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Quality Assurance & Scientific Support
Establish GLP Programs
Third-Party GCP Auditors
Supporting Existing QAU
Scientific Support & SOP Development
Training Programs
21 CFR Part 11
GLP Archiving
 
 
 
 

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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