3-hr Virtual Seminar: Bioanalytical Method Validation

Speaker : Gwendolyn Wise-Blackman

Gwen Wise-Blackman has 20 years of combined experience in Cell-Based A |  more...

Topic ID : 1216

Duration : 180 Mins

Live : Coming Soon..

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Course Description:

The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics. These methods include analytical procedures that test for identity, purity, potency, and stability of drug substances and drug products. Selecting the right method to validate or if a method is ready for validation starts with the research lab or method development lab. Understanding the requirements for a method to be considered validated helps with the selection process. Also, having a thorough understanding of regulatory agency expectations can prevent unnecessary problems with the acceptance of analytical methods . This 3 hour webinar will describe essential practices for bringing analytical methods from development through validation.

Course Objective:

  • Setting objectives during method development

  • Developing the validation plan

  • Verifying instrumentation and equipment

  • Selecting reference material

  • Setting the validation protocol (validation experiments)

  • Trend analysis of the data from routine use of the method post-validation

  • Changes to the method post-validation

  • Documenting training, validation data, and selection of specifications

Course Outline:

Topics covered include:

  • Understanding “validation”
  • Defining what procedures are required for the drug or biologic
  • Developing new test methods
  • Selecting the reference material/standard
  • Confirmation testing of the reference material/standard
  • Qualifying reagents – determining critical reagents
  • Defining the validation procedure – the protocol
  • Writing the methods to be validated
  • Using compendial methods
  • Acceptance criteria and statistical methods
  • Setting ranges and specifications post validation
  • Training and documentation
  • Life cycle management – revalidation (changes in methods)
  • Method comparability studies

Target Audience:

This webinar will provide valuable assistance to all personnel in:

  • Validation scientists in Bioanalytical laboratories
  • Research or development scientists in Bioanalytical laboratories
  • QA Documentation Specialists
  • Regulatory Specialists
  • Consultants
  • Directors of Outsourcing
  • Laboratory auditors
  • Method trainers
  • Statistical staff