Pacific Rim Consulting, Inc. - NEWSLETTER
Volume 11 Issue 1 - Winter 2008
Recent findings from FDA 483's
The QAU failed to immediately bring to the attention of the study director and management any problems found during the course of an inspection which are likely to affect study integrity. Specifically, results of ______ Antigen assays conducted between the dates of 3/29/2005 and 5/4/2005 indicated the presence of test article in serum from vehicle treated animals. The QAU inspected the Antigen Assay Data on 9/22-23/2005. According to General Note to File dated March 30, 2007, the unexpected findings regarding test article in control animal samples were acknowledged by the Study Director on April 11, 2007, approximately 19 months from the date of the QAU inspection.
Not all documentation generated as a result of a nonclinical laboratory study were retained. Specifically, study correspondence in the form of emails and phone logs between study personnel and the Study Director were not retained in the study files for the following studies. Study 01-___ and Study 03-______.
The testing facility does not have written SOPs setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study.
Specifically, for Study 01-______ , the method described in ___SOP ____ [Analytical method] effective ______ was used for the determination of Cynomolgus monkey serum and amniotic fluid. However, the method described in the SOP was only validated for determination of _____ in human serum. Therefore, management had not determined that the method was adequate for measurement of _______ in Cynomolgus monkey serum and amniotic fluid.
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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. |
We now have EPA and FDA GLP booklets, complete with key words and the preambles available for sale. The cost is $6.00 each, which includes shipping and handling.
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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, and serves on the editorial board of the QA Journal. She is also a member of the SQA FDA Modernization of GLPs task force.
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Seminars
offered by WCQTI(not all seminars are offered every year) |
One day seminar
- GLPs 101 (an Introduction)
- GLP Essentials for Technical Staff
- SOPs 101
Two day seminars
- AQ 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
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ON
SITE TRAINING Any 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 |