2-Day Virtual Seminar Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines

Live Seminar Seminar: 2-Day Virtual Seminar Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines When: Thursday & Friday Jun 17 - Jun 18 , 2021 DAY 01 & Day 02 (10:00 AM - 5:00 PM EDT)

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Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in place to ensure suitable levels of reliability, accuracy and precision of such methods. The procedures should cover lifecycle phases from design, development, validation to on-going routine use.
This 2-day workshop will explain the background to the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommended approaches. Interactive exercises will be included in the workshop.
Learning Objectives:
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