ISPE SF Newsletter November 2014

Transcription

ISPE San Francisco/Bay Area Chapter Newsletter
Newsletter
Deadline:
1st Day of Each
Month
Save These
Dates!
All ISPE
California
Events
Featured in
Emails
20 November 2014
ISPE Los Angeles
Chapter
Evening with Industry
Executives and Chapter's
20th Anniversary Party
11 December 2014
ISPE San Francisco
Chapter Dinner Meeting
at DoubleTree Berkeley
Marina
President's Message
By Simon Forder, Principal Consultant and CEO
Hyde Engineering + Consulting, Inc.
I wanted to send a note of introduction. My name is Simon Forder and I am
your new ISPE San Francisco/Bay Area Chapter President. I will serve you
until August 2015. I am excited about the opportunity to serve the Bay Area
Board and help build our Chapter. A lot of you know me, but for those that
don't, I'll take a minute and answer the question: Who is Simon Forder?
I grew up in the Bay Area after emigrating to the USA from England when I was
two years old. I went to high school in the North Bay and was first introduced to
the biotechnology business during a career day. At the career day, Herb Boyer
(Founder of Genentech) spoke of the "biotechnology revolution" that was coming and how we students
needed to get involved. As a result, I found myself drawn to studies at UC Davis that prepared me for the
Biotechnology industry ( there were no Biotech programs in those days). I then graduated and got my first
job at Cetus. From Cetus, I started with a company called Biosys and we worked with Archer Daniel
Midlands (Supermarket to the World!) on a number of products. From ADM, I worked for Inhale
Therapeutics (Nektar - now Novartis) and then on to Hyde Engineering + Consulting. I have been at Hyde
for 11 years now. Along the way, I have met so many great people. People I call friends, mentors, and
people I have truly enjoyed working with. Many of them are ISPE Members and this was how I became
involved in the local Chapter.
The Chapter will be publishing this newsletter once a month this year. I plan to write a once-a-month
Presidents message. Next month, I will give some updates from the ISPE Annual Meeting as well as some
info on what we will be focusing on this year. Stay tuned!
Regards,
Simon Forder
For information on San Francisco / Bay Area Chapter events, or to
become a member of the Chapter, contact Chapter Manager Kimberly
Syre by telephone at +1-949-387-9046 or by email at ksyre@cox.net.
Chapter President Simon Forder can be reached
at simon.forder@hyde-ec.com.
Oktoberfest Photos
2015 Working
Calendar
(subject to change)
Last month was the Chapter's Oktoberfest social event at Steelhead
Brewing Company in Burlingame.
21 January 2015
ISPE LA Chapter
Program
29 January 2015
ISPE San Francisco
Chapter CEO Night
30 January 2015
ISPE San Diego and LA
Chapter Joint Temecula
Winery Tour
26 February 2015
ISPE San Diego Chapter
Electrical Utilities and
Water Infrastructure
Simon Forder was introduced as the Chapter's new
President.
(L-R) Chapter's President Simon Forder of Hyde
Engineering + Consulting and Fun Day Chair, Trevor Auer
of CRB.
10 February 2015
ISPE San Francisco
Chapter
Commuter Conference
18 February 2015
ISPE LA Chapter
Program
21 February 2015
ISPE San Francisco
Chapter Young
Professionals Leadership
Forum
(L-R) Sandeep Patel of Nexus Automation and Chapter's Outgoing
President David Bendet of Perkins + Will Architects.
12 March 2015
ISPE San Francisco
Chapter
Vendor Night and Student
Poster Contest
18 March 2015
ISPE LA Chapter
Program
19 March 2015
Who's Coming, Who's
Going in San Diego
Shawn Mazzeo of Project Management Advisors.
2 April 2015
Networking Bowling
Event
8 April 2015
ISPE LA Chapter
Program
16 April 2015
ISPE San Francisco
Chapter
Evening Meeting
(L-R) Marlene Meza of
Grifols and Patti Larson of
XL Construction.
Advisory Council Update
by Sue Cost of Harris Group
1 May 2015
ISPE San Diego
Spring Golf Tournament
La Costa
7 May 2015
ISPE LA Chapter Vendor
Night
19 May 2015
ISPE San Francisco
Chapter
Commuter Conference
24 May 2015
ISPE LA Chapter
Program
18 June 2015
ISPE San Francisco
Chapter
Facility Tour for Members
Only
25 June 2015
CEO Night
15 July 2015
ISPE LA Chapter
Program
16 July 2015
ISPE San Francisco
Chapter
Fun Day Golf Tournament
and Winery Tours,
Chardonnay Golf Course
Napa, CA
23 July 2015
Networking Event
6 August 2015
Vendor Night
7 August 2015
Golf Tournament
18 August 2015
ISPE San Francisco
Chapter
Commuter Conference
19 August 2015
ISPE LA Chapter
Program
3 September 2015
Networking Event
16 September 2015
ISPE LA Chapter
Program
24 September 2015
ISPE San Francisco
Chapter
Evening Meeting
7 October 2015
Clinical to Commercial
Meeting
8 October 2015
ISPE LA Chapter
In September the Board of Directors and the Program Committee met with the Advisory Council to have an
interactive planning session for potential future topics. The Advisory Council is made up of key executives
from the local owner/operating companies. We had an
excellent turnout and very productive evening.
The goal of the session was to have an informal
discussion on topics and issues that owners are
facing in the industry and establish a list of topics from
which ISPE can use as future topics for programs,
commuter conferences or ad hoc committees. We
identified topics both of current concern and interest
and as related to future direction of the industry as
well as for Bay Area technology growth. The program
committee will now take that information and will begin
the planning process for future programs.
Thank you to all of the participants:
Jane Adams, Quality and Regulatory Compliance
Consultants
Trevor Auer, CRB
Michael Batie, Bayer HealthCare Pharmaceuticals
David Bendet, Perkins+Will Architects
Michael Cooper, BioMarin
Sue Cost, Harris Group
Scott Donald, Grifols
Ralf Elsaesser, Dome Construction
Ross Graves, CRBE
Matt Gray, BioMarin
Wei Huang, Newa Technologies
David Huff, Genentech
Drew Johnston, Bayer HealthCare Pharmaceuticals
Logan Kelley, BioMarin
Binh Le, Gilead Sciences
Andy Lorenc, Grifols
Jim Redenbarger, BioMarin
Joe Tarentino, Novartis Pharmaceuticals Corporation
Brian Vaughn, CRB
Corey Veverka, TVS
See complete list of Advisory Council Members below.
15 Oktober 2015
ISPE San Francisco
Chapter
Oktoberfest
End of October 2015
& Biocom
Joint Facilities Reception
3 November 2015
ISPE San Francisco
Chapter
Commuter Conference
Chocolate Factory Update
by Heather Bennett of ACCO Engineered Systems
The school year has started and the ISPE SF
Chocolate Factory is off to a great start. This
program teaches 5th graders about construction and
the pharmaceutical industry by building models of
chocolate factories. DPR and the ISPEstudents at
San Jose State University have already volunteered their time, and there are dates still open for companies
to sign up and help out in 2015: 1/30, 3/6, and 5/8.
4 November 2015
ISPE LA Chapter
Evening with Industry
Executives
If you cannot volunteer, or want to help out in another way, financial donations are also welcomed and very
needed(goes directly to the school district). Email me to invest in the future of our industry.
hbennett@accoes.com
8-11 November 2015
ISPE Annual Meeting
Philadelphia, PA
Japan Affiliate Plant Tour
3 December 2015
ISPE San Francisco
Chapter
Evening Meeting TBD
by Michael Lucey of JGC Corporation
10 December 2015
Networking Event
All events subject to
change due to availability
of venue/speakers.
To Register for Any ISPE
LA, SD or SF Chapter
Meetings:
http://www.atdevents.net
ISPE's Global Calendar
and Additional ISPE
Educational Offerings and
Publications:
www.ispe.org
With the leadership and support of the San Francisco & Bay Area Chapter, and organized from Japan by
Shigeru Nakamura, Affiliate Vice Chairman, and Michael Lucey, Adjunct Director, closely supported by the
Committee members, the "2014 US Pharmaceutical Plant Tour" group visited multiple plants in the Bay
Area over three days from October 8 to 10. This was followed by a facility visit in Santa Monica and then
participation by all at the ISPE Annual Meeting in Las Vegas. The travelling group from throughout Japan,
all ISPE, comprised a total of 20 members.
The Novartis campus visited, secured with the efforts of Dome as constructor, is conveniently located in
San Carlos just a short drive from San Francisco. It was quickly noted that the facility is unique in that it
functions as a technology research & development (TRD) site as well as a commercial production facility for
the pharmaceutical business, employing more than 250.
The TRD site is focused on the development of pharmaceuticals for respiratory diseases. Prime function is
the production of dry-powder Tobramycin inhalant for the TOBI Podhaler used in the prevention/treatment of
chronic pulmonary diseases.
Although the production suite room was at the commissioning stage, Tour members were permitted to enter
the clean area and were able to closely observe actual equipment and engage in valuable Q&A time.
It was a highly informative visit and all of from Japan wish to express their sincere gratitude to those
responsible at Novartis and Dome for creating s
uch an excellent opportunity. Impressed to the last,
great delight was taken by the visitors at departure in
the large-sized heavyweight "ball" of expired badges-a
fine testament to the many who have been permitted to
share in the facility!
Apply Now For the 2015 Facility of the Year Award All submissions due by 24 November 2014
There is still time to submit your application for the 2015 Facility of the Year Awards (FOYA). In its eleventh
year, FOYA recognizes innovation and creativity in manufacturing facilities serving the regulated healthcare
industry.
Projects selected for these prestigious awards set the standard for pharmaceutical facilities of the future by
demonstrating excellence in Project Execution, Facility Integration, Equipment Innovation, Sustainability,
Process Innovation and Operational Excellence.
Award winners will:
Be acknowledged by global regulators, industry colleagues and
business leaders as the driving forces in the future of the
pharmaceutical and biotechnology industry.
Be recognized and presented in front of industry peers and regulators at a special gala event during ISPE's
2015 Pharmaceutical Quality Week.
Be honored during the 2015 ISPE Annual Meeting.
Receive high-profile coverage in ISPE's Pharmaceutical Engineering magazine, distributed to 20,000
readers in 90 countries.
To be considered, all materials must be submitted to ISPE by 24 November 2014.
For more information about FOYA and applying, please visit the Facility of the Year Awards website.
http://www.facilityoftheyear.org/
Questions? Contact Michael Phelan, ISPE Director of Volunteer
Development and Industry Recognition at 813-739-2273 or
mphelan@ispe.org
Thank You Newsletter
Advertisers
RONN NELSON
AREA MANAGER
ronn@duhig.com
STAINLESS
Insight to Operation
People | Process | Product
5071 TELEGRAPH RD.., LOS ANGELES, CALIFORNIA 90022
Los Angeles
(323) 263-7161
San Diego
(760) 560-0090
Modesto
(209) 521-7135
Cell (323) 346-7522
www.duhig.com
cagents.com
Commissioning Agents Inc
USA | Canada | Puerto Rico | Europe | Asia
astropak.com
est. 1959
Call Today! 703.542.0608
Control Solutions for Evolving Plants...
in the Life Science Industry
and Industrial Process Automation
Contact:
Greg Banks, President 707.451.1100 Ext. 203 • Cell 707.330.5860
600 E. Main Street, Suite 200, Vacaville, CA 95688 • www.BanksIntegration.com
Sandra Medlin
(510) 290-1232 Cell
smedlin@Sani-TechWest.com
1-800-726-4835
www.Sani-TechWest.com
www.SaniSure.com
1020 Flynn Road Camarillo, CA 93012
Thank You Newsletter Advertisers
VALIDATION
Chambers, sterilizers, warehouses
CALIBRATION
NVLAP Accredited and NIST traceable
GMP STORAGE
From -196°C to 70°C environments
RENTALS/SALES
For validation and calibration
MONITORING
Continuous, wireless solutions
978.433.6279 | masy@masy.com | www.masy.com
Global Leader in BioPharma Process Systems Support Northern California Office
48400 Fremont Boulevard
Fremont, CA 94538
Tel. 510-683-6000
Fax. 510-683-6001
Contact: Mike Nielsen
Mike.nielsen@kinetics.net
COMPLIANCE SERVICES
Susanne Lagé Cost
Business Development Director
Lafayette, CA
925.297.6284
Sue.Cost@harrisgroup.com

Process Development
Critical Utility Design
cGMP and R&D Facility Design
Regulatory Support
www.harrisgroup.com
VALIDATION
Tony Garbarino
Director of Biotechnology
Lafayette, CA
925.297.4575
Tony.Garbarino@harrisgroup.com
AUTOMATION
our difference is engineered...
PROGRAM/PROJECT
MANAGEMENT
500 Airport Blvd., Suite 100 • Burlingame, CA 94010
Toll-Free (888) 242-0559 • Office (650) 320-1788
www.propharmagroup.com
PROCESS DESIGN
COMPLIANCE
CIP/SIP
CORE LAB
855.411.HYDE • HYDE-EC.COM
ISPE SF Board of Directors and Committees
President:
Simon Forder, Hyde Engineering + Consulting
simon.forder@hyde-ec.com
(415) 748-8753
Vice President: Karl Wilks, Foster Wheeler USA
Karl.Wilks@fwc.com
(925) 256-2010
Treasurer:
Ralf Elsaesser, Dome Construction
ralf@domeconst.com
(650) 416-5770
Secretary:
Patti Larson, XL Construction
plarson@xlconstruction.com
(408) 240-6089
Directors
Trevor Auer, CRB Consulting Engineers, trevor.auer@crbusa.com
Tareq Barakzoy, ACCO Engineered Systems, tbarakzoy@accoes.com
Jason Beck, Alexandria Real Estate Equities, jbeck@are.com
Heather Bennett, ACCO Engineered Systems, hbennett@accoes.com
Marlene Meza, Grifols, meza_marlene12@sbcglobal.net
Ulrike Ruppelt, ticular - Strategies For Success, ulrike.ruppelt@ticular.com
Brian Vaughn, CRB, brian.vaughn@crbusa.com
Chapter Past Presidents:
David Bendet, Perkins+Will, 2014
Ian Larson, TRUINJECT 2013
Kelly Keen, Genentech 2012
Corey Veverka, TVS, Inc. 2011
Linda Karr, Genentech 2010
Greg Banks, Banks Integration Group 2009
John Kelley, Genentech 2008
Rob Lynch, Dome Construction Corp. 2007
Mark Hannon, Genentech 2006
Greg Burg, Genentech 2005
Melody Spradlin, Apple 2004
Ed Shea, Currie & Brown 2003 and 2004
Jon Sheh, Johnson & Johnson 2002
Scott Laskey 2001
Haleh Banisadr-Hughes, TVS, Inc. 2000
Jeff Hargroves, ProPharma Group 1999
Sue Cost, Harris Group Inc. 1998
John Sugerik, JTS Enterprises 1997
Dennis Mosher, Bay-Tec (retired) 1996
Ian MacLaren, Southland Industries 1995
Pete McArthur, Amylin (retired) 1994
Burt Van Loon 1993
Program Committee
Chair: Jason Beck, Alexandria Real Estate Equities
Volunteers:
Anthony Bonifacio, PMA
Michael Cooper, BioMarin
Sue Cost, Harris Group Inc.
Leroy Ginn, ACCO Engineered Systems
Rick Ginn, XL Construction
Wei Huang, Newa Technologies
Logan Kelley, BioMarin
Jim Redenbarger, BioMarin
Nathan Temple, Commissioning Agents Inc.
Brian Vaughn, CRB
Commuter Conference Committee
Chair: Ulrike Ruppelt, ticular - Strategies for Success
Volunteers:
Ashley Ching, Delta Project Management
Jack Commins, Clipper Controls
Raffy Espiritu, Impec Group
Teresa Johnk, ProPharma Group
Harvey Steinhaus, Dome Construction
Stacy Stocki, Parker Domnick Hunter
Young Professionals/Student Affairs Committee
Chair: Marlene Meza, Grifols
Volunteers:
Nick Armstrong, Genentech
Heather Bennett, ACCO Engineered Systems
Fion Cheng, Novartis
Bill Chestnut, Independent Consultant
Stacey Cox, Banks Integration Group
David Mourra, Bayer Technology Services
Triet Nguyen, Bayer Technology Services
Bill VanDerVoort, DST Controls
Steve Walker
Faculty:
Jim DeKloe, Solano College
Claire Komives, San Jose State University
Dr. Dorian Liepmann, UC Berkeley
Dr. Karen McDonald, UC Davis
Community Relations
Chair: Heather Bennett, ACCO Engineered Systems
Volunteers:
Charlie Allnutt, DPR Construction
Grace Choi, CRB
Jason Everett, SJSU
Charity Committee
Chair: Ed Shea, Currie & Brown
Volunteers:
Greg Burg, Genentech
Sue Cost, Harris Group Inc.
Volunteer Appreciation Committee
Chair: Kelly Keen, Genentech
Volunteer:
Corey Veverka, TVS
Vendor Night Committee
Chair: Brian Vaughn, CRB
Volunteers:
Heather Bennett, ACCO Engineered Systems
Natasha Masand, Gilead
Kenneth Ng, Genentech
Meriber Ramos, Foster Wheeler Biokinetics
Sokhorn Yim, Genentech
Membership Committee
Chair: Tareq Barakzoy, ACCO Engineered Systems
Volunteers:
Mike Britting, D.F. Pray
Dave Edgar, Iron Construction
Terrence McCarthy, HDR Science & Technology
Edda Mihaescu, PhD, Bayer HealthCare LLC
Cynthia Wiggins, VERSA Engineering/Technology
Fun Day Committee
Chairs: Trevor Auer, CRB
Volunteers:
Arnold Asuncion, Total Validation Services
Mike Britting, D.F. Pray
Dave Edgar, Iron Construction
Claudia Folzman, Iron Construction
Edda Mihaescu, PhD, Bayer Healthcare
Kevin Norman, DES Architects & Engineers
Ravi Shankar, Endress & Hauser
Newsletter/Web Site Committee
Chair: Sandra Medlin, Sani-Tech West
Volunteers:
Jane Adams, Quality and Regulatory Compliance Consultants
Vamshi Gangupomu, PhD, TVS Inc.
Advisory Council
Chair: Sue Cost, Harris Group
Council Members:
Jane Adams, Quality and Regulatory Compliance Consultants
Carl Albertson, Novartis Pharmaceuticals
Mike Batie, Bayer HealthCare Pharmaceuticals
Paul Bezy, Genentech
Joerg Blaesing, Bayer HealthCare Pharmaceuticals
Rob Cone, BioMarin
Kay Cowen, Bayer HealthCare Pharmaceuticals
Al Dadson, XOMA
Al DeGroot, Gilead Sciences
Scott Donald, Grifols/Novartis
Scott Foell, BioMarin
Ross Graves, CRBE
Matt Gray, BioMarin
Dave Hengel, Genentech
David Huff, Genentech
Stephen Johnson, SR Johnson Consulting
Drew Johnston, Bayer HealthCare Pharmaceuticals
Paul Lauer, BioMarin
Binh Le, Gilead Sciences
Alex Lee, Impax Laboratories
Andy Lorenc, Grifols/Novartis
Steve Sharon, Genentech
Joe Tarantino, Novartis Pharmaceuticals
Liaisons (ISPE Past Presidents):
Greg Banks, Banks Integration Group, Inc.
Greg Burg, Genentech
Linda Karr, Genentech
Kelly Keen, Genentech
John Kelley, Genentech
Ian Larson, TRUINJECT
Rob Lynch, Dome Construction Corp
Corey Veverka, TVS, Inc.
Published by ISPE San Francisco/Bay Area Chapter
Serving Northern California
Newsletter Chair: Sandra Medlin, Sani-Tech West
Editor: Kimberly Syre
Email: ksyre@cox.net
Phone: 946.387.9046
NEWSLETTER INVOICE
Circulation: 3900+ / Newsletters Published Nearly Every Month
Company:___________________________________
Contact:__________________________________
Phone #:___________________________________
Fax #:__________________________________
Contact Email Address:_________________________________________________
Thank you for your support of the San Francisco/Bay Area Chapter of ISPE through your advertisements in the Chapter
newsletter. If you are interested in advertising in the future, make sure you fax this form back to us ASAP indicating how
many issues you would like to advertise in along with your credit card payment. To pay by check, please submit this
invoice to your accounting department for payment. All ads are Business card-size, see last page of this document for
instructions on how to submit your artwork. Only pre-paid ads will be placed.
COST PER ISSUE: $100
COST PER YEAR: $840
WE WOULD LIKE TO ORDER ONE YEAR OF ADVERTISING
$
WE WOULD LIKE TO ORDER ___________ ADS
$
840.00
(Please fill in amount to be charged based on the number of ads you would like to order)
When your payment and artwork is received, your ad(s) will be placed in the next newsletter(s) that are published.
All ads can be full color. Newsletters are distributed via email to members and non-members. They are also
available for download from the Chapter’s web site.
❑
❑
❑
VISA
MasterCard
AMEX
If paying by credit card, please indicate which:
Name on Credit Card:__________________________________________________________________
Exp. Date:___________________________________________________________________________
Card #:______________________________________________________________________________
Signature:____________________________________________________________________________
Please make your check payable to: ISPE San Francisco/Bay Area Chapter (Tax ID#68-0282494) and send it to:
5319 University Dr., Suite 641, Irvine, CA 92612
Should you have any questions, please call Attention To Detail at 949-387-9046 or
Fax to: 949-266-8461
www.ispe.org/greaterla
QUARTERLY NEWSLETTER INVOICE
Circulation: 2800+
Name:
Company:
Phone:
Fax:
Email:
Thank you for your interest in advertising in the ISPE Greater Los Angeles Chapter newsletter. Should you decide to
advertise, please fax this form back to us indicating how many issues you would like to advertise in and include your credit
card payment or submit the invoice to your accounting department for payment. All ads are Business card-size (see last
page of this document for instructions on how to submit your artwork and for dimensions). Only pre-paid ads will be
placed.
$
$
500.00
Name on Credit Card:
Card #:
❑
VISA
❑ MasterCard
❑ AMEX
Signature:
Exp. Date:
REMITTANCE ADDRESS - Make Checks Payable to ISPE Greater Los Angeles Chapter
then mail to: 5319 University Dr., Suite 641, Irvine, CA 92612
Should you have any questions, please email Kimberly Syre: ksyre@cox.net
or call Attention To Detail at 949-387-9046 or Fax to: 949-266-8461
ISPE GREATER LOS ANGELES TAX I.D. #95-4452996.
INVOICE
QUARTERLY NEWSLETTER ADVERTISING
Circulation: 2200+
Company:
_____________________________
Contact Phone _____________________________
Contact Name: _____________________________
Contact Fax:
_____________________________
Contact Email: _____________________________
Thank you for your support of the San Diego Chapter of the ISPE through your advertisements in the Chapter newsletter.
If you are interested in advertising in future issues, please fax this form back to us indicating how many issues you would
like to reserve along with your credit card payment. To pay by check, please submit it to your accounting department for
payment. All ads are Business card-size, see last page of this document for instructions on how to submit your artwork.
Only pre-paid ads will be placed.
$
$
500.00
❑
VISA
❑ MasterCard ❑ AMEX
Name on Credit Card: ________________________________ Signature: ______________________________
Card #: ___________________________________________________________Exp. Date: ________________
ALL CHECKS SHOULD BE MADE PAYABLE TO ISPE SAN DIEGO CHAPTER AND SENT (WITH ARTWORK) TO 5319
University Dr., Suite 641, Irvine, CA 92612
Should you have any questions, please email Kimberly Syre: ksyre@cox.net
or call Attention To Detail at 949-387-9046 or Fax to: 949-266-8461.
ISPE SAN DIEGO CHAPTER TAX ID#33-0551783
ISPE West Coast Chapter Newsletter
Artwork Requirements
AD SIZE:
Business Card
3.5” wide x 2” tall
SENDING YOUR ARTWORK
Please email your ad to Kimberly Syre:
ksyre@cox.net
ARTWORK FORMAT
We need two items from each advertiser:
1. Business Card Ad
Preferred graphic format is High Quality pdf Files.
2. Your Company Logo
Make sure to send us a high quality logo in jpeg format
All ads can be full color.
Your ad will only look as good as the artwork you supply. High quality artwork is necessary for high
output quality.