Clinical and Bioanalytical laboratory Audits

One of the critical tasks for a Good Laboratory Practices (GLP) nonclinical laboratory study or Clinical Trial team is choosing a bioanalytical laboratory vendor that will meet their study needs. A well-managed bioanalytical study with proper Sponsor oversight will go a long way to ensure the generation of accurate data and quality data. Many companies have a Research & Development Quality Unit that includes people with auditing skills in Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs). Many R&D auditors have a background in what is required to audit a bioanalytical laboratory for either Clinical trials, GLP, GLP-Like or best laboratory practices. Bioanalytical Laboratory Vendor Qualification Audits.

  • Sample Handling, Sample Chain of Custody
  • Method Validation
  • Computer System Management
  • GDP and GLP compliance
  • Operating procedures and protocol compliance
  • Clinical Affairs & Regulatory Strategies

Related Conference of Clinical and Bioanalytical laboratory Audits

November 09-11, 2017

4th European Biopharma Congress

Vienna, Austria
August 20-22, 2018

9th Asian Biologics and Biosimilars Congress

Tokyo, Japan

Clinical and Bioanalytical laboratory Audits Conference Speakers

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