Pacific Rim Consulting, Inc. - NEWSLETTER

Volume 11 Issue 2 - Summer 2008

Page 1 - Page 2 - Page 3

OECD Harmonization Workshop, Frascati, Italy

I recently had the pleasure of representing FDA at the OECD Harmonization workshop held in Frascati, Italy this past April. There were 230 participants from 33 countries (30 member countries and three non-member countries). Although the primary purpose of the workshop was to focus on global harmonization, it became more and more apparent that harmonization will never be reached. Not only are the GLPs difficult to harmonize between member countries, but the regulatory requirements vary dramatically. For example, the US EPA requires the Sponsor sign a compliance statement, while some countries forbid the Sponsor signature on a final report. It also became apparent that different interpretations of what the OECD GLPs actually require exist between the various countries. For example, although OECD GLPs allow for process based inspections for short term studies, there does not appear to be any agreement on what a “short term” study is. Some countries still allow the definition of raw data to be a paper print out of an electronic record, and still others have no definitive time that documents must be placed in the archives. During the previous consensus workshops, when there was disagreement between participants, the subject area was left very vague in order to obtain consensus. This has led to the individual monitoring authority interpreting the GLPs their own way, which actually results in much less harmonization.

  • A recommendation to allow “process based audits” for final reports for short term studies. In other words, QA would not audit each report.
  • Fragmenting a multi-site study into several “mono-site” studies (evidently this is allowable in some OECD countries).
  • The movement for GLP “certification” to move closer and closer to an ISO type certification, with increasing focus on facilities and not data integrity and studies.
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, 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)

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
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