This 120-minute webinar 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.
This webinar is designed to provide participants with a lifecycle approach to developing and validating analytical methods. 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.
This webinar is designed to provide participants with a lifecycle approach to developing and validating analytical methods. 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.
- Identify an Analytical Target Profile for Methods Being Developed
- Use an IQ/OQ/PQ Approach to Method Qualification
- Develop Appropriate Protocols for Method Transfer
- Comply with Compendial Requirements with Greater Success and Fewer Resources
Areas Covered:
- Comparison between Traditional Approaches and QbD Lifecycle Approach to Method Validation
- A QbD Framework for Analytical Method Lifecycle
Method Design
- Analtyical Target Profile
- Method Development
- Method Understanding: Method Operational Space
- System Suitability
Method Qualification
- Method IQ (Facilities)
- Method OQ (Validation)
- Method PQ (Real Samples)
Continued Method Verification
- Change Control
- Method Transfer
- Method Verification
- Correlating This Approach with Compendial Requirements
- Attendee Questions and Answers
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
Course Provider
Gregory Martin,
