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 webinar will review target areas addressed by FDA and EMA current guidance documents and ICH requirements. Current interpretation of guidance documents including failed runs, single stocks for standards and controls. Will address requirements for LC-MS, ligand binding and suggest requirements for cell based assays.
This Webinar will provide a review of current guidance documents for bioanalytical method validation to establish methods for the analysis of active pharmaceutical ingredients, metabolites and carrier components in biological materials. Recent 483s covering stability, single stock use and reporting of failed results will be discussed in detail, and approaches to avoid 483s will be presented. Web References to documents will be provided.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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