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
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)
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