Method Validation in Drug Development Process - Common Mistakes and Issues 2012

Topics

• Designing appropriate assays
• Importance of defining the method and trending necessary information. Importance of setting appropriate specifications
• Identifying an appropriate reference standard
• Establishing correct specifications
• Creating effective templates for validation studies
• Building on the foundation of a good qualification

Who should Attend

• Laboratory managers monitoring critical systems and reportable results
• Laboratory personnel responsible for day-to-day functioning of laboratories
• Scientific staff involved in assay development, qualification, and/or validation