2021 - Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines

Learn about the regulatory background and recommendations for managing the lifecycle of analytical methods and procedures
Understand current and future industry trends: the concept of lifecycle management of analytical methods, recent ICH guidance (ICH Q12), proposed USP General Chapter <1220> (Analytical Procedure Lifecycle) and Quality by Design (QbD) principles for method development and validation
Learn how to plan, execute and document design, development and validation of methods developed in-house
Understand the principles of lifecycle management for compendial procedures and for managing method transfer
Be able to develop a strategy for analytical procedure lifecycle management
Understand risk management strategies throughout the procedure lifecycle
Understand the concept of measurement uncertainty
Be able to justify and document decisions about type and extend of revalidation after method changes
Be able to define and demonstrate FDA, EU, USP and ICH compliance to auditors and inspectors
Be able to develop inspection-ready documentation during on-going routine operation
Understand what questions will be asked during audits and inspections and how to answer them