Seminar Leaders

• Stephanie Wilkins, PE, President, PharmaConsult US Inc
• James Wood, PE, Engineering Consultant, Eli Lilly and Co

Speakers

• Jeffrey Campie, Sr Dir, Commercial QA, Gilead Sciences
• Justin Cantor, Engineering Project Manager, Gilead Sciences
• Richard Denk, Director, Pharma Dept, Hecht Technologie GmbH/KmpT AG
• Chad Herrman, Senior Chemist, Bureau Veritas North America Inc.
• Junko Kono, Interpreter
• Edwin Melendez, Consumer Safety Officer, FDA/CDER/OC/DMPQ
• Alicia Mozzachio, RPh, MPH, Consumer Safety Officer, FDA
• Christa Myers, Chemical Process Engineer, CRB Consulting Engineers, Inc.
• Srinivas Palakodaty, PhD, Sr. Manager, Manufacturing, Gilead Sciences
• Hisao Takahashi, PE, Director, General Manager, Toyama Chemical Co., Ltd.
• Julian Wilkins, Vice President, PharmaConsult US Inc

Upcoming Schedule

Date  Conference   4-5 June 2007  2007 Washington Conference

In a “town hall” style gathering, the ISPE Facility Summit 2007 welcomes top thinkers and service practitioners from our community to give insight and help advance “the facility of the future.” Hear how manufacturing assets can accelerate the capture of future opportunities and best support an enterprise’s strategic objectives today, and tomorrow.

Design, project delivery, regulatory, manufacturing technology, and operations, all delivered through “rapid-fire” sessions, breakouts, panel discussions, armchair case studies, and virtual tours with the Facility of the Year Awards (FOYA) 2007 Category Winners. The goal of this first Summit is to deliver a broad pallet of key design issues, yet focus on manufacturing challenges.

Who Should Attend
All senior professionals engaged in conceiving, delivering and operating facilities which are regulated, complex, costly, and evolving, and who are in need of gaining state-of-the-art knowledge, or who can contribute to such insight.


Agenda Highlights

Monday, 4 June - Morning

Design: Processing
Green Chemistry (Brooks)
Disposables/Single Use Systems (Reid)
Benchmarking (Other Clean Industries)

Design: Architecture
Building Information Modeling
New “Smart Space” Techniques (Guill)
Q&A With Panelists

Monday, 4 June - Afternoon

Facility Project Management and Delivery
Alternative Project Delivery Approaches (Evey)
Advanced Graphics (Boisvert)
Advanced Project Management Information Systems (PIMS) (Calverisi, Richards)
2007 FOYA Finalists: Case Studies

• (Vazquez, Genentech)
• (Rosselli, Shanghai Roche)
• (Otto, Vetter)
• (Brunkow, Cook Pharmica)
• (Mizuno, Taiyo Pharma)

Q&A With Panelists

Tuesday, 5 June - Morning
Operations and Regulatory Compliance

Pharma Operations/Strategies/Sourcing (Bigelow)
Quality by Design (Impact on Pharma Ops) (D’Eramo, Somma)
Lean Manufacturing Techniques (Gadway, Maslaton)
Commissioning (ASTM) (Petko, Wisniewski)
FDA invited
Q&A With Panelists

Tuesday, 5 June - Afternoon

Roundtables:

• Design
• Project Delivery
• Operations / Compliance
• Panel Discussion
  
  

Event Sponsors