February 2012 Commuter Conference: A Framework for Technology Transfer to the Emerging Markets to Satisfy
the New Process Validation Guidance
Presented on 21 February 2012
Bikash Chatterjee, Pharmatech Associates
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2 MB)
2011 Code Update
Presented on March 3, 2011
Based on the International Building, Fire, Plumbing and Mechanical Codes
by Reinhard Hanselka, PhD, REA, Sr, Associate Evergreen Engineering and President, AIDI, Inc.
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3 MB)
ISPE San Francisco/Bay Area Chapter
2010 Dinner Meeting
Evolving Technologies: Lab-on-a-chip
16 September 2010
Integrated Microfluidic Systems in Challenging
Environments: Biological Studies in Earth Orbit (
3 MB)
Tony Ricco
NASA Ames Research Center, Moffett Field, CA
ISPE San Francisco/Bay Area Chapter
Brewery Tour & Presentations
24 June 2010
Fermentation of Beer (
1 MB)
Dan McAdam
Bayer HealthCare, Emeryville
Biotech Cell Culture Development (
3 MB)
John Thrift
15 September 2009
How Strong is Your Cold Chain? (
5 MB)
Andy Malcolm, P. Andrew, Malcolm Consulting
Thermal Packaging Solutions, LLC
NOTE: This presentation is to be used in its entirety. Please do not pull individual
pages from the presentation.
10 September 2009
Contract Manufacturing in Biotechnology (
1 MB)
Dan Moskey, Associate Director at Genentech
Vacaville Technology
Technology Transfer in Biotechnology (
754 KB)
Herwig Kapeller, Director of Manufacturing Technology
Novartis Pharmaceuticals
9 September 2008 Presentation
Innovative Project Delivery (
3 MB)
Glenn Ballard, Lean Construction Institute
Project Production Systems Laboratory
13 May 2008 Commuter Conference
Turn Over Packages, FAT and Commissioning (
2 MB)
Misha Anissimov, Genentech
Mike Britting, Hathaway Dinwiddie
Leo Santini, Hathaway Dinwiddie
24 April 2008 "Quality by Design" meeting
Quality By Design (
524 KB)
Gail Burnett, Ph.D.
Presentations from Feb 28, 2008 Vendor Night
Technologies of the Future: Using Disposables to
Build a Flexible Manufacturing Capacity (
685 KB)
Geoffrey Hodge, VP Process Development & Technology, Xcellerex
Technologies of the Future: Disposables at
Genentech (
421 KB)
Chris Lorenz, Process Development Engineering
How to be fast: Modular engineering Concept (
1 MB)
Ole Baekgaard, NNE Pharmaplan
Commuter Conference - Jan 15 2008
Modular Construction - Addressing the Needs of the
Bio-Pharmaceutical Industry (
2 MB)
Paul Hochi, Jacobs
Why, When, How to Benefit from Modular
Projects (
2 MB)
Lena Lasarzewski, Pharmadule, Inc.
May 10, 2007 - Biotech Going Green meeting
"Sustainability at Roche Palo Alto" (
678 KB)
Jerry Meek
"ALZA Landfill Gas Case Study" (
2 MB)
Scott Colpitts
March 1, 2007
"Six Sigma and its relationship to other operational
excellence approaches such as Kepner-Tregoe and Lean Manufacturing" (
3 MB)
Bikash Chatterjee, President, Pharmatech Associates, Inc.
"An Overview of Lean and how to Adopt Lean in
Biotech" (
940 KB)
Fadel Hamed, PhD, PROP Operational Excellence, Genentech
2007 New California Building, Fire and Mechanical Codes:
Changes Every Facility Needs To Know, 25 September 2006
California Codes for 2006 and Beyond (
5 MB)
Presented by Reinhard Hanselka and Jeff Tarter
May 18, 2006
Long Range Capital Planning (
2 MB)
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
January 26, 2006
Leadership in Manufacturing and Engineering
Organizations (
2 MB)
Patrick Y. Yang, Ph.D., Executive Vice President, Product Operations, Genentech
9 August 2005
Commissioning and Close-out of Technically Complex
Buildings: A Lifecycle Approach (
2 MB)
Ric Holman and Adam Benzuly, Affiliated Engineers, Inc.
28 June 2005
Pharmaceutical Water Systems (
616 KB)
Mason P. Waterbury, Nektar Therapeutics
When Things Go Wrong (
701 KB)
By Brent Parry of Alza and Kelly Keen of Webcor Builders - 2005
GAMP (
530 KB)
By Klaus Krause - 2004
Codes for 2004 and Beyond (
3 MB)
By Reinhard Hanselka - 2004
Stainless Steel Tubing in the Biotechnology
Industry (
70 KB)
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.