1966 B.S., Chemistry, Brigham Young University, Provo, Utah
1969 M.S., Microbiology, Brigham Young University, Provo, Utah
1975 Ph.D., Medicinal Chemistry, University of Utah, Salt Lake City, Utah
2003 – Present Principal, Regulatory Compliance Initiatives, Inc.
Filing of electronic INDs, NDAs, ANDAs and DMFs in eCTD format
Assembly and review of Chemistry, Manufacturing and Controls documents for INDs, NDAs and ANDAs
Assembly and review of DMFs
Audits/Preparation for Preapproval Inspections
Consent Decrees and CAPA Initiatives
All aspects of Quality Assurance/Quality Control including instituting Quality Systems and Quality Policies.
Analytical work/validations including establishing an Analytical/QC function
Bioanalytical work/validations including auditing and preparing a bioanalytical laboratory for an FDA inspection.
Due Diligence Audits
1994 – Present Principal, Omega Pharmaceutical Consulting, Inc.
Consultant to the pharmaceutical industry in the areas listed for RCI
1991 - 1994 Boehringer Mannheim Pharmaceuticals – Now part of Roche
Responsible for all aspects of Product Development and Quality Assurance including interaction with international affiliates and contract manufacturers. Built out and staffed analytical laboratories including all aspects of Quality Control. Established the QA function including SOP’s and all associated systems. Staff of 14.
1989 - 1991 Janssen Research Foundation, Titusville, NJ 08560, Director, Product Development
Responsible for assembly and review of numerous INDs and NDAs. Functional areas included analytical laboratories, bioanalytical laboratories and formulation development. Staff of 20.