Good Laboratory Practices for Bioanalytical Laboratories

Why Should You Attend:

FDA does not currently have detailed regulations covering bioanalytical assays on samples from human clinical trials. To assure a minimum level of data quality, integrity, and accuracy, bioanalytical labs have adopted applicable portions of the GLP regulations. Understanding this, FDA has published several guidances in the past decade to address specific challenges in doing bioanalytical work according to GLP requirements. This presentation covers the current best practices for adapting GLPs to bioanalytical studies. It highlights specific examples where GLPs are not appropriate and emphasizes special situations in bioanalytical work where FDA's requirements are very strict, such as method and equipment validation and electronic data collection.

This presentation describes first the areas of bioanalysis that can be performed according to GLPs. The webinar also briefly reviews parts of the GLP regulations that do not apply to bioanalysis. The types of bioanalytical samples are reviewed so that attendees understand how their work falls into this special area of FDA regulation. Attendees will learn of the special focus areas of FDA inspectors, such as matrix interactions, drug-drug interactions, physiological factors in subjects, dosing regimen, and dietary factors. The presentation then covers the best practices and industry standards for handling bioanalytical samples. The discussion includes the following topics: sample coding; shipping and receiving; sample database; distribution logs; internal and external chain-of-custody; and archiving of retained samples. The webinar also reviews the other regulations that have become integral to analysis, sample handling, and data management. Within the discussion of bioanalytical activities that can be performed according to GLPs, the presenter discusses specific types of data output, such as chromatograms, and lists the minimum testing that analytical systems require for showing FDA that an instrument has been validated, calibrated, and tested for system suitability.

This webinar gives special attention to quality control in bioanalysis. In particular, the discussion covers how corrective and preventive action (CAPA) programs relate to bioanalytical work. Within this discussion is a brief overview of incurred sample reanalysis (ISR) and how ISRs are managed by most bioanalytical labs today. The presentation concludes with a flowchart for labs to use when self-auditing their processes, high-risk activities, and error trends. The presenter offers examples of FDA focus areas and warning letters that have been issued to bioanalytical labs. The final slide summarizes the main points and take-home messages. Overall, this overview should serve as a primer for new bioanalytical labs as well as established labs in considering all aspects of quality in their sample and data management systems.

Areas Covered in the Seminar:

• What are the bioanalytical assays adaptable to GLPs
• What are the types of bioanalytical samples
• What are test practices in sample management
• How to manage special considerations in bioanalytical samples for matrixes, interactions, stability, etc.
• What are the requirements for method and equipment validation
• How to manage and archive electronic bioanalytical data
• How to identify high-risk steps and establish corrective actions
• How to self-audit your bioanalytical process

Who Will Benefit:

This webinar is for all staff of bioanalytical laboratories involved in sample receipt, handling, analysis, and archiving, or validations, or reporting

• Contract bioanalytical labs
• Sponsor company bioanalytical departments
• Universities conducting bioanalytical work
• QA professionals
• Managers, lab managers, study directors, principal investigators, scientists, and information technologists
• Staff responsible for sample receipt and distribution
• Bioanalyical labs at CROs, sponsors, universities

Instructor Profile:

Anne Maczulak, PhD, RQAP-GLP, is an independent consultant at Acorn GLP Consulting. She has more than 20 years experience as sponsor, study director, or participating scientist in preclinical studies. Anne works with established companies, startups, and universities in need of guidance in GLP regulations. She has presented webinars for FDA and training courses for the Society of Quality Assurance. She audits laboratories that conduct nonclinical studies and/or bioanalysis and provides on-site as well as remote training in GLP.

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