Conference Description:

Description

Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays have unique requirements due to the variable nature of some critical components. Although some variability may be inherent, careful attention to setting appropriate limits and to robust qualification of critical components enhances the likelihood of success during validation. This 3-hour webinar will address several parameters that are important for the successful validation of a bioassay. Included in this discussion are multiple challenges that often lead to rework and failure that if appropriately addressed during development should not become issues that hinder validation.

Course Objective

Why method development is critical for a good method validation
Use of DOE
Challenges unique to bioassays
Challenges in cell culture
Handling critical reagents
Identifying and managing analyst variability
Details of the written method
Defining the validation process
Data Analysis
Learning from failures
Timelines and Continuous Improvement

Course Outline

Topics covered include:

Process of method selection
Selection and certification of the reference standard
Setting appropriate limits for reagents
Reagent supply and sample handling
Pre-test of critical reagents
Testing robustness/ruggedness/selectivity/specif icity prior to validation Analyst training
Peer review of the test method
Statistical analysis
Validation protocol and templates
Preplanning
Documentation of deviations and failures

Target Audience

Method development scientists (pharmaceuticals, biopharmaceuticals, dietary supplements)
Method validation scientists (pharmaceuticals, biopharmaceuticals, dietary supplements)
Quality control professionals (pharmaceuticals, biopharmaceuticals, dietary supplements)
Quality assurance professionals (pharmaceuticals, biopharmaceuticals, dietary supplements)
Manufacturing professionals (pharmaceuticals, biopharmaceuticals, dietary supplements)
Laboratory managers (pharmaceuticals, biopharmaceuticals, dietary supplements)
Auditors (pharmaceuticals, biopharmaceuticals, dietary supplements


Speaker: 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 Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.

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