ISPE San Francisco/Bay Area Chapter Technical Articles and Presentations

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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

Download Presentation ( 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.

Download Presentation ( 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.