Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance 2016

  • 24 Mar 2016
  • Webinar

Description

Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance 2016 is a webinar that covers topics such as:

  • Learning from the Crystal City FDA/Industry conference report
  • FDA guidelines for bioanalytical method validation
  • Development of a master plan and SOP for validation
  • Logistics of validation
  • Defining parameters and acceptance limits
  • Preparation and use of reference standards and equipment
  • Considerations for Microbiological and Ligand-binding Assays
  • Defining validation experiments
  • Transferring and using the method for routine analysis
  • To revalidate or not after method changes

Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance 2016 is intended for attendees from:

  • QA managers and Personnel
  • Managers and Analysts in bioanalytical laboratories
  • Consultants, Scientists, Technologists, and Engineers in the pharmaceutical industry
  • Validation Specialists
  • Biotech R&D Staff
  • Bioanalytical Scientists
  • Biopharmaceutical Consultants
  • Outsourcing Professionals

Past Events

Important

Please, check "Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Internal Audit & Compliance, Quality assurance
Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare, Hospitals & Clinics, Medical technology
Technology: Biotechnology

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