October 10, 2012

You Have Received Extractables Information From Your Container/Closure Manufacturer. Now What?

Program design and regulatory considerations for extractables testing are uncommon territory for many decision makers.

During this webinar, you’ll get practical guidance from CMC experts on how to avoid the most common development hiccups and E&L pitfalls related to container/closure selection and regulatory requirements.

Pharmaceutical and Biotechnology companies, including VPs/Directors/Managers of

• Research and Development
• Product Development
• CMC Operations
• Technical Operations

Plus those involved in the decision-making process for container closures or responsible for analytical chemistry

Dr. Wayland Rushing is a technical expert in all aspects of Chemistry Manufacturing and Controls (CMC) program design, analytical development and regulatory submissions. Over his 12-year 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.

Dr. Rushing currently serves on Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Defects.

With more than 28 years of experience in the pharmaceutical industry, Dr. Moorman has been directly involved in the discovery of novel candidate molecules for a variety of indications, and responsible for designing and implementing optimized chemical and analytical processes for the manufacture of numerous clinical candidates. He is a named inventor on 30 U.S. patents or patent applications and a co-author of more than 40 peer-reviewed publications.

As President of Alta Vetta, he provides development strategy and technical advice in the areas of medicinal, analytical and bioanaltyical chemistry; chemical process development; and Chemistry, Manufacturing and Controls (CMC) issues associated with regulatory filings, having drafted multiple IND and NDA submissions, CMC amendments and annual reports.

Dr. Moorman received his Ph.D. in Medicinal Chemistry from the University of Kansas, followed by an NIH-funded postdoctoral fellowship in Mechanistic Enzymology at Brandeis University.

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.