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Bioanalytical Specialty Section

Bioanalytical Specialty Section (BASS) serves as a network resource for QA professionals addressing regulatory compliance questions as applied to GXP bioanalytical testing.  BASS strives to define a standardization of common systems in the industry and works in cooperation with regulatory authorities to assure alignment with the intent of the regulations.  BASS will provide relevant regulatory-based training in the area of bioanalytical testing.
 

Mission

  • Resource:  Serve as a member resource for bioanalytical testing for interpretation and application of current regulatory trends
  • Network:  Maintain a network of resources to address issues specific to our members and cooperatively work towards standardization of common practices
  • Liaison:  Work in cooperation with the regulatory authorities to assure that laboratory operations are in alignment with the intent of the regulations, pose questions for interpretation as they arise from the group and seek guidance on pertinent issues
  • Train:  Provide relevant regulatory-based training in the area of bioanalytical testing.
  • Communicate:  Communicate to SQA the activities and progress of BASS via an updated website, workshops, liaisons to other SQA groups, articles and presentations

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