Nanc
Published by the ISPE PNW Chapter
Serving Washington and Oregon
Editor: Katie Bohocky: aminc2@comcast.net
Ph 1.877.460.5880 Fax 1.253.265.3043
IN THIS ISSUE
April 25 Event
PAGE 1
Welcome New Members
PAGE 1
April Anniversaries
PAGE 2
President’s Message
PAGE 2
Upcoming Events
PAGE 2
Feature Member Benefit
PAGE 2
Advertise with ISPE
PAGE 3
Communities of Practice
PAGE 3
APRIL 2013 NEWSLETTER
Our Disposable Technologies - Lessons Learned Event!
Thursday, April 25, 2013
Join us April 25th for a discussion about the lessons learned
from implementing disposable technologies.
Speakers:
Christopher S Miles, Bioprocess Specialist, Foster Wheeler Biokinetics, Inc.
Chris Thomas, Validation Cleaning ProgramManager, CMC Biologics
Location:
Harris Group
Holland America Building, 300 Elliott Ave. W, Suite 500, Seattle, WA 98119
Click here for directions
Agenda:
4:45 - 5:30 - Networking, Drinks, Appetizers, and Registration
5:30 - 6:30 - "Disposable Technology - Lessons Learned"
6:30 - 6:45 - Q&A and networking
Appetizers and drinks will be provided!
Cost: $20/ ISPE Members / $40/ Non-Members
FREE for Students & 1st time guests of an ISPE PNW Chapter event!
Register: Click here to register today!
2013 Classroom Training
PAGE 3
Thanks to our Sponsor!
News from International
PAGE 4
Welcome New Members!
__________________________________
Matt G. Fetcho, Jubilant HollisterStier
Gil Haubert, Jubilant HollisterStier
Joseph Tremblay, McKinstry Co., LLC
Tim Wagner, Jubilant HollisterStier
Submit Your
Articles!
Click here to submit
your articles for next
month’s Newsletter.
All suggestions will be
reviewed by the Board of
Directors.

 198 active members as of April 3.
ISPE PNW – Serving the biopharmaceutical industy since the
mid-nineties.
ISP E P ACI FI C NO RTHW E ST CH AP TE R
NEW SL E TTE R April 2013
PAGE 1
Our April Anniversaries!
21 Years - Tab Bronson
12 Years - Jeroen Immerzeel
10 Years - Chris H. Sterzinger, MBA
6 Years - Robert E. Munday, Jr. & David M. Perry
5 Years - Craig T. Grass & Debra A. Katter
4 Years - Angela Bazigos
2 Years - Rebecca Moore
1 Year - David Giordano, P.E., S.E., Kristina
Jackson, Yi Fan Shi, David A. Anderson, Kate M.
Gottry, Andrew E. Russell, Michael Overfield
and Roy A. Musil
President’s Message
by Erik Westover
Following the success of our Georgetown
Brewery Tour the PNW ISPE Chapter has been
busy planning events for the rest of the year. We
are working on two great events coming in April
and May. We are focusing the April event on a
disposable technology lessons learned. We look
forward to talking with all of you about the latest
technology. We will have a variety of vendors,
facility groups and users of this equipment at the
discussion and invite others to join in sharing your
information. Click here to register to attend our
April event.
We still have several openings for commuter
conference topics in June and in the Fall, please
feel free to submit them to the Association Office
for review by the Board of Directors.
Finally, registration for the ISPE Golf Tournament
is open! This will be held on July 19 with a 2pm
afternoon start. So get your 4-some scheduled
and click here to sign up to play today!
________________________________
Featured Member Benefit
Networking
with
professionals!
dedicated
ISPE offers some of the best networking opportunities
you will find in the industry. Whether it's through our
extensive international network of Affiliate and
Chapters, our discipline-specific Communities of
Practice, volunteering on ISPE initiatives or at
dedicated networking events at ISPE conferences,
ISPE is your gateway to connecting with the top
technical minds in your region and all over the world.
Learn more
Join a Committee!
Your Board of Directors needs your help. Contact the
Association office at aminc2@comcast.net if you are
interested in joining a committee!
Upcoming Events!
Thursday, May 23 - "State of the Art
Manufacturing Facilities and Equipment"
Friday, July 19, 2013 - Annual Golf Tournament.
Willows Run Golf Course at 2:00pm.
Click here to register to play today!
Event details to follow!
ISP E PA CIF IC NO RT HW E ST CHAP TE R
like-minded
NEW SLET TE R April 2013
PAGE 2
Advertise with the ISPE PNW Chapter!
Newsletter Sponsorships!
ONLY $100 Per Quarter (3 newsletters
per quarter)
or $400 for an Entire Year (12 newsletters)!
It's a great, economical option for your advertising
dollar! Click here for more information!
Website Sponsorships
As a Website Sponsor, your firm's logo will randomly
rotate through six pages of the ISPE PNW Chapter
website for all of 2013!
Cost – ONLY $150 per Ad!
Upcoming Education Opportunites
Contact the Association Office
at aminc2@comcast.net or
Toll Free 1-877-460-5880 to secure your
Newsletter & Website sponsorship today!
ISPE’s Communities of Practice (COPs)
Connect with like-minded pharmaceutical industry
professionals through one of our 19 interactive online
communities offering exclusive global networking
opportunities and access to a community-specific
body of knowledge.
COPs are now only available to ISPE Members. Join
ISPE today to ask questions and share your expertise
in online discussions and access technical articles, ELetters and other valuable resources that will assist
you in increasing your effectiveness.
Click here to join a COP today!
___________________________________________
ISP E PA CIF IC NO RT HW E ST CHAP TE R
NEW SLET TE R April 2013
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NEWS FROM ISPE INTERNATIONAL
ISPE Releases New Guidance for
Standardizing Use of
Booklet Labels in Global Clinical Trials
(TAMPA, FLORIDA, USA, 03 April 2013) – ISPE, a leading
authority on best practices for the pharmaceutical industry,
announced today that it has issued the industry’s first-ever
guidance to help companies conducting clinical trials in
multiple countries standardize their use of booklet labels.
The Guide provides templates, guidelines and tools to make
it easier for companies to use booklet labels consistently
and effectively and justify their booklet label methods to
international regulatory authorities.
“ISPE is pleased to introduce its first Guide to support
harmonization of labeling requirements globally,” said ISPE
President and CEO Nancy S. Berg. “Companies involved in
clinical trials now have a resource that provides guidance
on how to design and structure a booklet label and how to
standardize the use and application of booklet labels for
global clinical trials. By following the recommendations
presented in the Guide, companies can feel confident that
their booklet label strategy is supported by a scientific, riskbased methodology and patients are receiving accurate,
complete instructions in their local language.”
The ISPE Good Practice Guide: Booklet Labels has been
reviewed by MHRA officials, and their feedback has been
incorporated into the Guide’s content. The Guide’s
recommendations will help companies determine the gaps
between their current booklet label procedures and best
practices. It contains resources for training clinical trial
personnel on proper booklet label use and templates that
companies can put into practice immediately to help
improve compliance and cost-effectiveness of their clinical
trials.
The ISPE Good Practice Guide: Booklet Labels is available
for purchase on the ISPE website.
For more information contact:
Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
email: dhould@ispe.org
www.ISPE.org
2013 Facility of the Year Awards (FOYA)
Winners Announced
Sponsored by ISPE, INTERPHEX, and Pharmaceutical
Processing magazine, the Facility of the Year Awards
(FOYA) is an annual program recognizing state-of-the-art
pharmaceutical manufacturing projects that utilize new and
innovative technologies to enhance the delivery of a
superior project, as well as reduce the cost of producing
high-quality medicines. Now in its ninth year, the awards
program effectively demonstrates the accomplishments,
shared commitment, and dedication of individuals in
companies worldwide to innovate and advance
pharmaceutical manufacturing technology for the benefit of
all global consumers.
The winning companies and respective award categories
are:






Biogen Idec, winner of the Facility of the Year
Award for Facility Integration for its Flexible Volume
Manufacturing (FVM) Project in Research Triangle
Park, North Carolina USA.
F. Hoffmann – La Roche, winner of the Facility of
the Year Award for Project Execution for its TR&D –
Building 97 Facility in Basel Switzerland.
MedImmune, winner of the Facility of the Year
Award for Equipment Innovation for its UK
Automation Upgrade Project in Speke, Liverpool UK
Merck & Co., Inc., winner of the Facility of the Year
Award for Operational Excellence for its Vaccine
and Biologics Sterile Facility (VBSF) Project in
Carlow Ireland
Morphotek, Inc., winner of the Facility of the Year
Award for Sustainability for its Morphotek Pilot Plant
in Exton, Pennsylvania USA
Novartis Vaccines and Diagnostics, winner of the
Facility of the Year Award for Process Innovation
for its U.S. Flu Cell Culture Facility in Holly Springs,
North Carolina USA
The International Society for Pharmaceutical Engineering (ISPE) is an international society consisting of over 22,000
members in 90 countries. ISPE facilitates venues for networking, interaction, and information sharing within the region
and provides publications, conferences, and trainings on a wide variety of topics from Good Engineering Practices to
Quality Risk Management. Our membership constituency is made up of professionals from the biotechnology,
pharmaceutical and medical device manufacturers and other supporting industries such as academia, equipment
manufacturers, and construction/architecture.
ISP E PA CIF IC NO RT HW EST CHAP TE R
NEW SLET TE R April 2013
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