ComplianceOnline, OnlineEvent
2012-08-02
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. 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.
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Invited Speakers:
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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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