Lifecycle Approach to Analytical Methods: Incorporating QbD Principles into Method Development, Validation and Transfer

Description
This 90-minute webinar on using the Lifecycle Approach to Analytical Methods is designed to provide participants with a lifecycle approach to developing and validating analytical methods with improved outcomes for routine use and transfer.

Objectives of the Presentation
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

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
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 can Benefit
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

For Registration
http://onlinecompliancepanel.com/webinar/ANALYTICAL-METHODS-501375/MAY-2016-ES-WORLDCONCAL

Note: Use Promo code VBTPK and get 10% off on registration (Valid till May 31st 2016)