Moderators: Joseph Famulare, Deputy Director, Office of Compliance, CDER, FDA, Rockville, MD and Janice Whitaker, Senior Vice President of Quality, GSK, RTP, NC

Date and Venue: Sunday afternoon, January 27, 2008, 1:00PM - 5:00PM
Baltimore Marriott Waterfront, Baltimore, MD, USA

Objective: Identify key business drivers and sound implementation strategies for Process Analytical Technology (PAT) within the pharmaceutical and biopharmaceutical industries with the goal of achieving successful PAT applications supporting Quality by Design and Manufacturing Excellence.

The Program: The US FDA's PAT initiative was launched in 2002 and was a starting point for a new way of thinking in the pharmaceutical and biopharmaceutical industries. Today PAT is still playing an important role as a key enabler for implementation of Quality by Design (QbD) and the 3 important guidelines from the International Conference of Harmonization (ICH); Q8 on Pharmaceutical Development, Q9 on Quality Risk Management and Q10 on Quality Management.

These initiatives all aim to stimulate the implementation of new efficient, science based approaches to manufacturing that ensure a predictable product quality output and increased manufacturing efficiencies; the cornerstones for achieving manufacturing excellence.

Presentations at this IFPAC-08 pre-conference event will describe PAT applications where the business benefits were achieved, as well as, applications where they were not achieved until the approach was modified. The event will share learning from real case histories from the pharmaceutical industry, as well as, from practical implementation outside the pharmaceutical industry. The attendees will learn how to ensure the success of PAT projects supporting Quality by Design within their organization and to generate a deeper understanding of the business benefits that can be used to drive this change within their organization.

The program will conclude with an open exchange between attendees, presenters, and key industry and regulatory agency representatives to generate a better understanding of impediments to PAT utilization and how these can be addressed to increase the rate of successful implementation of PAT by the industry.

The seminar is designed for pharmaceutical and biopharmaceutical executives, managers and technical leaders who are responsible for making decisions concerning approaches to product and process development, product quality control, and process automation and control. These decision leaders may reside in business units such as: process development, manufacturing, engineering, quality control, regulatory, and/or or have oversight responsibility for these business units.

The program will end with an interactive roundtable discussion that encourages audience participation, which will be an opportunity for strong networking amongst senior decision makers and professionals.

Partial list of speakers and roundtable participants at this event include:

Moheb M. Nasr, Ph.D., Director, Office of New Drug Quality Assessment (ONDQA, CDER, FDA), Silver Spring, MD

Joseph Famulare, Deputy Director, Office of Compliance, CDER, FDA, Rockville, MD

Janice Whitaker, Senior Vice President of Quality, GSK, RTP, NC

Additional speakers will be announced later.

Join us at the IFPAC Executive Seminar and check our web pages for further updates: www.ifpac08.org/executive