NEWSLETTER
Published by the Midwest Area Chapter
Serving Iowa, Kansas, Minnesota, Missouri & Nebraska
Chapter Manager: Chris Clarke Phone: 1.816.741.9484
E-mail: ispemw@aol.com www.ispe.org/midwest
January 2012 • Number 1
MIDWEST CHAPTER dinner events
& plant tour
chesterfield, mo, dinner • 16 feb 2012 &
ames, ia, dinner & plant tour • 8 mar 2012
Chesterfield, MO
February 16, 2012
Dinner
Master Planning for the
Pharmaceutical and Biotech Industry
The first Midwest Chapter Event of the year will be
a dinner event at the Doubletree Hotel & Conference
Center in Chesterfield MO. The event begins with a
happy hour at five o’clock followed by the presentation at six o’clock. An Italian “Hill Buffet” will follow the presentation.
The presentations will be delivered by Eric
Danielson of Treanor Architects and Jeff Rozelle of
CRB Engineers. Eric Danielson is the Director of
Business Development for Treanor Architects. He
works with their Science & Technology division as
a planner and manages pre-design activities. He
is a graduate of the University of San Diego and
the secretary of the Board of Directors of the ISPE
Midwest Chapter. Jeff Rozelle is the Biotech Core
Team Leader for CRB Consulting Engineers in
Kansas City. His diversified experience ranges from
conceptual design through construction focusing on
process and utilities engineering, project management, facility start-up and validation. His education
includes degrees in Chemical Engineering and MBA
from the University of Kansas. He currently serves
on the Board of Directors of the ISPE Midwest
Chapter.
Unless you have a crystal ball in your back pocket,
planning for the future of your operations can be
a daunting task. A master plan, however, can be
the tool that provides a roadmap towards a successful future, but only if it takes comprehensive
view across the entire spectrum of your business.
Through our experience working with the pharmaceutical and biotech industry, we have developed a process that identifies the availability of
existing assets and the forecast for product manufacturing. Once you know this information, a
master plan is a tool to make informed projections
about how your company can get its products in
the hands of its consumers.
To register, fill out the registration
form in the newsletter and fax it with
your credit card information to
Chris Clarke at (816) 746-1989.
Continued on page three
Board of
Directors
Brian Beck
President
Pfizer
402-441-2636
brian.beck@pfizer.com
Kevin Haugh
Vice-President
CRB
816-891-3704
Gregg Stapleton
Treasurer
Control Service Company
816-600-5804
Eric Danielson
Secretary
Treanor Architects
785-843-5554
Message
from the President
Brian Beck
I am writing this article amidst a wonderful stretch of weather here in the
Midwest. Although this winter has not been particularly harsh so far, I am still
anxiously looking forward to Spring. In particular I am very excited about the
upcoming events that the ISPE Midwest Chapter Board has planned.
Two dinner events are being planned in February and March for the Midwest
Chapter. In February we have an excellent event planned in Chesterfield, MO,
and in March we are developing an event that will include a tour of the APHIS
facility in Ames, IA. Both events are sure to be well attended, so please sign
up soon so we can accommodate as many people as possible.
Jason Robertson
Looking further ahead to May, our Extended Education day this year will be
in St. Louis, and a number of informative tracks are being planned, including
Project Management, Tech Transfer, Quality, and Operational Excellence. More
information on upcoming events can be seen in the Vice President's message in
this newsletter.
Board members
I encourage all Chapter members to attend one or more events to take advantage of the excellent programming that’s planned. I also again extend an invitation to all to provide ideas for future events or for feedback on recent events.
If you have any comments, please send them to Chris Clarke at ispemw@aol.
com.
Past President
CRB Engineers & Builders
816-880-9800
Tim Alsin
QSPEC Solutions
913-403-0988
Thanks to all for your continued support of the Chapter, and I sincerely hope
to see you soon.
Best Regards, Brian Beck
President
Beth Brock
Eli Lilly
913-310-7912
Jim Kolbet
ProPharma Group
913-661-1662 x105
Bryan Neisen
Upsher-Smith Laboratories
612-490-2132
Jeff Rozelle
CRB
816-880-9800
Greg Spanel
ProPharma Group
913-661-1662 x109
Gary Westhoff
Steris—Retired
sgwesthoff@sbcglobal.net
www.gbabuilders.com
2
rmoore@gbabuilders.com
Midwest Chapter
Programs
Kevin Haugh
MW DINNERS & PLANT TOUR
To identify the availability of existing assets, our
master planning team takes an in-depth look at
the workforce, existing sites & facilities, manufacturing process, production forecasts and product
development cycle in which it all occurs. To do so,
we set up a series of site visits and interviews with
groups and individuals in the various functional
units of your workforce. Engaging in personnel
interviews at the sites, we question, listen, and
verify the information we receive during tours and
meetings. We gain insight into the manufactured
products, as well as understand the logistics chain
associated with raw material, in-process products, and finished goods. A large volume of data
is gathered during this phase: equipment sizes,
capacities and utilization rates, square footages of
Continued from front page
manufacturing and support space, adjacencies of
the existing operation, utility infrastructure, and
site data, such as land area, utility service, parking, and vehicular and pedestrian circulation. The
interviews cover short and long term sales goals,
and the amount and type of products which need
to be sold to achieve them. While these goals may
already exist our team will lead the team through
a strategic visioning session to better understand
and document your client base and the sales
opportunities associated with it.
Once we obtain, verify, and understand this information that forms the foundation for the master
planning effort, only then can solutions begin to
take form. The master plan is a visual expres-
Continued on page four
dhaney@meco.com
www.meco.com
www.HEMCOcorp.com
astropak.com
GBATeam.com
3
MW DINNERS & PLANT TOUR
Continued from page three
Ames, IA
March 8, 2012
Plant Tour & Dinner
sion of these solutions; it is where the existing and
potentially expanded operational infrastructure is
in alignment with the vision for the future. This
infrastructure is defined as the workforce, equipment, utilities, and building space needed for
the product development cycle. The first recommendation we make is regarding any deficiency
we identify where the projected manufacturing capacity cannot keep up with the projected
demand. Moving forward into the future, we will
make comprehensive recommendations on what
improvements/expansion is necessary to the existing infrastructure in order to achieve those predetermined long and short term goals. Phasing of
functional spaces is a key consideration as existing
operations can often be limited in expandability
and swing space required to achieve efficient and
effective implementation of the master plan.
USDA NADC Facility
The ISPE Midwest Chapter is home to a significant
number of animal health companies. Many of these
companies house animal test facilities for R&D, as
well as product testing. In recognition of this, the
chapter has selected the USDA NADC facility at
Ames, Iowa as the location of our next tour, on
March 8, 2012. NADC is the National Animal
Disease Center, and is focused on research to solve
animal health and food safety problems faced by
livestock producers and the public. Following the
tour, we will have a social hour, and then a dinner presentation at Hickory Park's Hickory Event
Hall. The speaker will be Dr Christian Newcomer,
Executive Director of AAALAC , the Association for
Assessment and Accreditation of Laboratory Animal
Care. AAALAC is an international, non-profit organization that promotes the humane treatment of
animals in science through voluntary accreditation
and assessment programs. AAALAC's voluntary
accreditation process allows research programs to
demonstrate that they meet the minimum standards
required by law, and are
also going the extra step to
achieve excellence in animal
care and use. We hope you
will join us for the tour, presentation, and some delicious
food at Hickory Park!
Master planning for the pharmaceutical and biotech market is essential to ensure your products
can always be in the hands of your consumers
when they need them. Without appropriate and
flexible planning, your company may not be able
to keep up with the demands of a dynamic marketplace. With a master plan in hand, you have
the data, solutions, and confidence about achieving the goals you are making for the future.
The registration form is posted at the end of this
newsletter and also on the
Midwest Chapter website.
There are several sponsorships available to include
dinner, happy hour and
vendor tabletop displays.
Feel free to call the Chapter
Manager, Chris Clarke to
discuss sponsorships.
Image of USDA Facility at Ames:
sales@dciinc.com
www.dciinc.com
www.SterisLifeSciences.com
4
MIDWEST CHAPTER EVENTS
jwynn@muel.com
february 16
Dinner Event
Chesterfield, MO
MARCH 8
Plant Tour & Dinner Event
Ames, IA
COMPLIANCE SERVICES
May 16 & 17
Education & Vendor Day
& Golf Outing
St. Louis, MO
AUTOMATION
VALIDATION
PROGRAM/PROJECT
MANAGEMENT
www.propharmagroup.com
SEPTEMBER 24 & 25
Golf Outing & Training Event
Springfield, MO
www.reesscientific.com
www.fike.com
www.ge-mcs.com/en/validation-and-environmental-monitoring.html
steve.scholtz@ge.com
www.crbusa.com
5
ispe international Events
27-28 February 2012
Lessons from 483s: Enhancing Efficiency,
Quality, and cGMP Compliance
Tampa, Florida
29 February-1 March 2012
Aseptic Conference, Tampa, Florida
David.Shenberger@CAgents.com
www.commissioningagents.com
1-3 May 2012
INTERPHEX New York, NY, NY
www.treanorarchitects.com
jason.robertson@crbusa.com
www.crbusa.com
www.custom-powder.com
www.integratedcontainmentsystems.com
sales@qspec.com
www.QSPEC.com
www.burnsmcd.com/pharma
6
www.masy.com
scenes from the
minneapolis, mn, dinner
Len Powell, Jason Duncan and Ken Blankenship
Social Hour
Social Hour
Evening's Speaker, Mike Valentine of Minntech
sales@vaisala.com
www.vaisala.com/lifescience
www.cgmpvalidation.com
7
ISPE’s Midwest Chapter Dinner event
Chesterfield MO, february 16, 2012
Doubletree Hotel & Conference Center
16625 Swingley Ridge Road, Chesterfield, MO 63017
(636) 532-5000 Fax (636) 530-1149
The theme is Master Planning, presented by Eric Danielson, Director of Business
Development, Life Sciences, at Treanor Architects in Lawrence KS and Jeff Rozelle,
Biotech Core Team Leader for CRB Consulting Engineers in Kansas City, MO.
Proactive planning for the future is critical for the success of any business, but especially in the pharma and biotech market. The creation of a Master Plan for your
business is an all encompassing process that considers manufacturing capacity,
sales forecast, logistics for raw and finished goods and infrastructure demands.
The master planning process dives deep into your business process and acknowledges the inter-dependence of the different units that make up your enterprise.
Once complete, this living document can serve as a road map that will guide you
toward your successful future.
Registration
ISPE Membership #________________________________
Name____________________________________________
Schedule
of Events
5:00 PM
Happy Hour
7:00 PM
Dinner
6:00 PM
Presentation
Registration Fees
PriceQuantity Total
Members
$60
x______ = $______
Non-Members
$85
x______
Address__________________________________________
Join ISPE*
$300
x______ = $______
City/State/Zip______________________________________
Students
$10
x______
= $______
Phone___________________________________________
Social Hour Sponsor $500
x______
= $______
Fax______________________________________________
Dinner Sponsor
$250
x______
= $______
E-mail___________________________________________
VendorTable
$600
x______ = $______
Company_________________________________________
*Attend the event and join ISPE
Additional Attendees
Name
= $______
Total Amount
ISPE # $_____________
Payment Method
1.______________________ _____________
❒ Check enclosed—payable to ISPE Midwest Chapter
2.______________________ _____________ ❒ Bill my Credit Card—Circle Type: VISA M/C AMEX
Mail or Fax Your Registration
with Payment
by February 2, 2012 to:
Name____________________________________________
Card #___________________________________________
Chris Clarke, Midwest Chapter Manager
8601 NW Overland Dr. • Kansas City, MO 64154
Expiration Date____________________________________
FAX: (816) 746-1989 Phone: (816) 741-9484
E-mail: ispemw@aol.com
Signature_________________________________________
8
Everything looked good except I noticed one thing on the registration form. In
the first paragraph it lists Jeff Rozelle as the Biocore Team Leader instead of the
Biotech Core Team Leader. Just a small change but other than that all the writing
looks really good!