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Establishment of GLP Programs
QAI has established and implemented over 40 GLP programs. Clients include
- Research and discovery units requiring to conduct specific regulatory studies
- Start-up companies specializing in safety or environmental studies
- Growing companies deciding to conduct work in house instead of contracting all work to CROs
- New laboratory units of larger companies requiring an individual GLP structure
Tasks included:
- Develop an implementation plan with management
- Develop and customize an entire SOP manual
- Conduct GLP training of all study personnel
- Develop customized documentation forms
- Assist management and QAU during the implementation
- Assist client during FDA or EPA GLP inspection
_Case study
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