November 6, 2012

Supply Chain Changes in Phase III/Post-Commercialization: Regulatory Considerations for Container/Closure Systems

Whether it’s the polymer used in a syringe stopper or the adhesive that binds a blister pack, changes in container closure specifications have regulatory implications that can bring manufacturing lines to a screeching halt. The extractables and leachables requirements for phase III/post-commercialization products as a result of planned or unplanned changes in supply chain materials is uncommon territory for many decision makers.

During this webinar, you’ll get practical guidance from CMC experts on a stepwise approach to determining if, what type, and how much extractables/leachables data may be required to address the regulatory concerns.

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.

Ken M. Wong is a subject matter expert in areas of extractable and leachable (E&L) study design, E&L specification strategy development, E&L compliance remediation plan, material change strategy development, risk ranking model design, polymeric contact materials (PCMs) (e.g., single-use system, hoses) qualification, analytical method development and validation with over 14 years of Biopharma industry experience.

Mr. Wong had drafted two E&L guidance documents and PCMs qualification and risk assessment white papers for Schering-Plough and Merck & Co. He is currently representing Merck & Co on Extractable Guidance Subgroup within the Biophorum operations groups (BPOG) and a member on Parenteral Drug Association (PDA) contributing member on the Task Force of the Technical Report on Single-Use Systems.

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.