FDA Methods Development and Validation

 Speakers: Dr. M.E. Swartz, Waters Corporation

Course Description:
This course will describe and summarize how to develop, optimize, and validate analytical methods, primarily in HPLC, but applicable to other methods/instrumentation. We will discuss the development of quality control and assurance procedures, standardization of data, validation of data, statistical treatment of data, and confirmation of analytical results. The course is designed for those scientists and managers involved in methods development and optimization, analytical research and development, meeting FDA requirements and regulations, validating analytical methods, application of newer analytical methods, and those involved in quality control, quality assurance, and quality assessment. Some key topics you will learn about include: How to develop a new or improved analytical method; Assessment of method optimization and goals to meet.; Validation of an analytical method before its application.; Application of a newer analytical method.; Method development and optimization in HPLC; and FDA requirements for analytical methods validation and acceptance. You will benefit from this course in the following ways: Become more informed about approaches to methods development.; Learn about how to establish methods optimization guidelines and goals.; Become acquainted with methods to validate a newer analytical method.; Apply newer approaches to methods development and validation by actual     case studies.; Understand methods development and optimization in HPLC.