Thursday, July 2, 2015

Analytical Method Transfer Delays Not Part of Your Game Plan? (Upcoming ABC Webinar - July 23rd, 2pm EST)


Upcoming Webinar:

Thursday, July 23rd, 2 pm EST

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.

Speaker:
 
Wayland Rushing, Ph.D. 
Senior Scientific Advisor
ABC Laboratories 

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.

Sponsored by:  Established in 1968, Analytical Bio-Chemistry (ABC) Laboratories, Inc. is a Contract Research Organization that delivers a broad array of product development and analytical testing services to the pharmaceutical, biotech, animal health, and chemical industries. The company supports all stages of large and small molecule drug development with expert analytical support, custom synthesis and radiolabeling, environmental assessments and drug development consulting services.

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