Analytical Methods: What Makes Them “Suitable” Can Be Subtle

Drug Discovery and Development, Laboratory Technology, Life Sciences, Pharmaceutical, Pharmaceutical Regulation,
  • Tuesday, September 16, 2014

How to verify, validate, transfer, qualify or at least find suitable analytical methods.

In the last decade information from FDA, ICH, industry and other entities provided useful guidelines and insights into validation of analytical methodology. However, even with these and industry publications, details of validation parameters at different development phases are not explicit.

This presentation will visit current guidelines and also discuss subjects, such as, when should I study forced degradation? The presenter will also review early development to compendial procedures, and provide an overview of method transfer options.



Harley Everett Wilcox, Senior Scientific Advisor, ABC Laboratories

Harley Everett Wilcox brings 25 years of experience in drug research and development to ABC. Prior to joining our team, he served in various technical and management positions with both large and startup Pharmaceutical companies, including working as director of manufacturing responsible for CMC regulatory support and CRO/CMO outsourcing. Harley served as the global NDACMC submission leader for Anzemet®, and has supported numerous IND’s, CTA’s, and CTX’s as well as an ANDA. Having begun his career as an organic chemist, Harley’s expertise includes analytical methods development and validation, isolation and identification of impurities in drug products, and in-vitro metabolic characterization supporting pre-clinical research; he also has assisted many small and virtual Pharmaceutical companies with regulatory aspects of early CMC development programs, and has participated in collaborations, contracts, and intellectual property management in support of business development objectives. Harley is recipient of the Marion Laboratories presidential award for developing a high yield reclamation process for the active ingredient of a commercial formulation.

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Who Should Attend?

  • VP/Director/Manager of Research and Development
  • VP/Director/Manager of Product Development
  • VP/Director/Manager of CMC Operations
  • VP/Director/Manager of Technical Operations
  • Anyone involved in the decision-making process for container closures or responsible for analytical chemistry

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ABC Laboratories

Established in 1968, Analytical Bio-Chemistry (ABC) Laboratories, Inc. is a Contract Research Organization that delivers a broad array of product development and analytical testing services to the Pharmaceutical, biotech, animal health, and chemical industries. The company supports all stages of large and small molecule drug development with expert analytical support, custom synthesis and radiolabeling, environmental assessments and drug development consulting services.

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