This training on bio-analytical methods validation will help you understand the clear, consistent and compliant approaches for instrumental, ligand binding, and cell based methods. A comparison of EMEA and FDA guidances will be presented.
This presentation will examine and discuss recent changes in the FDA and EMA Bioanalytical Method Validation guidance, how they have changed, what features have been omitted but may still be relevant. Cautious guidance in observance of these documents to ensure successful method validation and compliance. For example, there is no description of system suitability, yet this is a given in assuring that the analytical system whether it is instrumental, ligand binding or cell based is performing within acceptance on each day of use before the validation experiment is run.
The attendee will learn what parameters are important and expected for instrumental techniques and what parameters may be applied to ligand binding and cell-based assays. Additionally, the attendee will learn about common pitfalls in method validation and how to reduce the risk and avoid them. This would include ensuring sufficient resources and time to meet validation requirements as well as to examine where quality by design may be implemented.Areas Covered in the Webinar:
Individual Consultant, HJJ
Dr. Edward O’Connor has varied and extensive experience within both experimental and CLIA, GLP, GCP and GMP regulated laboratories. Dr. O’Connor is an recognized expert in both instrumental (LC-MS, LC-EC, LC-PDA) and ligand binding (MSD, ELISA, FLOW) and cell based assays. Molecules include small molecules, peptides, proteins, antibodies, aptamers and both DNA and RNA nucleotides. Dr. O’Connor is also experienced in allometric pharmacokinetics, and the design of in vivo and in vitro bioanalytical assays to reveal mechanism of action, efficacy and toxicity as related to animal and human studies for developing and evaluating pharmaceutical products. Dr. O’Connor uses and teaches the use of in silico techniques and programs (ACD, BLAST, etc.) in the design of both ligand binding assays and LC-MS approaches to accelerate the development of capture and detect moieties as well as chromatographic and mass spectrographic conditions to optimize assay performance.
Dr. O’Connor is a member of the emerging technologies and real time analysis committees of AAPS and has published in peer-reviewed journals and given numerous national and international presentations on the subject. Dr. O’Connor has also streamlined vendor selection and management processes, as well as implemented “DOWNTIME” practices to improve efficiency in Bioanalytical labs. Another facet is Dr. O’Connor’s application of statistics to predict cut points (receiver operator curve-ROC) for cell based and neutralization assays.
Dr. O’Connor has been working as an independent consultant in bioanalysis since 2017. A detailed description of his expertise and the services he provides may be obtained from the website www.aegisbioconsult.com.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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