The
Quality Assurance Unit (QAU) at STILLMEADOW, Inc. assures regulatory
compliance by auditing studies, reviewing protocols and all Standard
Operating Procedures (SOPs), advising study directors, and interacting
with sponsors.
The
QAU conducts regulatory training classes and hosts regulatory and
sponsor inspections, and assess subcontractor compliance. To keep
abreast of changing regulations and compliance issues, the QAU attends
yearly training and communicates with regulatory agencies, professional
organizations, and sponsors.
The
Quality Assurance Unit carries out report and data audits, facility
inspections, and in-process inspections for compliance with the
following:
- Good
Laboratory Practices (EPA, FDA, OECD, and Japanese MAFF)
- National
Pollutant Discharge Elimination System (NPDES) under the Clean
Water Act
- Texas
Pollutant Discharge Elimination System (TPDES)
- Resource
Conservation and Recovery Act (RCRA)
- Toxic
Substances Control Act (TSCA)
- Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA)
- International
regulations for EU, OSPAR, etc.
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