FDA Compliance

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Follow the money and save: Making the business case for responsible chemical ...
By American Industrial Hygiene Assn.
White paper
This white paper by the American Industrial Hygienists Association (AIHA) discusses options for chemical management programs, including supply side total chemical management and compliance side total chemical management.

SOP management as a compliance tool in FDA and ISO environments
By MasterControl Inc.
White paper
This white paper by MasterControl discusses why Standard Operating Procedures (SOPs) are more than just a tool of operation, and how an effective SOP management system can support both sustainable compliance and long-term success in the market.

FDA Guidance for Industry: E15 Definitions for Genomic Biomarkers, ...
By FDA Center for Drug Evaluation and Research
White paper
This guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories.

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