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3-hr Virtual Seminar: Understanding Requirements of a Bioanalytical Method Validation

Duration : 3 Hours

Gwendolyn Wise-Blackman,

Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method De Read more


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.  Clinical laboratories also must follow stricter procedures for accreditation and validation of test methods per current ISO requirements.

Selecting the right method to validate or if a method is ready for validation starts with the research lab or method development lab and data that support the decision to proceed.  Understanding the requirements for a method to be considered validated helps with the decision-making 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 in laboratories supporting biologic products as well as clinical laboratories.

Course Objective:

• Verifying instrumentation and equipment
• Setting objectives during method development
• Using DOE to support data-driven go/no go decisions
• Developing the validation plan
• 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:

• 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)

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Validation scientists in bioanalytical or clinical laboratories
• Development scientists in bioanalytical or clinical laboratories
• QA Documentation Specialists
• Regulatory Specialists
• Consultants
• Directors of Outsourcing
• Method trainers
• Statistical staff

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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