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Deborah Eyer Garvin, MS, RQAP-GLP

Pacific Rim Consulting, Inc, provides third party EPA/FDA/OECD GLP and GCP (VICH) consulting services, which include evaluation of internal procedures, third party inspections and audits, facility evaluations, and internal training seminars. With over 20 years active GLP experience in both Contract Lab and Sponsor organizations, she offers a wide perspective regarding compliance. Additional consultants are hired to assist with larger projects upon approval by the client. Pacific Rim Consulting has provided in-house training and inspections/audits for Sponsors, Contract Laboratories, test sites and government agencies. Primary areas of GLP expertise include FDA Medical Device, Toxicology and Animal Health (GLP and GCP) studies along with EPA field, biotech, toxicology and efficacy studies.

CV for Deborah Eyer Garvin
EDUCATION:

M.S.  Animal Science-Emphasis on Genetics – New Mexico State University – July 1987

Thesis: Feedlot and Carcass Evaluation of  Two and Three Way Cross-bred Steers

B.S.   Agriculture Extension and Education – New Mexico State University – May 1985

B.S.   Agriculture-Animal Science – New Mexico State University – May 1975

 

TRAINING/EXPERIENCE:

Society of Quality Assurance, Annual Meetings – Orlando, FL 1990; Kansas City, KS  1991; Atlanta, GA  1992; San Francisco, CA 1993; New Orleans, LA 1994;  Phoenix, AZ 1995; Baltimore, MD, 1996; Seattle, WA 1997; Denver, CO 1998; Chicago, IL 1999; Montreal 2000; San Diego, CA 2001; Albuquerque 2002; Washington DC 2003; Reno, NV 2004; Orlando, FL 2005; Phoenix, AZ 2006; Austin, TX 2007, Memphis, TN 2008

Red Apple 2 (Computerized Systems in GLP studies) – DIA – Philadelphia, PA  March, 2006

OECD International Harmonization Workshop – member of FDA delegation, Frascati, Italy April 2008

Fourth OECD Workshop – Application of GLPs in the Organization and Planning of Multi-site studies – London, UK – SQA FDA Representative – June 2001

CROMERRR presentation/workshop – Washington DC July 2000

Pacific Regional Chapter SQA – Quarterly meetings from inception to present covering various topics

SQA Regulatory Review meetings – Quarterly meetings from 1993-present covering current issues and topics in the FDA and EPA arenas

Second OECD Consensus Workshop, Applications of GLP to Field Studies – Vail, Colorado – May 1991

(Represented the Society of Quality Assurance)

 

PROFESSIONAL EXPERIENCE:

Director – West Coast Quality Training Institute –  September 1993-present

Provide GLP training workshops throughout the United States for quality assurance personnel, study directors, scientific staff, technicians, analytical chemists and field trialists. Training is based on a scientific, practical approach to impleting EPA, FDA and OECD Good Laboratory Practice Standards for pre-clinical/non-clinical studies and Clinical guidelines for Target Animal Studies.

President – Pacific Rim Consulting,  May 1992-present

Work as a Good Laboratory Practice consultant and provide Quality Assurance oversight to various firms for compliance with EPA/FDA/OECD Good Laboratory Practice Regulations, specializing in toxicology, target animal, field, analytical chemistry, and metabolism studies. Conduct mock EPA/FDA, in-process and  facility inspections;  provide auditing services for protocols, raw data, draft and final reports, consult on various aspects of the Good Laboratory Practice Regulations and VICH GCP guidances.  Also provide in house as well as formalized training sessions for QA and scientific staff members.

Faculty member – PERI Institute – 2004-present   – provide training on behalf of the Pharmaceutical Education and Research Institute onm an “as needed” basis.

Quality Assurance Specialist/Senior Quality Assurance Officer – Pan-Ag Laboratories;  Sept 1989-May 1992

Primary responsibilities included development and implementation of the GLP compliance program, along with extensive client interactions, interpretation of government regulations and establishment of database systems for monitoring studies. Audited and inspected field trials and cooperators throughout the United States. Established the new analytical laboratory GLP compliance program.  Other responsibilities included auditing in-life phases as well as protocols and reports for all types of field, analytical, metabolism, and nontarget studies assuring conformance to government guidelines and GLPs.  Served for two years as the technical writing advisor, providing guidance and training to the scientific staff.

Areas of expertise: Field studies, analytical chemistry, non-target toxicology and plant metabolism.

Quality Assurance Specialist – ABC Laboratories, Columbia, MO – April 1988-August 1989

Duties included monitoring research studies, protocols, reports and facilities for regulatory compliance.  Also maintained and modified database systems for study, protocol and audit tracking.  Primary divisions of responsibilities were Pharmaceutical and Aquatic Toxicology.  Duties also required interaction and communication with government regulatory personnel, ABC professional and technical staff and representatives from major agriculture, chemical and pharmaceutical companies. Areas of expertise: Toxicology, analytical chemistry, pharmaceutical studies,  large animal studies

Quality Assurance Officer – Primate Research Institute, Alamogordo, NM – August 1986-April 1988  

Duties included monitoring and evaluating studies and protocols for FDA and EPA/GLP compliance as well as study design, statistical analysis and humane issues.  Maintained a database inclusive of all research studies conducted and test material used.  Responsible for archival and retrieval of all study reports and test material.  Areas of expertise:  Primate and small animal toxicology and metabolism.

Graduate Research Assistant – New Mexico State University, Las Cruces, NM;  August 1985-August 1986

Research responsibilities included conduct of research and evaluation of feedlot performance and carcass merit of crossbred steers, along with breaking and training Quarter Horses for muscle fiber research.  Collected, compiled and analyzed data using SAS.  Teaching assignments included horse production and population genetics classes.

 

PROFESSIONAL & SCIENTIFIC ORGANIZATIONS (MEMBERSHIP/ACTIVITIES):

SQA FDA Moderization of GLPs Task Force member 8/2007 – present

Society of Quality Assurance – President – 2001-2002

Registered Quality Assurance Professional – 1997 – present

GLP, Medical Device, Animal Health, Speciaty Sections  2001-present

Society of Quality Assurance – 1988 – Present

Society of Quality Assurance – Regulatory Forum 1992-present

Society of Quality Assurance – Registration Examination Committee,  1993-2005  Chair 1999-2001

Society of Quality Assurance – Education Committee, 1997-1999 (Chair 1998)

Society of Quality Assurance – Professional Certification Committee, 1993-1998

Society of Quality Assurance – Planning Committee – 1990-1993; 1995-2001

Pacific Regional Chapter SQA 1992-present; Founding President; President 1995; Board of Directors 1999-2001

PRESENTATIONS AND PUBLICATIONS:

Society of Quality Assurance – Advanced Training, presenter – San Diego, CA 2001, Seattle, WA 2003; Washington DC 2003; Reno, NV 2004; Orlando, FL 2005; Phoenix, AZ 2006; Austin, TX 2007

Society of Quality Assurance – Role of Quality Assurance in GLP and GCP studies – Austin, TX 2007

AALAS – District Meeting – San Diego, CA April  2007

Role of the Study Director in GLP– QA Journal – Sept 2006 Vol 10 No. 3

Guest Editorial – Data Quality – QA Journal – Volume 6 – 2002

OECD Consensus Document “Application of Good Laboratory Practice Standards to Multi-Site studies”, member of “Group of Experts” responsible for drafting the document.  Published and deregulated  – March  2002

NAICC – OECD Update – Orlando, FL – January 2001

Society of Quality Assurance National Meeting – Basic Training 1996, 1997, 1998, 1999, 2000, 2005, 2007

Society of Quality Assurance – Advanced Training, Auditing reports and data,  1999

Society of Quality Assurance National Meeting – “Effective Training” – Phoenix, AZ – October 1995

Society of Quality Assurance National Meeting – “Auditing Analytical Data”- New Orleans, LA – October 1994

NAICC – “Qualification/responsibilities of QA” – Memphis, TN – January 1994

NAICC Newsletter – “Qualifications and Responsibilities of Quality Assurance Professionals” – April 1993

Pacific Regional Chapter, SQA-“Facility Audits from a Consultant’s Viewpoint” – Richmond, CA – November  1992

SETAC – “Quality Assurance in a GLP Analytical Laboratory”,  Cincinnati, Ohio – November 1992

SQA – “Qualifications and Responsibilities of Quality Assurance Personnel”- Specialized Training presentation, Atlanta, GA  – October 1992

OECD Consensus Document “Application of Good Laboratory Practice Standards to Field Studies”, member of “Group of Experts” responsible for drafting the document.  Published and deregulated  – March  1992