transporter/distributor/feed manufacturer and
              ruminant feeder.
     c.      major inspectional questions to ask. Does the firm:
     d.      receive / process prohibited material?
     e.      handle prohibited material?
     f.       label feed with prohibited material with proper cautionary statements?
     g.      conduct the required recordkeeping?
     h.      avoid commingling of prohibited materials with non prohibited materials?
  2. Accurately complete the FDA checklist, “Report of Inspection for Compliance with 21 CFR 589.2000, based on informational scenarios provided by the instructors.
 
Target Audience: Federal, state and local regulators conducting inspections of firms subject to the ruminant feed ban regulation as outlined in 21 CFR 589.2000.
 
Prerequisite: Participants must have previous experience on conducting inspections under the ruminant feed ban regulation.
 
Course Duration: 1 Day
CEU: Pending
 
Course ID:           VM307
Course Title:       Real Time PCR for the Detection of Ruminant Mitochondrial DNA in Animal Feed and Feed Ingredients (NEW – Under Development FY13)
 
*Note: This course replaces the VM306 Molecular and Microscopic Analysis of Feeds for the Detection of Processed Animal Proteins which utilized conventional PCR and has become obsolete with the new method in VM307 which utilizes Real-Time PCR.
 
Course Description:   
This is an advanced course dealing with the latest techniques for the detection of processed animal proteins in feeds using molecular techniques.
 
Course Objectives:
Upon the completion of this course, the participant will be able to:
 
  1. Conduct Real-Time PCR analysis and contrast the difference between conventional and Real-Time PCR
  2. Demonstrate the ability to perform Real-Time PCR using purified DNA
  3. Demonstrate the ability to perform Real-Time PCR on DNA extracted from spiked feed samples
  4. Sample preparation
  5. Extraction of DNA from feed and/or feed ingredients
    a.      Levels of animal DNA present are different
              i.      Finished feed less than or equal to 1% meat and bone meal
              ii.      Ingredients ~ 100% animal protein
  6. Prepare master mixes
  7. Extraction of DNA from U.S. and E. U. rendered animal proteins
  8. Illustrate basic concept and principles of conventional PCR and Real-TimePCR
  9. Differences between different Real-Time PCR units
  10. Understanding and interpreting results from Real-Time PCR
  11. Need for positive and negative controls
  12. Determining amplicon identity
  13. Melt-curve analysis
  14. Identify and contrast the rendering process and how it may affect the analysts’ ability to detect processed animal proteins U.S. vs. E.U.
  15. Any animal product found it is in violation
 
Target Audience:  Analysts with both Molecular and/or Microscopic experience, which are currently, or will be involved in the detection of processed animal proteins in animal feed and feed ingredients.
 
This course is for the advanced FDA regulatory analyst. Nominees will be screened for experience in PCR analytical experience.
 
Prerequisite: One (1) year of molecular and/or microscopic experience in the BSE/Ruminant Feed Ban Program.
 
Post-course Assessment: Utilizing the RT PCR method established by CVM, each participant will need to examine a BSE sample in their home laboratory. The post-course assessment instructions and form will be given to the participants at the training course and will also be sent electronically after the course to the participants and their direct supervisors. The completed assessment form, signed by the participant’s supervisor, must be faxed to the training officer.
 
Course Duration: 3 Days
CEU: Pending