Analytical Method Lifecycle: From Design and Development through Validation and Transfer (Laboratory Training)
Venue: Online Event
|Event Date/Time: Sep 27, 2011||End Date/Time: Sep 27, 2011|
This course is designed to offer a lifecycle approach to assuring analytical methods are suitable for their intended use. After an introduction to the stages of an analytical method, we will discuss each in more detail including concepts and practical suggestions. We will use concepts from ICH and USP documents as well as some additional concepts from a recent paper on a QbD approach to method lifecycle.
At the conclusion of the presentation, there will be ample opportunity for participant questions and discussion.
Agenda: (All time in EDT)
11:00 â€“ 11:20 Introduction: Using a Lifecycle Approach for Analytical Procedures
11:20 â€“ 11:40 Method Design: Introducing the concept of the Analytical Target Profile
11:40 â€“ 12:15 Method Development: Based on the ATP and adapting existing methodology, consider development as a process which anticipates validation needs and uses a QbD approach to exploring limits for enhancing method understanding
12:15 â€“ 1:00 Method Validation: Applying the concepts of ICH Q2 and USP <1225> to demonstrate validation, including situations with multiple potencies
1:00 â€“ 1:15 Break
1:15 â€“ 1:40 Method Modifications: Understanding the rationale for change and addressing effective change control and method revalidation strategies
1:40 â€“ 2:00 Method Verification: Understanding the requirements when a compendial or similar method is brought into the laboratory, and the data elements which must be addressed to verify the method is suitable for its intended use.
2:00 â€“ 2:30 Method Transfer: Identifying acceptable approaches to transfer of methods between laboratories, data elements which must be addressed and appropriate documentation
2:30 â€“ 2:45 Method Troubleshooting: What to do when things do not go according to plan.
2:45 â€“ 2:55 Summary and Conclusions
2:55 â€“ 3:15 Questions and Discussion