Analytical Methods and Procedures Training Overview
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.
Results of analytical methods are used as the basis for important decisions during the 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 ongoing 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 the Lifecycle Management of Analytical Procedures, and ICH has recently published guidelines on product lifecycle management.
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 the 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 ongoing routine operation
- Understand what questions will be asked during audits and inspections and how to answer them
Course Content
Course Provider
Ms Kelly Thomas,
Vice President ,
Stallergenes GreerMs. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
