News

Posted On: 10/30/2006

Quality New Jersey, Pharma Manufacturing Co-host Conference on Lean Manufacturing and Rapid Microbiological Methods

PharmaManufacturing.com

Pharmaceutical Manufacturing has teamed up with Quality New Jersey and Celsis to sponsor a one-day seminar on Lean pharmaceutical manufacturing, Rapid Microbiological Methods, and how the FDA has embraced those initiatives. "Lean Pharmaceutical Manufacturing" will be held Thursday, Nov. 9, at the Nassau Inn, Princeton, N.J.

Recognizing that a core challenge for drug manufacturers is the effective implementation and sustainability of Lean initiatives, the sponsors have devised an agenda designed to give participants an understanding of the latest Lean concepts. Attendees will also hear real-world examples of how pharma firms around the globe are using Rapid Microbial Methods to drive manufacturing efficiencies, improve cycle times and manage the cost of quality.

Presentations will include:

• "Applying Lean Manufacturing Principles to the Pharmaceutical and Biopharmaceutical Industries," by Phil Emard, president of OpEx Inc. Emard, an international speaker and leading authority on operational excellence, will advise participants on how to implement proven Lean manufacturing principles and techniques to create financial and operational value for their organizations.



• "Rapid Microbial Detection, a Lean Solution," by Lori Daane, Ph.D., Celsis. Microbiology and Rapid Methods play a key role in a Lean manufacturing environment. Daane will review the technical applicability of these systems in pharmaceutical microbiology and present strategies for streamlining validation.



• "Navigating the FDA Regulatory Process for Rapid Methods," by Diane Younker, Ph.D., Celsis. Implementing Rapid Methods generally includes a regulatory component. Younker will provide an overview of the regulatory submission and approval process for Rapid Methods, discuss Comparability Protocols and share the FDA's current recommendations on Rapid Methods.



• "Case Study: The Regulatory Path to Implementing Rapid Methods at Hoffman-La Roche," by Richard Boehler, M.S., Luitpold, formerly of Hoffman-La Roche. In order to reduce cycle times as part of a Lean initiative, Hoffman-La Roche instituted Rapid Microbial Methods. Boehler will discuss the techology implementation, including the sNDA application and approval process.

For more information or to register, please contact Jim Pasta, meeting coordinator, at (847) 683-1210 or email jim@uponhigh.com.