An upcoming event that may have flown under your radar is “Operational Excellence: A Lifecycle Approach to Assuring Drug Quality,” to be held April 5 – 6 at the Hyatt Regency in Bethesda. It’s a great, relevant topic, of course. But what distinguishes this conference–sponsored by NIPTE–is the impressive lineup of speakers, from FDA, industry, academia, and consulting and vendor companies.

They include:

• FDA’s Helen Winkle, Christine Moore, Brian Hasselbalch, and Grace McNally
• Biogen Idec’s Justin McCue, J&J’s Paul McKenzie, Crucell’s Alain Prolong, and Vertex’s Eda Ross Montgomery
• Duquesne’s Jim Drennan and St. Gallen’s Thomas Friedli
• Consultants Chris Watts, Ali Afnan, and Ted Fuhr
• Emerson’s Melissa Herkt and Michalle Adkins, and Invensys’ Peter Martin

Many of these individuals, of course, have helped to shape and further the ideals of Quality by Design.

The event is also accredited, with the following learning objectives:

• Discuss the current state of the FDA’s Quality by Design (QbD) implementation, lessons learned and the hurdles being faced in
  its implementation.
• Explain and demonstrate how embracing new technologies such as continuous manufacturing and establishing a culture of continuous improvement can have a positive financial impact on pharmaceutical companies’ bottom line.
• Describe what the FDA’s review and inspection teams expect of the pharmaceutical companies in the area of implementation of new technologies and operational excellence.
• Implement a successful “Lean” and operational excellence program in manufacturing units.
• Prepare for inspections by anticipating the issues that can lead to non compliance.
• Benchmark one’s own operation with other similar pharmaceutical operations around the world.

Registration information can be found here. (Scroll down and you’ll find information on another noteworthy gathering: “Critical Path Research for Process Scale-up and Stability,” taking place in June.)

–Paul Thomas

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