Pacific Rim Consulting, Inc. - NEWSLETTER
Volume 11 Issue 2 - Page 3 - Summer 2008
RECENT WARNING LETTERS and IDEAS |
There are two new warning letters available on the FDA webpage. The Washington Biotechnology warning letter was issued in February while the Sitek Research Laboratories is dated in May. Several Sponsors also informed me that BioRelliance had received a warning letter on January 5, 2009, but it is not posted on the web. The observations found in the Sitek and Washington Biotechnology warning letters are appalling and indicate a complete lack of understanding of the GLP Regulations. Virtually every violation that is possible is identified in the Washington Biotechnology letter, while Sitek has numerous repeat violations from the prior warning letter. Based on the severity of these violations, other issues described in 483’s, and the trend to outsource studies outside of the United States, perhaps it is time to start requiring some type of registration process for all entities wanting to conduct GLP studies (or portions thereof). This registration would assure that only facilities who understand GLPs and have established GLP systems are able to submit data to FDA. Unlike the OECD process, no certificate would be issued, no site visits conducted, and no declaration of GLP compliance given. The registration would be granted simply based on a review of critical GLP documents by FDA, and be an allowance for these facilities to conduct GLP studies. I would envision that all facilities which have been successfully inspected by FDA would be automatically registered. The FDA BIMO program would continue to focus on the most important aspect of GLPs, data integrity and simply use the registration to weed out those facilities that “don’t get it”. A registration system could also help ease concerns of Study Directors at CROs when the Sponsor is outsourcing portions of a study or conducting assays at their own facility. It also appears that it is time for the FDA disqualification process be streamlined. With limited resources and personnel, FDA should not keep accepting data from non-compliant facilities. High quality, reliable non-clinical safety data is crucial prior to allowing devices/drugs to be used in humans.
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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.
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 |