Lifecycle Approach to Analytical Methods with QbD Elements: Design, Development, Validation, Transfer

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.

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
• Using QbD Principles to Explore the Method Operable Design Space
• Stage 2: Method Qualification
• Integrating Validation, Verification and Transfer
• Stage 3: Method Performance Verification
• Using Change Control and Risk Assessment
• Questions and Discussion

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

Gregory Martin
Founder and President, Complectors Consulting LLC

Gregory 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 as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances, 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. He is also Past Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.

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.

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