Good Laboratory Practices for Bioanalytical Laboratories - Webinar By ComplianceOnline (Laboratory Complianc)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Jun 21, 2012 End Date/Time: Jun 21, 2012
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This 90-minute webinar will help you to develop a sound bioanalytical process to ensure quality data. It will cover techniques for bioanalytical data management for the purpose of assuring a regulatory agency that the data have been collected, managed, and archived to the highest standards of quality assurance. You will understand the aspects of bioanalysis that can be run according to GLPs and the aspects in which GLPs do not apply.

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.


Online Event
2600 E. Bayshore Road
Palo Alto
United States