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
March 2012 • Number 2
MIDWEST CHAPTER
extended education & vendor day;
annual golf outing
st. charles, mo • 16 & 17 May 2012
The ISPE Midwest Chapter is holding its annual
Vendor & Extended Education Day at the St.
Charles Convention Center, St. Charles, Missouri,
on May 16th followed by a golf outing the next
morning at Missouri Bluffs Golf Course in St.
Charles. The registration form for both the
Education/Vendor Event and the Golf outing is
posted in this newsletter and also on the Midwest
Chapter Web site.
The education event will include a number of
compelling technical presentations as well as vendor exhibitor tables so please plan to join us at this
year's event. The presentations will include:
Keith Gibbs, from ISPE's Project Management
Community of Practice, will present "Real World
of Project Management". Keith Co-chairs the
Project Management Community of Practice.
Bob Beall, ProPharma Group, will present "Using
a Stage Gate Approach for Technical Transfers and
Associated Case Studies". Bob is the Assistant
Director of Technology Transfer at ProPharma
Group, and has 25 years of industry experience,
including 14 years at Boehringer Ingelheim. Bob is
a TQM facilitator.
Gary Smith of Covidien will be speaking on
"Operational Excellence". Gary is currently business manager for the Contrast Media line of products. During his 17 years in the industry, Gary has
held various roles in manufacturing, quality con-
trol, project management, and operational excellence. Gary will give an overview of Continuous
Improvement Programs and approaches along
with an example of how Lean Six Sigma can be
applied in a Transactional Area (non-manufacturing) work environment.
Lial Tischler, an environmental engineer from
Tischler/Kocurek, will present "Pharmaceuticals
in the Environment", which has become a growing concern for the EPA. Lial is a partner in the
firm based in Austin, Texas. Tischler has over 40
years of experience in industrial wastewater treatment and water quality analysis. He is a technical consultant to the Pharmaceutical Research
Manufacturers of America and assists many major
pharmaceutical manufacturers with regulatory
wastewater management issues.
The presentations will run sequentially so attendees will have the opportunity to attend all four.
The event includes a hot lunch buffet and a networking cocktail hour upon completion of the presentations.
For those who need overnight hotel accommodations, The Embassy Suites St. Charles at 2
Convention Center Plaza, St. Charles MO 633032153 has given us a rate of $139 per night. Call
(636) 946-5544 and tell the clerk that you are with
ISPE Midwest Chapter.
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
Jason Robertson
Past President
CRB Engineers & Builders
816-880-9800
Board members
Tim Alsin
QSPEC Solutions
913-403-0988
Beth Brock
Eli Lilly
913-310-7912
Jim Kolbet
ProPharma Group
913-661-1662 x105
Message
from the President
Brian Beck
Greetings!
Hello to all ISPE Midwest Chapter members. The year is rushing past us, and
we have held two events already. I want to thank all of you who attended
the events in Chesterfield and Ames. The Chesterfield event included a presentation on Master Planning by Jeff Rozelle of CRB and Eric Danielson of
Treanor Architechs and was a very successful dinner event. The event in
Ames included a tour of the USDA NADC facility and a presentation by Dr.
Christian Newcomer, Executive Director of AAALAC. The Tour of the USDA
facility and the presentation by AAALAC were very popular as evidenced
by our high attendance level…we had only one seat left on the bus! Thanks
to all of you that attended both of these events, and a particularly hearty
“Thank You!” to CRB and QSPEC, to everyone at the USDA facility, and to Dr.
Newcomer for their work and support.
Although a couple of events are already on the books, we have more exciting
events planned yet this year, and I hope all of our members can make it to at
least one event. In May, we have the Extended Education Day scheduled in St.
Louis, and that is accompanied with a day of golf as well. A number of excellent tracks are planned, and we will have a good number of vendors available
as well to talk with. In June we are planning a dinner in the Omaha area, and
we have more dinner/golf events planned for August in Minnesota and for
Springfield in September. Other events are being considered for later in the
year as well.
Please see the Vice President’s message in this newsletter for more details on
upcoming events. More information will come in future issues for the events
later in the year.
Again, thanks to all of our members for your support of these events and the
Chapter in general. We are always looking for feedback, so if you have any
questions or comments, please send them to our Chapter Manager, Chris
Clarke, at ispemw@aol.com.
Best Regards, Brian Beck, President
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.masy.com
2
Midwest Chapter
Programs
Kevin Haugh
extended education & vendor day; annual golf outing
Continued from front page
Bluffs was designed by Tom Fazio. The course
length from the Championship Tees is 7,047 yards.
Vendors will be able to purchase their own foursome. The purchase of two foursomes will include
a hole sponsorship. This process is designed to let
vendors choose who they play with. It will be up
to the vendors to invite those people. If a vendor
only registers himself, he may find himself playing
with three other vendors.
Vendor Table set up is on the morning of the event
at 6:00 AM. If a Vendor requires electricity, shipping or storage, go to the Midwest Chapter Web
site at http://www.ispe.org/midwest-chapter and
click the Extended Education Day notice. Forms to
request support are located there. As usual, ISPE
Tabletop Display Rules apply. All displays must be
on top of the table and not on the side or rear of
the table.
Registration begins at 7:00 AM and the Shotgun
Start is at 8:00 AM. Following the golf, we will
have lunch and award the various prizes.
There are several sponsorship opportunities,
including: beer cart, hole prize and lunch sponsor.
Please send in your payment forms by May 4th.
annual golf outing
On May 17, the Midwest Chapter returns to the
popular Missouri Blufs Golf Club at 18 Research
Park Circle, St. Charles MO 63304-5624. Missouri
www.treanorarchitects.com
www.propharmagroup.com
www.SterisLifeSciences.com
www.fike.com
3
Dinner Event at La Vista, Nebraska
on June 7, 2012
Benefits of EM
Sterility, Product Quality, Product
The Midwest Chapter will sponsor a dinner event
at the Embassy Suites in La Vista, NE on June 7.
Krishna Bell of Acumen Technology will make
a presentation on Navigating an Environmental
Monitoring Program within USDA Jurisdiction.
Protection=Patient Protection
Equipment and Room Diagnostic Tool
Tech/Personnel Training/Evaluation Tool
This presentation is oriented towards Animal
Health Companies.
Implementation
Setting Long Term Goals
Determining Specific Needs
Build-up vs. Real-time from the start
Data management
Below is an outline of the topics and issues she
will cover:
Current Regulation under USDA vs. GMP
or FDA Proactive vs. Reactive Approach
The registration form for this event will be sent out
in April.
sales@vaisala.com
www.vaisala.com/lifescience
jason.robertson@crbusa.com
GBATeam.com
www.crbusa.com
sales@qspec.com
www.QSPEC.com
4
www.HEMCOcorp.com
Minnesota Summer Dinner Event and Golf
Clean Room Ceiling Systems Engineered Air will
provide an educational presentation on design
and specification of Clean Room Ceilings. This
presentation will cover clean room ceiling performance criteria, clean room ceiling types, clean
room ceiling construction challenges, clean room
operational challenges, welded vs stick built
performance, pulling it all together, and product
details.
Paul, Minnesota. Our Minnesota dinner event
was held there last year, and due to the overwhelmingly positive feedback, we have decided
to return to the same venue. Started in the space
of an old truck parts store, Summit Brewing
Company has grown to be one of the Midwest’s
favorite beer companies with a unique culture
and team you will love to meet. Check out their
website at www.summitbrewing.com.
The location for the Minnesota dinner and presentation will be at the Summit Brewery in St.
www.custom-powder.com
www.integratedcontainmentsystems.com
David.Shenberger@CAgents.com
www.commissioningagents.com
sales@dciinc.com
www.dciinc.com
www.cgmpvalidation.com
astropak.com
www.burnsmcd.com/pharma
5
ispe international Events
MIDWEST CHAPTER EVENTS
1-3 May 2012
INTERPHEX New York, NY
May 16 & 17
Education & Vendor Day
& Golf Outing
St. Louis, MO
4-5 June
Redefining the "C" in CGMP
Baltimore, MD
june 7
Dinner Event
La Vista, NE
4-7 June
Baltimore Training
Baltimore, MD
august 23 & 24
Dinner Event & Golf Outing
St. Paul & Coon Rapids, MN
6-7 June
Pharmaceutical Supply Networks
Baltimore, MD
SEPTEMBER 24 & 25
Golf Outing & Training Event
Springfield, MO
11-14 November 2012
Annual Meeting, San Francisco, CA
october
Dinner Event
Kansas City, MO
dhaney@meco.com
www.meco.com
www.crbusa.com
www.gbabuilders.com
www.ge-mcs.com/en/validation-and-environmental-monitoring.html
steve.scholtz@ge.com
rmoore@gbabuilders.com
6
scenes from the
AMES, IOWA, DINNER
Social Hour
Dinner buffet at Hickory's Hall
l; Christian Newcomer, AAALAC speaker
Social Hour
www.reesscientific.com
jwynn@muel.com
7
Mail or Fax Your Registration with Payment by May 4, 2012 to:
Chris Clarke, Midwest Chapter Manager • 8601 NW Overland Dr. • Kansas City, MO 64154
FAX: (816) 746-1989 Phone: (816) 741-9484 • E-mail: ispemw@aol.com
Extended Education
& Vendor Day
Golf Outing
May 16, 2012
Registration Fees
May 17, 2012
Registration Fees
PriceQuantity Total
Foursome
PriceQuantity Total
$550
x______ = $______
$140
x______ = $______
$80
x______ = $______
Individual
Non-Members
$100
x______ = $______
Hole Prize Sponsor $200
x______
= $______
Join ISPE*
$320
x______ = $______
Beer Cart Sponsor $500
x______
= $______
Students
$10
x______
= $______
Lunch Sponsor
x______
= $______
Social Hour Sponsor $300
x______
= $______
Lunch Sponsor
$250
x______
= $______
VendorTable
$600
x______
= $______
Members
(Includes two people with table)
Total Amount
$_____________
Payment Method
❒ Check enclosed—payable to ISPE Midwest Chapter
❒ Bill my Credit Card—Circle Type: VISA M/C AMEX
*Attend the event and join ISPE
Total Amount
$300
Name____________________________________________
$_____________
Card #___________________________________________
Payment Method
❒ Check enclosed—payable to ISPE Midwest Chapter
Expiration Date____________________________________
❒ Bill my Credit Card—Circle Type: VISA M/C AMEX
Signature_________________________________________
Name____________________________________________
Card #___________________________________________
ISPE Membership #________________________________
Expiration Date____________________________________
Name____________________________________________
Signature_________________________________________
Company_________________________________________
ISPE Membership #________________________________
Name____________________________________________
Address__________________________________________
Company_________________________________________
City/State/Zip______________________________________
Address__________________________________________
City/State/Zip______________________________________
Phone___________________________________________
Phone___________________________________________
Fax______________________________________________
Fax______________________________________________
E-mail___________________________________________
E-mail___________________________________________
8