Renee Daniel Email and Phone Number

Consulting firm specializing in assessment, design and implementation of processes including GLP and Biotech (USDA-APHIS) Inspections programs. Services also include training seminars in GLP and APHIS regulations. Primary contracts include conduct of critical phase inspections, data/report audits, GLP and APHIS compliance assessments, development of GLP compliance programs and training GLP personnel. Long-term contracts also include QC of pesticide labels and EPA submissions for accuracy and compliance as well as US and International regulatory consulting.Approved and trained by USDA-APHIS-BRS as 3rd party inspector/auditor for two special projects.Biotech Inspection Program Manager since 2005 - Responsibility for assigning sites and managing up to 15 professionals in scheduling, conduct, and reporting of inspections for USDA-APHIS regulated field trials for two multi-national companies. Contracted responsibility includes conducting inspections as well as assuring that other professionals are adequately fulfilling their contracted responsibilities. Qualified Auditor for BIO ETS Program and Approved Third-Party Auditor for USDA APHIS BQMS Program. Qualified to conduct joint audits covering both programs. Regulatory experience includes EPA, FDA, and OECD GLPs and USDA APHIS regulations. Areas of expertise include lab, field, worker exposure, environmental fate, toxicology, target animal studies, and biotechnology (genetically engineered crops).

Fulfill all responsibilities related to Quality Assurance Unit (QAU) management, train and supervise QAU staff. Assure that off-site facilities are GLP compliant and that QA is adequately conducted and reported (approx. 50 field cooperator and external laboratory sites). Types of studies include project management, FDA non-target, worker exposure, environmental fate, metabolism and residue. Conduct GLP training for Pan-Ag staff. Active participant in one EPA audit which included inspectors from the Netherlands, as well as David Dull and Francisca Liem.

Responsible for evaluation of facilities, laboratory practices, documentation and study conduct to assure both management and EPA that studies were being conducted in accordance with all government regulations and results accurately reported. Types of studies included metabolism, residue, environmental fate, toxicology and product chemistry, both in-house and contracted (field and laboratory). Active participant in two EPA audits.

Contracted to fulfill the responsibilities of Quality Assurance Manager. Organized QA program and generated written QA SOPs. Refined GLP program to facilitate enforcement and compliance. Conducted GLP training to assure that QA and scientific staff were knowledgeable of current government regulations. Responsible for fulfilling all EPA GLP requirements related to the QAU. Acted as a regulatory advisor for various types of studies.

Designed and implemented QA/GLP program. Responsible for evaluation of facilities, lab practices, documentation and study conduct to assure management and EPA that studies were conducted in accordance with all government regulations and results accurately reported. Types of studies included residue, metabolism and environmental fate, both in-house and contracted (field and lab). Other responsibilities included supervision of QA personnel and generation of written reports and communications. Actively participated in two EPA audits.

Conducted pesticide residue, metabolism and environmental fate studies. Responsibilities included direction of research studies from lab initiation through preparation of final report for EPA submission and supervision of scientific staff. Acted as Study Director, wrote final EPA submission reports.