Veterinary Medicine FY2009

ORAU State Training Classroom Course Schedule 
FY09 & FY10
VETINERARY MEDICINE

 

VM201- 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.

Objectives: Upon completion of this course, participants will be able to:

• • Identify appropriate investigative and data gathering techniques for conducting on-farm investigations of violative tissue residues.
  • Identify the documentation required for the development of a successful enforcement action.
  • 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

Prerequisite: N/A

• • CEU Credits:Pending
  • Course duration: 4 Days
  • Enrollment is limited to 40

Dates	Location	Registration Contact	FDA/ORA Trainer
TBD	TBD		Barbara James 240-485-6458 Barbara.James@fda.hhs.gov

 

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VM205 - Residue Violation Inspection System (RVIS)

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.

Objectives: At the completion of the course, students will be able to:

• • Access Food Safety and Inspection Service-reported violator information from the Residue Violation Information System
  • Identify patterns of egregious violations
  • Add Federal/State inspectional information

Target Audience: Residue Program Monitors and their designated back-ups.

Prerequisite: N/A

• • CEU Credits: Pending
  • Course duration: 3 Days

Dates	Location	Registration Contact	FDA/ORA Trainer
TBD	TBD		Barbara James 240-485-6458 Barbara.James@fda.hhs.gov

 

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VM206 - Medicated Feed Inspection

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

Objectives: Upon completion of this course, participants will be able to:

• • • Differentiate between the regulations that apply to FDA-licensed medicated feed mills and those regulations that apply to unlicensed feed mills.
    • Determine when drug assays are required.
    • Develop the knowledge of record-keeping requirements that apply to medicated feed mills.
    • Identify recent developments in the medicated feed arena.

Target Audience: Federal, state and local regulators conducting inspections of medicated feeds

Prerequisite: Participants should be actively involved in at least “basic/non-medicated” feed mill inspections

• • • CEU Credits: Pending
    • Course Duration: 3 days
    • Enrollment is limited to 40

Dates	Location	Registration Contact	FDA/ORA Trainer
10/21-23/08	Minneapolis, MN		Barbara James 240-485-6458 Barbara.James@fda.hhs.gov
11/06/08	Irvine, CA		Barbara James 240-485-6458 Barbara.James@fda.hhs.gov

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VM207 - AMDUCA/Compounding Animal Drugs

Course description:This course is intended to instruct field investigators on the laws, regulations and policies pertaining to compounding of animal drugs and the Animal Drug Use Clarification Act related to the extra-label drug use in animals.

Compounding of animal drugs has increased exponentially in the last few years. Certain compounding practices undermine the animal drug approval process, and present unknown and potentially hazardous risk to animal and human health. Animal drug compounding is addressed in various laws, regulations, and policies. In order to adequately assess violations of concern, investigators need to understand the laws, regulations and policy that distinguish animal from human drug compounding.

Extra-label drug use practices may especially result in violative food animal tissue residues.  Investigators need to understand under what circumstances extra-label drug use can or cannot be utilized in veterinary medicine.

Objectives: Upon completion of this course, participants will be able to:

• • 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.
  • Recognize appropriate investigative and data gathering techniques for conducting investigations of compounding pharmacies, veterinarians and food animal producers.
  • 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.

Prerequisite: Participants should have previous experience on inspections involving animal drugs.

• • CEU Credits: 1.9 
  • Course duration:3 days

Dates	Location	Registration Contact	FDA/ORA Trainer
TBD	TBD		Barbara James 240-485-6458 Barbara.James@fda.hhs.gov

 

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VM212 - BSE Feed Establishment Audit

Course Description: This course will provide background information and a historical perspective of the state contract auditing process for BSE and/or Medicated Feed Mill inspections. Classes will 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, participants will be able to:

• • • Identify procedures that are followed to conduct efficient and meaningful audits of State inspectors and/or a program audit under FDA’s BSE/Medicated Feed Mill contracts. 
    • Apply audit principles to identify and assess areas for improvement observed during the state contract inspection. 
    • Define the responsibilities and roles of both the auditor and the auditee.

Target Audience: FDA co-project officers, Consumer Safety Officers (i.e. investigators), and/or state personnel who will have the lead in auditing state inspectors and/or the program under state BSE/Medicated Feed Mill inspection contracts. Courses are scheduled by their primary audience as related to the audit: state personnel or FDA personnel.

FDA Consumer Safety Officers, who routinely work with FDA’s state BSE/Medicated Feed Mill contract audit program should attend the course held in Rockville, MD.

Prerequisite: N/A

• • • CEU Credits: Pending
    • Course Duration:  2.5 days

Dates	Location	Registration Contact	FDA/ORA Trainer
TBD	TBD		Barbara James 240-485-6458 Barbara.James@fda.hhs.gov

 

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VM213 - BSE Inspection Training

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 uniformly fatal neurological diseases known as Transmissible Spongiform Encephalopathies (TSEs).   BSE appears to be spread through the feeding of infected material to cattle.  BSE is a public health issue for the U.S.  This disease 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 is designed to prevent the establishment and amplification of BSE through animal feed, by prohibiting the use of certain proteins derived from mammalian tissue in the feeding of ruminant animals.  This regulation 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.  Based on the acute need to control the entry and spread of this disease, the Agency has set a goal of full compliance with the regulation.

Objectives: Upon completion of this course, participants will be able to:

1. Recognize  the inspection basics of Compliance Program Guidance 7371.009, “BSE/Ruminant Feed Ban Inspections” relating to:
   1. prohibited materials not to be used in ruminant feeds
   2. definitions of renderer/transporter/distributor/feed manufacturer and ruminant feeder.
   3. major inspectional questions to ask. Does the firm:
      1. receive / process prohibited material?
      2. handle prohibited material?
      3. label feed with prohibited material with proper cautionary statements?
      4. conduct the required recordkeeping?
      5. 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 should have previous experience on conducting inspections under the ruminant feed ban regulation.

• • • CEU Credits:0.7
    • Course duration: 1 day
    • Enrollment is limited to 40

Dates	Location	Registration Contact	FDA/ORA Trainer
TBD	TBD		Barbara James 240-485-6458 Barbara.James@fda.hhs.gov

 

 

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