Technical Articles and Presentations

May 13, 2008 Commuter Conference

Turn Over Packages, FAT and Commissioning
Misha Anissimov, Genentech
Mike Britting, Hathaway Dinwiddie
Leo Santini, Hathaway Dinwiddie

April 24, 2008 "Quality by Design" meeting

Quality By Design
Gail Burnett, Ph.D.

Presentations from Feb 28, 2008 Vendor Night

Technologies of the Future: Using Disposables to Build a Flexible Manufacturing Capacity
Geoffrey Hodge, VP Process Development & Technology, Xcellerex

Technologies of the Future: Disposables at Genentech
Chris Lorenz, Process Development Engineering

How to be fast: Modular engineering Concept
Ole Baekgaard, NNE Pharmaplan

Modular Construction - Addressing the Needs of the Bio-Pharmaceutical Industry
Paul Hochi, Jacobs

Why, When, How to Benefit from Modular Projects
Lena Lasarzewski, Pharmadule Inc.

"Sustainability at Roche Palo Alto"
Jerry Meek
May 10, 2007 - Biotech Going Green meeting
(PDF, 678 KB)

"ALZA Landfill Gas Case Study"
Scott Colpitts
May 10, 2007 - Biotech Going Green meeting
(PDF, 1.9 MB)

"Six Sigma and its relationship to other operational excellence approaches such as Kepner-Tregoe and Lean Manufacturing"
Bikash Chatterjee, President, Pharmatech Associates, Inc.
March 1, 2007
(PDF, 3 MB )

"An Overview of Lean and how to Adopt Lean in Biotech"
Fadel Hamed, PhD, PROP Operational Excellence, Genentech
March 1, 2007
(PDF, 940 KB)

Update on "L" Occupancy and New California Fire Code
by Reinhard Hanselka, Principal Chemical Engineer, IES
March 1, 2007
This presentation is available for download:
http://www.intengr.com/?q=node/58#attachments

California Codes for 2006 and Beyond
Presented by Reinhard Hanselka and Jeff Tarter
2007 New California Building, Fire and Mechanical Codes: Changes Every Facility Needs To Know, 25 September 2006
(PDF,  5 MB)

Long Range Capital Planning
Facilitator: Vic Warren, Architect, bioTechure
Panelists: Patricia Turney, Director of R&D Strategic Operations, Amgen
Jim Andrews, Associate Director, Nektar Therapeutics
Bubba Brueil, Chief Financial Officer, Codexis
Lid Sodbinow, Director of Capital Projects, Engineering, Novartis
May 18, 2006
(PDF, 2 MB)

Leadership in Manufacturing and Engineering Organizations
Patrick Y. Yang, Ph.D., Executive Vice President, Product Operations, Genentech, January 26, 2006
(PowerPoint, 2.25 MB)

Key Issues in Potent Compound Manufacturing and Barrier Technology
Mark Karabatak, PSGA West, 8 September 2005
(PowerPoint, 38 MB)

Commissioning and Close-out of Technically Complex Buildings: A Lifecycle Approach
Ric Holman and Adam Benzuly, Affiliated Engineers, Inc. 9 August 2005
(PowerPoint, 2.44 MB)

Pharmaceutical Water Systems
Mason P. Waterbury, Nektar Therapeutics, 28 June 2005
(PowerPoint, 616 KB)

When Things Go Wrong
By Brent Parry of Alza and Kelly Keen of Webcor Builders - 2005
(PDF, 701 KB)

GAMP
By Klaus Krause - 2004
(PDF, 551 KB)

Codes for 2004 and Beyond
By Reinhard Hanselka - 2004
(PDF, 2.74 MB)

Roundtable Drug Development Discussion
By Tom Yonker of Inermune
Amongst discussion topics are the clinical trial phases and the FDA review process. 2003

Annual Shutdowns
By George Rally, Al De Groot and Rick Bible
Technical session - plant shutdowns from planning through execution and closeout. 2003

Value Engineering
Larry Oesterich and Sharron Reiss-Miller - 2002

Applying On-line TOC Monitoring in USP Water Systems: Benefits and Pitfalls
Thomas Main - 2002

Design of Engineering Systems For global Pharaceutical Facilities
By Mark M. Maguire, PE, Kling-Lindquist

Stainless Steel Tubing in the Biotechnology Industry
By Michelle M. Gonzalez
This article describes stainless steel types and their chemistry, tubing/piping fabrication standards, and fabrication procedures, including compliance with biotechnology and pharmaceutical standards.

Presentations from "Design of Modular and Prefabricated Facilities"
Commuter Conference - Jan 15 2008