Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance

Website http://c2gowebinars.com/product/?topic=fda-draft-guidance | Edit Freely

Category Biotechnology , Pharmaceutical

Deadline: January 28, 2016 | Date: January 28, 2016

Venue/Country: Online, U.S.A

Updated: 2016-01-13 16:57:03 (GMT+9)

Call For Papers - CFP

The Bioanalytical Method Validation (Draft Guidance 2013) represents the Food

and Drug Administration’s current thinking on this topic and was published in September 2013. Since then, almost all regulated bioanalytical methods have been validated based on this guidance.

This guidance provides assistance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements in developing bioanalytical method validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies requiring pharmacokinetic (PK) evaluation.

This guidance also applies to bioanalytical methods used for non-human pharmacology/toxicology studies and preclinical studies.

This webinar will focus on the bioanalytical method validation to quantify drugs in biological matrices using LC/MS/MS.

Why should you attend :

"Bioanalytical method validation includes various procedures which demonstrate that a particular analytical method used for quantitative measurement of analytes in a given biological matrix (such as urine, plasma, blood or serum) is reliable and reproducible for its intended use. It is essential to develop robust, fully validated bioanalytical methods so that results can be interpreted with the utmost confidence.

This webinar will focus on the implementation of best practices described in Bioanalytical Method Validation (2013 Draft Guidance) and their subsequent use to support routine analysis of clinical and non clinical samples."

Areas Covered in the Session:

FDA guidelines for bioanalytical method validation.

Learning from the Crystal City FDA/Industry conference report.

Logistics of validation.

Development of a master plan and SOP for validation.

Preparation and use of reference standards and equipment.

Defining parameters and acceptance limits.

Defining validation experiments.

Considerations for Microbiological and Ligand-binding Assays.

To revalidate or not after method changes

Transferring and using the method for routine analysis.

Who will benefit: (Titles)

Managers and analysts in bioanalytical laboratories

QA managers and personnel

Validation specialists

Consultants, scientists, technologists, and engineers in the pharmaceutical industry.

Bioanalytical scientists

Biotech R&D staff

Outsourcing Professionals

Biopharmaceutical Consultants

Webinar Includes:

Free Bioanalytical Method Validation (Draft Guidance 2013); Crystal City V Conference Report.

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of Attendance