Analytical Method Lifecycle: From Design and Development through Validation and Transfer

Why Should You Attend:

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.

Who Will Benefit:

Chemists or managers responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.

• QC personnel
• QC Supervisors and Management
• QA personnel
• QA Management
• Regulatory affairs personnel
• R&D Lab personnel
• R&D Lab Supervisors