QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer 2019

Topics

• The three stages of an analytical method lifecycle
• The lifecycle approach to method development and validation
• How validation, verification and method transfer are interrelated
• Analytical Target Profile for methods being developed
• Complying with compendial requirements for verification with greater success and fewer resources

Who should Attend

• Regulatory affairs/CMC personnel responsible for documenting analytical methods and their acceptability
• Chemists (research and quality control personnel) involved in analytical method development, validation or transfer
• Analysts
• Laboratory managers and staff
• Training department
• QA/QCU managers and personnel
• Consultants
• Documentation department