QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and 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. The webinar presenter will use case studies to illustrate each stage in the process.

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.

The webinar instructor, a leading expert on the subject, will use his industry knowledge in presenting relevant case studies to increase participants’ understanding of the three stages of an analytical method lifecycle.

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

• Case study

Using QbD Principles to Explore the Method Operable Design Space

• Case study

Stage 2: Method Qualification

• Integrating Validation, Verification and Transfer

Case study

• Stage 3: Method Performance Verification

Using Change Control and Risk Assessment

• Case study
• Questions and Discussion

Who Will Benefit:

This webinar will provide valuable assistance to personnel in biotech and pharmaceutical companies/manufacturing sites, including:

• Chemists (research and quality control personnel) involved in analytical method development, validation or transfer
• 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