QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer

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:

1. Understand the lifecycle approach to method development and validation.
2. Identify an Analytical Target Profile for Methods Being Developed
3. Use an IQ/OQ/PQ Approach to Method Qualification
4. Develop Appropriate Protocols for Method Transfer
5. Comply with Compendial Requirements with Greater Success and Fewer Resources

Areas Covered:

1. Comparison between Traditional Approaches and QbD Lifecycle Approach to Method Validation
2. A QbD Framework for Analytical Method Lifecycle
   1. Method Design
      1. Analtyical Target Profile
      2. Method Development
      3. Method Understanding: Method Operational Space
      4. System Suitability
   2. Method Qualification
      1. Method IQ (Facilities)
      2. Method OQ (Validation)
      3. Method PQ (Real Samples)
   3. Continued Method Verification
      1. Change Control
      2. Method Transfer
      3. Method Verification
3. Correlating This Approach with Compendial Requirements
4. 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

Instructor Profile:

Gregory Martin, is the founder and President of Complectors Consulting LLC, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Greg is Vice Chair of the USP General Chapters Expert Committee, and has over 29 years experience in the pharmaceutical industry, including ten years as Director of Pharmaceutical Analytical Chemistry in Merck Research Laboratories. Greg's interests include impurities and residual solvents, dissolution, analytical instrument qualification and other topics related to laboratory GMP compliance.

Topic Background:

Analytical methods play a key role in assuring that drug substances and drug products conform to their specifications. Demonstrating that these methods consistently perform appropriately for their intended purpose can be both challenging and resource intensive. By using a pro-active, quality-by-design (QbD) approach, it is possible to design better methods, understand the strengths, weaknesses and capabilities of those method and to perform validation exercises in a scientifically rational way that will maximize success and minimize overall resource consumption. This is especially true for the method transfer process, where many examples of tremendous complication can be cited due to inadequacy in method design and development, and due to inappropriate design of method transfer protocols.

Follow us :