Good Laboratory Practices for Bioanalytical Laboratories - Webinar By ComplianceOnline (Laboratory Complianc)
Venue: Online Event
|Event Date/Time: Jun 21, 2012||End Date/Time: Jun 21, 2012|
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.