- Learn how to use a Lifecycle Approach to apply QbD concepts to Analytical Methods
- Learn how the Analytical Target Profile can drive the Lifecycle Approach
- Discover how a lifecycle approach can link method development, validation, verification and transfer and continued method use
- Learn about the importance of linking method uncertainty to specifications
- Using a method feedback loop to facilitate method improvement
This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. The course starts by introducing the Lifecycle Approach and discussing some of the key terms. By using the 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 interaction throughout the course.
Learning Objectives:
- Understand the lifecycle approach to method development and validation.
- Understand the different types of methods required for different types of drug products, and the various types of impurities which must be addressed
- 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
Who will Benefit:
Chemists, supervisors, managers or directors from pharmaceutical (human and veterinary), generic or OTC companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.
- Registration Process: 8:30 AM – 9:00 AM
- Session Start Time: 9:00 AM
- Introduction: Using a Lifecycle Approach for Analytical Procedures
- Discussion of terminology used in the Lifecycle Approach
- Method Design: Introducing the concept of the Analytical Target Profile
- PRACTICAL EXERCISE: Developing an ATP
- Method Development Using the ATP as a Tool
- Assay or uniformity, Stability indicating methods, Dissolution
- Knowledge Gathering and Knowledge Management
- Risk Assessment and Analytical Procedure Control Strategy
- PRACTICAL EXERCISE: Approach to developing a stability indicating method
- Method Qualification: Validation, Verification, Transfer
- Rationale for demonstrating the validity of an analytical method
- Life cycle approach to method validation
- Design of validation experiments
- Establishing acceptance criteria
- PRACTICAL EXERCISE: Designing a validation protocol
- Continued Procedure Performance verification
- Routine monitoring, trend analysis, continuous improvement
- Method Modifications: Change control and method revalidation strategies
- Troubleshooting analytical methods
- Review and Opportunity for Additional Questions
Gregory P. Martin
President of Complectors Consulting LLC
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.
He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation, and is past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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