New FDA Guidance on Bioanalytical Method Validation

Why Should You Attend:

The FDA issued the latest updated guidance on BMV in May 2018, after much anticipation following the release of the draft in 2013. It is now an authoritative document that the bioanalytical professionals need to incorporate into their standard operating procedures. The good news is that this document does not make drastic changes in the already available guidance from FDA and other global regulatory agencies, but provides a progression in the field due to advancements in science.

The guidance is equally applicable to chromatographic and ligand binding assays covering both the chemical and biological drugs. But to understand how you can apply the recommendations of this standard and avoid confusion on various standards related to same subject ( ex- EMA guidance) an in-depth understanding of these topics would be helpful.

Attend this webinar to understand the core principles, parameters and specifications for bioanalysis provided in the new FDA guidance for method development, validation and sample analysis using chromatographic and ligand binding technologies. The new additional topics on the analysis of endogenous compounds and biomarkers, learn in greater details the method development and report writing. The aim of the webinar is to provide a comprehensive understanding of the existing and new requirements.

Areas Covered in the Webinar:

• Core principles, parameters and specifications for bioanalysis provided in the new FDA guidance for method development, validation and sample analysis using chromatographic and ligand binding technologies
• Comparison of the new guidance with the first FDA guidance
• What remains unchanged
• What has changed
• New ideas and topics introduced in the new guidance
• Comparison of the new FDA guidance with the other major global guidance, e.g. from EMA
• Where the guidance have similarities
• Any major conflicts and how do we deal with them?

Who Will Benefit:

• Senior leadership and management teams overseeing the samples analysis for clinical and toxicology studies
• Bioanalytical professionals at all levels
• Quality assurance managers and auditors
• Regulatory Affairs managers
• CROs and consultants serving in the related fields

Surendra Bansal
Global Regulated Bioanalysis Consultant, Independent

Dr. Bansal is global consultant for regulated bioanalysis. His working experience in the field of bioanalysis has been both in the Pharmaceutical companies (recently at Roche for 20 years and previously at American Cyanamid for 5 years) and contract research organizations (combined 4 years in 2 organizations). During this period he has worked on both, small and large molecules bioanalysis; supporting studies from drug discovery to regulatory drug development and marketing. He has developed and validated numerous bioanalytical methods using various cutting edge technologies. In a span of over 25 years in bioanalysis, he developed strategies for enhancing technologies, gaining efficiency, quality and regulatory compliance in bioanalytical work. He is globally active in several bioanalytical organizations, e.g., as an executive member and past-chair of the AAPS Bioanalytical Focus Group, founding member of the Global Bioanalytical Consortium (GBC). He has given lectures at numerous international conferences and has chaired several symposia and conferences, including AAPS Crystal City III bioanalytical workshop, AAPS conference on analytical instrument qualification (AIQ) and APA regulated bioanalysis workshop. He has published over 65 articles, book chapters and abstracts in bioanalytical and related fields.

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