ComplianceOnline, Online Webinar
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.
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
||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.