QbD Approach to Analytical Method Lifecycle Design, Development, Validation, Transfer Goals and Objectives
Friday, June 14, 2013 from 10:00 AM to 12:00 PM (PDT)
Palo Alto, CA
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. 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.
Areas Covered in the Seminar:
- Comparison between Traditional Approaches and QbD Lifecycle Approach to Method Validation
- A QbD Framework for Analytical Method Lifecycle
- Method Design
- Analytical 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
- 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
When & Where
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