FDA guidelines for Bioanalytical Method Development and Validation - Recorded Webinar

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Venkata Kashyap Yellepeddi

The current webinar provides intensive training on details related to the bioanalytical method development and validation for drugs and nutraceuticals outlined in FDA's guidance. The webinar will help sponsors and analysts representing industries who are involved in filing investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements in developing bioanalytical method validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies that require pharmacokinetic (PK) or biomarker concentration evaluation.

The webinar is also helpful for training analysts involved in bioanalytical methods used for nonclinical pharmacology/toxicology studies. For analysts involved in veterinary drug approval process (Investigational New Animal Drug Applications (INADs), New Animal Drug Applications (NADAs), and Abbreviated New Animal Drug Applications (ANADAs)), this guidance may apply to blood and urine BA, BE, and PK studies. The webinar provides training on bioanalytical method development and validation with real-time data and experiments. The webinar will be delivered in two modules. In Module I, attendees will be introduced to various bioanalytical techniques such as liquid chromatography, mass spectrometry, ELISA etc. Currently used in pharmaceutical and veterinary industry.

Module I will also introduce attendees to the concept of validation and will provide general recommendations for bioanalytical method validation. Specifically, fundamental validation parameters such as Accuracy, Precision, Selectivity, Sensitivity, Reproducibility, and Stability will be discussed. In Module II attendees will be provided with a real-time example of validation. The module will also emphasize on documentation, statistics, and definitions of various terms outlined in FDA's guidance document of bioanalytical method validation.

Why should you Attend: Discrepancies in data integrity are one of the major reasons for FDA's penalization of pharmaceutical manufacturing facility. As analytical methods for drug quantification are widely used in many stages of drug development process, it is crucial for scientists, technicians, and quality assurance personnel etc. to understand the complete validation process of the analytical method. Specifically, when dealing with quantitative analysis of drugs in various biological matrices such as blood, serum, plasma, cerebrospinal fluid, urine, tissues, etc. validation of the method plays a key role. Unfortunately, many important aspects of validation outlined in FDA's guidance are often ignored and companies receive citations from FDA for these reasons. These citations may not only delay the process of drug development but also can jeopardize the future of the drug's regulatory acceptance.

If you are involved in quantification of drug using an analytical method in any stage of the drug development it is expected that you are well-versed with FDA's guidance for bioanalytical method validation. During routine inspections by FDA, inspectors often ask questions on analytical method validation and expect all personnel involved to be knowledgeable about the process of validation.

Areas Covered in the Session:
- Chromatographic Methods
- Ligand Binding Assays
- Parameters involved in Bioanalytical Method Validation
- Data Analysis, Statistics and Reporting
- Additional issues in Bioanalytical method Validation

Who Will Benefit:
- Chromatographers
- Analysts
- Chemists
- Scientists
- Formulators
- Patent Lawyers
- Technicians in Pharmaceutical and Veterinary Industry
- Contract Research Representatives

Venkata Kashyap Yellepeddi B.Pharm., Ph.D., is Assistant Professor of Pharmaceutical Sciences, College of Pharmacy, Roseman University of Health Sciences, Utah and Adjunct Assistant Professor, Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, University of Utah, Utah. Kash has 12 years of experience in teaching pharmaceutical compounding and pharmaceutics to students at bachelors, masters, and doctoral levels. Kash also works as a consultant for Isomeric Pharmacy Solutions, Salt Lake City, Utah, USA (a 503 B outsourcing compounding pharmacy) and Smith-Rexall Drug Company, Pleasant Grove, Utah, USA ( a 503 A compounding pharmacy). Kash’s research interest in compounding involves stability analysis and beyond-use-dating of extemporaneously compounded preparations.

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