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Life Sciences Technical Papers

Aseptic Processing Guides Update: USA 2002 Draft and European Community (EC) 2002 Edition in context with ISO 14644-1
Manuel A. del Valle, PE, Director HVAC Design
ISPE Winter Conference, (International Society for Pharmaceutical Engineering) February 17 - 18, 2003, Tampa, FL
Automation Needs Of Process Plants Today: Successful Execution Strategies, And Lessons from A LNG Plant in Mexico Using Main Automation Contractor (MAC)
Romel S. Bhullar,Technical Fellow/Technical Director, Fluor
5th International Congress On Automation, Systems, and Instrumentation, ISA Show South America 2005, November 22-24, 2005, Sâo Paulo, Brazil
Biotech 101: Biotechnology Manufacturing Primer
Jeffrey G. Sarvis, Director Facilities Integration
Palmetto Biotech Initiative 2004, South Carolina: Creating a Competitive Advantage in Biotechnology, April 1 – 2, 2004, Greenville, South Carolina
Biotechnology Facility Design: A Rationale for Compliance
Timothy Mitchell, Director of Regulatory Compliance
Regulatory Affairs Focus, July 2002, Regulatory Affairs Professional Society
Considerations for Renovating Existing Facilities for Expansion or New Product Launch
Oren Webb, Ph.D., Senior Process Engineer
Biopharmaceutical Production Week, November 18-19, 2002, San Diego, CA
Demonstrating the Value of Services Rendered Through the Use of Metrics: Four Keys to Success
Bill Ritchie, PE, Senior Maintenance Engineer
3rd Annual Pharmaceutical Performance Measurement Conference for the Institute for International Research (IIR), Philadelphia, PA, January 29, 2004
Design of Large Scale Fermentation Processes
Chun-Ko Jin, Ph.D., Technical Director
Recent Advances in Fermentation Technology IV Conference (RAFT IV), November 2001, Long Beach, CA
Facility Design Features for Commercial-Scale Multi Product Facilities
Jay Howard, Technical Director
Facilities for Mammalian Cell Products Conference, October 13 - 15, 2003, Coronado, California
HVAC Design for Compliance and Qualification of Aseptic Areas of Biopharmaceutical Facilities
Fred Nowbakh, Director Design Engineering, Fluor
Aseptic Processing & Sterile Processes Conference January 31 – February 3, 2005, Washington, DC
Implementation of an HVAC System in a Multi-Product Biotech Plant
Fred Nowbakh, Principal Mechanical Engineer, HVAC/Utility Department Manager, Fluor South San Francisco
Institute of Validation Technology, March 31, 2003, San Francisco, CA
Laboratories, New Concepts, Basis of Design and Case Studies
Mary Ellen Craft, Project Manager, Fluor; and Frederick L. Fricke Jr., Director, FDA
ISPE Fall 2004 Conference, September 20 – 21, 2004, Durham, NC.
Large Scale Cell Culture Building Design Trends and Case Studies
Jeff Sarvis and Jim Robertson, Directors - Facilities Integration
Interphex 2005
Oral Solid Dosage Equipment: Current Equipment Technology for Manufacturing Solid Form Drug Products
Gregg Herreman, Director of Technology
ISPE Winter Conference (International Society for Pharmaceutical Engineering), February 17 - 18, 2003, Tampa, FL
Process Solution Storage Options: Fixed Vessel, Portable Vessel and Disposable Bag Comparison
Craig Sandstrom, Ph.D., Senior Process Engineer
Williamsburg Bioprocessing Foundation, Nov. 2001, Baltimore, MD
Renovating Facilities for Producing Mammalian Cell Culture Products
Craig Sandstrom, Senior Process Engineer
Williamsburg Bioprocessing Foundation, November 2001, Baltimore, MD
Setting Up and Managing a Validation Program
Shelly Weiss, Validation Regional Manager
Interphex California, December 2001, Long Beach, CA
Specifying a Cost Effective Vaccine Fill & Finish Facility
Majda Imensek, Director of Technology
2002 Parenteral Drug Association (PDA) Meeting, December 10 - 12, 2002, New Orleans, LA
Sterile Manufacturing Facilities HVAC Design Considerations
Manuel A.del Valle, PE, Director HVAC Design
ISPE Winter Conference - "Sterile Manufacturing Facilities: Planning, Design, and Construction" 2 Day Seminar, Feb 11-12, 2002, Tampa, FL
Technical and Regulatory Challenges with Producing Therapeutic Proteins from Transgenic Plant Sources
David Harshbarger, Technical Director
Transgenic BioProcessing Conference, May 8 - 9, 2003, San Francisco, CA