Ensuring Compliance Of Your Bioanalytical Method Validation With The 2013 FDA Draft Guidance
Duration : 75 Minutes
Brian Kirk,
Brian A. Kirk, Ph.D. has been employed in both the biotech and pharmaceutical industries for over 20 years. He has a wealth of experience, working in the areas of synthetic organic, polymer, combinatorial and medicinal chemistries. He spearheaded the drug discovery efforts for multiple clinical candidates and successfully facili Read more
The Bioanalytical Method Validation (Draft Guidance 2013) represents the Food and Drug Administration’s current thinking on this topic and was published in September 2013.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 (
Course Objectives:
• Understand the basic FDA guidelines for method validation described in the 2013 Draft GFI Document.
• Understand the significance of a bioanalytical method validation and its applicability to different aspects of drug development.
• Understand how to interpret the Draft Guidance and use it to establish validation parameters and acceptance limits.
• Understand the difference between a full, partial and cross-validation.
• Know how to apply the bioanalytical method validation to testing for routine drug analysis situations.
• Understand the basics of how to draft an SOP describing the Bioanalytical Method Validation process.
Course Outline:
• 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 re-validate or not after method changes
• Transferring and using the method for routine analysis.
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
