On November 11, 2010, Dr. Hiltrud Horn will moderate a session on "Analytical Validation Approaches" together with Susan Schniepp.

Further Details about the Workshop:

This Workshop will provide participants with an in-depth review of the laboratory and documentary standards providing guidance on validation requirements for Chemical, Pharmaceutical and Physical Methods and Procedures used in product development and release testing. It will explain what is meant by an analytical method versus a procedure and give examples about their use. The workshop will review the recommendations for appropriate validation of such methods and procedures by looking at ICH, Pharmacopoeial and Regulatory Documents. It will embark in illustrating how to define Design Space in an implemented control strategy under the Quality by Design paradigm.