When planning your development timeline, the transfer of analytical methods is rarely more than a blip on your radar. But when a method doesn’t perform as expected, it can take precious days of investigative work to find the problem, and even more to correct it. Learn about common pitfalls that cause method transfer failures, how to decide what type of method transfer makes sense for your study, and how to implement a fail-safe communication plan that will help put your outsourcing relationship on the right course.
Wayland Rushing, Ph.D.
Senior Scientific Advisor
Dr. Wayland Rushing is a technical expert in Chemistry Manufacturing and Controls (CMC) program design, analytical development and regulatory submissions. Over his career, he has led CMC development programs for a wide array of biopharmaceuticals, including parenterals, inhalation drugs, and other pharmaceuticals with complex delivery systems. Dr. Rushing is a subject matter expert in HPLC and GC method development and validation, extractables and leachables program design and regulatory submission requirements; has drafted multiple IND and NDA submissions; and assists ABC clients in responding to FDA deficiency letters. He currently serves on Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Defects and was a co-author of the PDA Technical Report No. 65 – Technology Transfer.