Lifecycle Approach to Analytical Methods with QbD Elements: Design, Development, Validation, Transfer

This training on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements.

Why Should You Attend:

This webinar is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including some elements aligned with QbD concepts. By using a lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises.

The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the method is expected to accomplish), fostering method understanding (using QbD concepts to explore the method operable region and stressing the importance of real samples in the environment where they will be tested) and demonstrating how these principles can be used iteratively as methods change location or evolve technically. This approach will be linked with current compendial requirements. There will be an opportunity for questions and answers at the end of the presentation.

Learning Objectives:

• Understand the lifecycle approach to method development and validation.
• Learn more about the three stages of an analytical method lifecycle.
• Identify an Analytical Target Profile for Methods Being Developed.
• Understand how validation, verification and method transfer are interrelated.
• Comply with compendial requirements for verification with greater success and fewer resources.

Areas Covered in the Webinar:

• Introduction: Using a Lifecycle Approach for Analytical Procedures
• Stage 1: Method Design, Development and Understanding
• Using an Analytical Target Profile to Guide Development
• Using QbD Principles to Explore the Method Operable Design Space

Stage 2: Method Qualification

• Integrating Validation, Verification and Transfer

Stage 3: Method Performance Verification

• Using Change Control and Risk Assessment
• Questions and Discussion

Who Will Benefit:

This webinar will provide valuable assistance to all Biotech & Pharmaceutical companies/manufacturing sites. Those that would benefit most would be:

• Chemists (Research, Quality Control, CRO) involved with analytical method development, validation or transfer and their managers
• Regulatory affairs/CMC personnel responsible for documenting analytical methods and their acceptability
• Laboratory managers and staff
• Analysts
• QA/QCU managers and personnel
• Training department
• Documentation department
• Consultants