Ensuring Compliance Of Your Bioanalytical Method Validation With The 2013 FDA Draft Guidance

Brian Kirk

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The Bioanalytical Method Validation (Draft Guidance 2013) represents the Food and Drug Administration’s current thinking on this topic and was published in September 2013.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.

Course Objective

  • 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  • Understand how to interpret the Draft Guidance and use it to establish validation parameters and acceptance limits.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

Topics covered include:

  • 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.


Target Audience

  • 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 

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Training CD-USB

Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment

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Recorded video

Recorded video session

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Speaker: 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 facilitated the tech transfer of the manufacturing processes from the bench into the pilot plant. He is highly knowledgeable in the areas of metabolic disease, oncology and cardiovascular disease, but has worked on numerous therapeutic targets during his tenure in industry. Brian began his career at Pharmacopeia, where he designed and synthesized combinatorial libraries for numerous large pharma clients. He then went to work in the medicinal chemistry department at Merck Research Laboratories, holding positions of increasing responsibility during his tenure there. While at Merck, Brian served on the project team that developed Januvia, a drug NDA-approved for treatment of type 2 diabetes. After Merck, he then made the jump to the biotech industry in Boston, working in the chemistry department at Surface Logix. There, Brian held positions of increasing responsibility, eventually providing oversight of many discovery research efforts as well as GMP manufacturing campaigns for several clinical candidates. Most recently, Brian has been working as an independent consultant, heavily involved in compliance auditing for bio analytical method validation and toxicology reports for small molecule clinical candidates.


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