Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the pharmaceutical 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.

Managing analytical methods and procedures according to the lifecycle approach has been recommended in recent FDA guidance documents and stimuli articles published by the USP. For example, the recent FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” contains a section on Lifecycle Management of Analytical Procedures, and ICH has recently published guidelines on product lifecycle management.

This 2-day course will explain the background to the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommended approaches.

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 USP General Chapter 1210 (Statistical Tools for Procedure Validation), 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

Who will Benefit:
QA managers and personnel
Quality control scientists
Method development scientists
Analytical chemists
Validation specialists
Laboratory managers and supervisors
Regulatory affairs professionals
Training departments
Documentation departments
Consultants