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US EPA Office of Environmental Information
N&C
has played a lead role in the development of a Quality
Management System for OEI,
which provides a wide range of services in the areas
of information management and technology.
- Food and Drug Administration
N&C is developing a Quality System
for the Chemistry Manufacturing and Controls (CMC)
review process at FDA. The CMC review is a key step
in the evaluation and approval for manufacturing
of new drugs and biologics.
N&C developed the EPA Special Pathogens Analysis
Laboratory program plan for laboratory operations
and environmental analysis of bioterrorism
agents such as anthrax (Bacillus anthracis).
The program plan included a quality system and standard operating procedures
for sample
tracking,
sample analyses and general SPAL operations.
- Waste Management, Inc., and EPA
N&C oversees the quality assurance for a large-scale
technology evaluation of an alternative municipal landfill
operation. The project
includes a cooperative agreement between Waste Management,
Inc., and EPA.
We have played a lead role in the creation of several
EPA guidance documents, including the following:
- Guidance on Data
Quality Indicators;
- Guidance on Data Verification and Data Validation;
- Guidance
Document for Environmental
Technology Design, Construction, and Operation; and
- Guidance on Systematic Planning for Environmental
Data Collection Using Performance
and Acceptance Criteria.
We have also prepared and conducted training
workshops for national audiences on technical issues
related to environmental QA and statistics.
We have made training presentations at
EPA’s annual National Conference
on Managing Environmental Quality Systems and at EPA’s
annual Summer Training Workshop.
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