Pacific Rim Consulting, Inc. - NEWSLETTER
Volume 13 Issue 1 - Page 3 - Winter/Spring 2010
VETERINARIAN TREATMENT RECORDS |
The role of the staff veterinarian in relationship to the study director has been debated for many years. Veterinarians are charged with assuring facilities comply with the animal welfare act and that animals are treated humanely. Therefore, some feel that the veterinarians should “call the shots” regarding veterinary treatments of animals on study. Although this is most definitely the case in basic or academic research, veterinarians involved in regulatory research (GLP, animal rule studies, and animal health GCPs) are fulfilling a regulatory legislative requirement. EPA and FDA both require certain animal studies to be conducted in order to prove the safety (or lack thereof) of a compound prior to being marketed commercially. In the FDA world, most of these are studies are used to assess whether or not a test article is safe enough to be tested in humans. GLPs specifically require the following:
(c) At the initiation of a nonclinical laboratory study, animals shall be free of any disease or condition that might interfere with the purpose or conduct of the study. If, during the course of the study, the animals contract such a disease or condition, the diseased animals shall be isolated, if necessary. These animals may be treated for disease or signs of disease provided that such treatment does not interfere with the study. The diagnosis, authorizations of treatment, description of treatment, and each date of treatment shall be documented and shall be retained.
Therefore, all veterinary treatments should be authorized by the Study Director to assure they do not interfere with the purpose of the study, or mask a potential safety issue. Many times Study Directors would like to take an additional blood sample or measurement prior to treating, euthanizing, or removing an animal from study. Such information could prove invaluable during a safety assessment. Veterinary treatments (as indicated above) should meet all GLP requirements and be retained as part of the study file. These records are vital for a reviewer to assess the impact of treatment on the study objectives and outcomes. In the case where animals are reused, photocopies could easily be placed in the animals’ individual file. As a final note, some reviewers within CDRH have indicated that veterinarians should write contributing scientist’s reports. These reports could be valuable for all types of studies.
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WCQTI provides a practical, scientific approach to Good Laboratory Practice Regulations, focusing on industry standards and common sense as well as the written code. Training materials are over 500 pages (double sided) and include numerous forms, SOPs, reference articles, and other material critical to interpreting the intent of the regulations. Courses are structured to be highly interactive, providing opportunities for workshops and discussions. Every effort is made to present subjects in an informative, energetic manner. Additional experts in their particular field are brought in periodically for certain courses. |
ABOUT THE DIRECTOR |
Ms. Deborah Eyer Garvin, Director of the West Coast Quality Training Institute earned her MS in Agriculture from New Mexico State University. Ms. Garvin is also President of Pacific Rim Consulting, a Quality Assurance firm specializing in consulting and auditing for FDA, EPA and OECD GLPs as well as FDA GCPs for Target Animal studies. She provides contract QA services and training to Sponsor Companies, Project Management groups, Contract Laboratories, Universities, Teaching Hospitals, and individual test sites. Coming from a contract laboratory background, Ms. Garvin has implemented GLP compliance programs at several facilities, and understands the practical aspects of GLP compliance and adherence. Constant involvement in auditing and inspecting provides unique insights regarding current problems and issues, as well as cost-effective means of compliance. Numerous professional organizations have utilized her expertise as a consultant and invited speaker. Active in the Society of Quality Assurance, Debi is a Past President of the National organization, past chair of the SQA Registration Examination Committee, and was an original member of the Professional Certification Committee. She represented the Society of Quality Assurance at the OECD workshop held in the UK regarding multi-site studies, represented the FDA at the 2008 OECD GLP Harmonization workshop, and serves on the editorial board of the QA Journal. She is also a member of the SQA FDA Modernization of GLPs task force.
Seminars offered by WCQTI
(not all seminars are offered every year, but all are offered for in-house training)
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One Day Seminars
- GLPs 101 (an Introduction)
- GLP Essentials for Technical Staff
- SOPs 101
Two Day Seminars
- QA Audits, Inspections and Responsibilities
- GLPs in the Real World
- GLPs for Scientists and Technical Staff
- Application of GLPs to Field Studies
- GCPs/GLPs in Target Animal Studies
- GLPs in Medical Devices
- Application of GLPs in the Bioanalytical Lab
- GLPs for Study Directors and Monitors
ON SITE TRAININGAny seminar or combination of seminars can be customized to meet your company’s needs, and provided on site or at your choice of venues. Fees are invoiced at a flat rate with no “add-ons” or “per-person” charge. Call Debi at (541) 352-7120 for more information or email debi@pacrimqa.com |