Pacific Rim Consulting, Inc. - NEWSLETTER
Volume 14 Issue 1 - Page 3 - Spring 2011
TIDS AND BITS - Continued |
FDA is considering all data relevant to FDA-regulated research conducted at the Houston facility from April 1, 2005 to June 15, 2010 unreliable based on the following reasons:
- The widespread falsification of dates and times in
laboratory records for subject sample extractions
- The apparent manipulation of equilibration or
“prep” run samples to meet pre-determined
acceptance criteria
- The lack of documentation regarding “prep” runs
that prevented you from conducting an adequate
internal investigation to determine the extent and
impact of these violations
The independent third party investigation shared FDA’s concerns, and stated the following with respect to the general impact on data reliability:
“[C]hromatography may have been acceptable, QCs may have passed and ISR [Incurred Sample Reanalysis] data (recent) may be very good, but doubt remains regarding the integrity of the basic elements of the analytical process due to the documentation irregularities. If the foundation of the laboratory is corrupt, then the data generated will be also. The investigation has uncovered practices that are clearly unacceptable. The major concern is the impact they may have had on the data generated. It is not possible to know the extent of the improprieties or their ultimate impact.”
A column from Pharmalot shortly after the letter was released titled “Reevaluating Studies: A CRO & A Coincidence?” revealed that there are several high level employees at Cetero that were employed at MDS when MDS was cited by FDA for similar violations.
Many Sponsors do not conduct rigorous QA inspections and reviews of clinical data, as there is technically no regulatory requirement for QA as defined for GLP. Maybe it is time FDA require a certain amount of independent QA oversight for clinical studies.
Those of you receiving the paper copy of this newsletter will not be receiving the documents mentioned earlier. However, they will be available on my website.
|
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 1400 pages (now on a handy CD!) 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)
|
One Day Seminars
- GLPs 101 (an Introduction)
- GLP Essentials for Technical Staff
- SOPs 101
Two Day Seminars
- QA Audits, Inspections and Responsibilities
- GLPs – Black, White and Gray
- GLPs for Scientists and Technical Staff
- Application of GLPs to Field Studies
- GCPs/GLPs in Target Animal Studies
- GLPs in Medical Devices
- GLPs for Study Directors and Monitors
- Establishing Effective GLP Systems
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 |