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 2013 • Number 1
Technology and Education day
arrowhead stadium, kansas city, mo • 7 may 2013
The tradition of the ISPE Midwest Chapter gathering in
the spring continues in 2013 in Kansas City. Though the
venues have changed from places in St. Louis, Omaha,
and KC, this year’s venue is certainly a memorable one:
Arrowhead Stadium. The recent $375M renovation of
Arrowhead has enabled it to comfortably host events like
ours. Attendees at this year’s event will get a guided
stadium tour. In addition to viewing all the team and fan
amenity spaces, tour groups will also get a chance to see
the engineering systems that serve the stadium.
As in previous years, we anticipate a great turnout of
industry professionals and service providers. Vendors
are welcome and encouraged to showcase their newest
and most innovative products services they are offering to
customers in the market place. End-users depend on this
exhibition to ensure they are achieving the best operational outcomes they are responsible for. Vendors will have
multiple opportunities to connect with these end-users
through programmed events throughout the day.
After engaging the membership and learning what education topics are important to learn more on, three topics
were identified:
• Lean Manufacturing
• Operational Excellence
• Risk-MaPP update
A request for topics was submitted to ISPE Midwest
Chapter members and we received a number of great topics worthy of presentation. The Board of Directors selected four presentations which we are excited to present as
part of the 2013 Education and Vendor Day:
Current trends in Risk management
of Contamination in Pharmaceutical cleanrooms
and critical/controlled environments
Alan Fisher, Business Development Manager and
Contamination Control Specialist at Dycem USA and UK
Alan is a Contamination Control Specialist who has been
involved in advising pharmaceutical manufacturing
operations in the USA, UK, Europe and Asia. He is a sea-
soned and experienced speaker who serves on a number
of Working Committees reporting on ISO standards with
particular responsibility for Risk Management in cleanrooms and controlled/critical environments.
Abstract: What is Contamination; the sources and vectors of contamination and cross contamination; particles,
particle technology and particle movement; all the stages
of risk management (including current European RiskMapp, risk identification, risk analysis, risk evaluation,
risk control, risk reduction, risk review and risk communication); with a particular emphasis on the application of
Risk-Mapp and Risk Management policies in multi-product contract manufacturing pharmaceutical Operations
particularly the impact upon all the stakeholders of
Pharmaceutical Manufacturing Facilities with some simple
suggestions on mitigating these risks.
Schedule of Events
7:30 – 8:00 Check-in and Continental Breakfast
7:30 – 8:40 Vendor Tables Open
8:00 – 8:10 Opening remarks
8:10 – 9:10 Group A Tour of Arrowhead
8:40 – 9:40 Group B Tour of Arrowhead
9:50 – 10:50 “Risk Management of Contamination”
Alan Fisher, Dycem
10:55 – 11:55 “Intersection of cGMP Compliance and Cor-
porate Compliance” Brian Dahl, Propharma
12:00 – 1:30 Lunch and Vendor Tables Open
1:35 – 2:30 “FAT” In Our World Today”
Stig Bockman, ProPharma
2:30 – 3:00 Coffee Break and Vendor Tables Open
3:05 – 4:00 “What is Ops Excepllence and How Do
You Know it When You See it?”
Michael Glavin, Burns & McDonnell
4:00 – 5:30 Social Hour and Vendor Tables Open
Continued on page three
Board of
Directors
Brian Beck
President
Pfizer
402-441-2294
brian.beck@pfizer.com
Eric Danielson
Vice-President
Treanor Architects
785-843-5554
Tim Alsin
Treasurer
QSPEC Solutions
913-403-0988
Jeff Rozelle
Secretary
CRB
816-880-9800
Jason Robertson
Past President
CRB Engineers & Builders
816-880-9800
Board members
Beth Brock
Eli Lilly
913-310-7912
Mike Glasker
GBA
913-577-8815
Message
from the President
Brian Beck
Greetings!
Hello again to all ISPE Midwest Chapter members. Winter is hopefully getting past us soon, and I am anxiously looking forward to Spring and the
events we have coming up. The recent event in St. Louis was a great success,
and we hope to build on that for the rest of the events this year. Thank you
to all who attended that event, and a particular “Thank You” to the sponsors:
Gregg Dougan of Experitec, Dinner Sponsor; Steve Wuennenberg, Johnson
Controls, Social Hour Sponsor; and Carolyn Brown, Laboratory Validation
Specialist, Vendor Table.
Coming soon we have a great event planned for Technology and Education
Day. The event will be held at Arrowhead Stadium in Kansas City on May 7.
See the cover story of this newsletter for all of the details. Please plan to
attend this event, but be sure to sign up early as this is sure to be very popular.
I look forward to seeing everyone there.
The rest of 2013 will be busy as well, and will include golf outings as well
as dinner events planned to be held in Minnesota, Springfield, MO, and
Nebraska. More information will be sent out on these events as the plans are
firmed up so keep an eye on your email.
Again, thanks to all of our members for your support of these events and for
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, ISPE Midwest Chapter
Jim Kolbet
ProPharma Group
913-661-1662 x105
Bryan Neisen
Upsher-Smith Laboratories
763-315-2667
Jeff Rozelle
CRB
816-880-9800
Greg Spanel
ProPharma Group
913-661-1662 x109
sales@qspec.com
www.QSPEC.com
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Midwest Chapter
Programs
Eric Danielson
Technology and Education day
The Intersection of cGMP Compliance
and Corporate Compliance
Continued from front page
ects and improve the FAT planning, execution and quality
to support qualification.
“What is Ops Excellence and How Do You
Know It When You See It?”
Brian Dahl, Senior Director and Practice Lead of ProPharma
Group’s Corporate Ethics & Compliance Practice
Brian is a frequent speaker on Corporate Compliance
topics at conferences throughout the country, including most recently speaking on the topic of the impact of
the Physician Payment Sunshine Act on pharmaceutical
company financial arrangements with healthcare professionals and what companies should be doing in advance
of disclosure of payments made in connection with such
arrangements to minimize scrutiny of those arrangements
under laws like the federal False Claims Act and AntiKickback Statute.
Michael Glavin, Project Manager, Burns & McDonnell
Michael has 20+ years of experience in Lean and is an accomplished presenter and trainer.
Abstract: data. Metrics are a key part of your business,
and we all agree that metrics drive behavior. But how do
you know if your metrics are well aligned to what your
customers actually want and to the strategic direction of
your business? We will demonstrate the use of a tool that
visually depicts the strength of the association between
stakeholder/customer values, your strategic objectives,
your key processes and key metrics. The outcome of the
analysis gives the user an indication of how well their
organization is “designed” to deliver customer value and
business success, and where they have misalignment.
With this understanding, the organization can apply Lean
Thinking to close the gap, improve the bottom line and
promote customer satisfaction.
Learning Objective: Understand how the recent foray
by the Office of Inspector General (OIG) into GMP
Compliance as part of the GlaxoSmithKline Corporate
Integrity Agreement (CIA) may impact the future of GMP
Compliance.
“FAT” In Our World Today
Stig Bockman-Pedersen, Associate Director SE Region,
ProPharma Group, Inc.
The Attendee Registration Form is attached to this newsletter and the Vendor Registration Form is posted on
the Midwest Chapter website at http://www.ispe.org/
midwest-chapter. Please fill out the forms and send with
payment to our Chapter Manager, Chris Clarke.
Stig has worked in the pharmaceutical/biotech industry
for 24 years. He has served as Validation Project Manager,
Director of Validation both as a consultant and within
industry specializing in C&Q and is a specialist in ASTM
2500 ways of working. He is also a specialist in planning,
writing and executing FATs to save schedule time using a
proven proprietary planning system.
When you get to the stadium, go all the way to the back
and park in parking lot E. You will enter the stadium
through the Tower Gate.
Learning Objective: Learn ideas to make FATs more
practical and cost effective for CapEx or replacement proj-
For more information, please contact Chris Clarke at (816)
741-9484 or at ispemw@aol.com.
www.geinstruments.com/cv
www.gbabuilders.com
3
rmoore@gbabuilders.com
Annual Spring Golf Outing
The Annual Spring Golf Outing is coming back to the Kansas City area after a four year
absence. We will have our golf scramble at Drumm Farm Golf Club in Independence MO
on June 6.
The day’s events will include a box lunch, a shotgun start scramble followed by a BBQ
Dinner and an awards ceremony.
We are looking for corporate hole prize sponsors as well as Beer Cart, Box Lunch and
Dinner Sponsors. Your contributions help make our Chapter Events so successful.
The registration form is attached to this newsletter. Please send your forms with payment
to Chris Clarke, Chapter Manager.
ispe international Events
www.propharmagroup.com
St. Louis, Missouri Training
20-23 May 2013
3-6 November 2013
ISPE Annual Meeting
Washington, DC
www.custom-powder.com
www.integratedcontainmentsystems.com
GBATeam.com
David.Shenberger@CAgents.com
www.commissioningagents.com
4
www.cgmpvalidation.com
astropak.com
sixlog.com
jwynn@paulmueller.com
MIDWEST CHAPTER EVENTS
June 6
Golf Outing, Drumm Farm GC
Independence, MO
August
Golf Outing/Dinner Event
Minneapolis, MN
September 23 & 24
Golf Outing & Training Event
Springfield, MO
www.masy.com
www.HEMCOcorp.com
sales@dciinc.com
www.dciinc.com
5
2013 Classroom
Training
ISPE’s in-depth courses cover the entire
product lifecycle and are led by instructors
who are active in the industry.
Newton, Massachusetts USA
(Boston Area)
8 – 11 April
• Biopharmaceutical Facilities (T31)
• HVAC for Pharmaceutical Facilities (T14)
• Overview of Biomanufacturing
Processes (T24)
• Pharmaceutical Water Generation (T04)
• Q7A: Implementing Good Manufacturing
Practices (T30)
• Sterile Drug Manufacturing Facility (T12)
• Storage, Delivery and Qualification of
Pharmaceutical Waters (T23)
San Francisco, California USA
10 – 11 April
• Risk-MaPP (T41)
• Process Validation in Biotechnology
Manufacturing (T32)
• Process Validation in Biotechnology
Manufacturing (T32)
• Q7A: Implementing Good Manufacturing
Practices (T30)
• HVAC for Pharmaceutical Facilities (T14)
Indianapolis, Indiana USA
13 – 15 May
• GAMP® 5 Process Control Systems (T21)
• Sterile Drug Manufacturing Facilities (T12)
• Auditing for GMP (G07)
• Oral Solid Dosage (T10)
Register Early and Save!
www.ISPE.org/Training
jason.robertson@crbusa.com
www.crbusa.com
www.reesscientific.com
www.ddkscientific.com
www.treanorarchitects.com
6
scenes from THE ST. LOUIS Dinner EVENT
Social Hour
Social Hour
Social Hour
dhaney@meco.com
www.burnsmcd.com/pharma
www.meco.com
www.ge-mcs.com/en/validation-and-environmental-monitoring.html
steve.scholtz@ge.com
www.fike.com
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ISPE’s Midwest Chapter
Technology & Education DAY 7 may 2013
ARROWHEAD STADIUM, One Arrowhead Drive, KANSAS CITY, MO
schedule of events
registration
Registration Fees
7:30am—8:00Check-in
q YES, I Do Want to go on the Arrowhead Tour
7:30—9:40 Vendor Tables Open
8:00—8:10 Opening remarks
8:10—9:10 Group A Tour of Arrowhead
8:40—9:40 Group B Tour of Arrowhead
10:55—11:55 “Intersection of cGMP Compliance &
Corporate Compliance”, Brian Dahl,
Propharma
12:00—1:30pmLunch and Vendor Tables Open
1:35—2:30 “FAT” In Our World Today”, Stig Bockman, ProPharma
Total
Non-Members
$100 x______ = $______
Join ISPE*
$340 x______ = $______
Students
$10 x______
= $______
Social Hour Sponsor
$400 x______
= $______
Lunch Sponsor
$300 x______
= $______
$70 x______ = $______
VendorTable—get registration form at
http://www.ispe.org/midwest-chapter
*Attend the event and join ISPE
Total Amount
$_____________
2:30—3:00 Coffee Break and Vendor Tables Open
3:05—4:00 “What is Ops Excellence and How Do You Know it When You See it?”, Michael
Glavin, Burns & McDonnell
PriceQuantity
Members
9:50—10:50 “Risk Management of Contamination”,
Alan Fisher, Dycem
Payment Method
4:00—5:30 Social Hour and Vendor Tables Open
q Check enclosed—payable to ISPE Midwest Chapter
q Bill my Credit Card—Circle Type: VISA M/C AMEX
Name____________________________________________
Card #___________________________________________
Expiration Date____________________________________
Overnight Hotel Reservations
Signature_________________________________________
Rooms are available at the Drury Inn,
3830 Blue Ridge Cutoff, Kansas City, MO.
Call 1-800-378-7946 to make your reservation.
ISPE Membership #________________________________
Name____________________________________________
Company_________________________________________
Parking and Entering the Stadium
Park in Parking Lot E at the south end of the stadium
and enter through the Tower Gate.
Address__________________________________________
Mail or Fax Your Registration
with Payment by 29 APR 2013 to:
Phone___________________________________________
Chris Clarke, Midwest Chapter Manager
8601 NW Overland Dr. • Kansas City, MO 64154
E-mail___________________________________________
FAX: (816) 746-1989 Phone: (816) 741-9484
E-mail: ispemw@aol.com
City/State/Zip______________________________________
Fax______________________________________________
Additional Attendees
Name
ISPE # 1.______________________ _____________
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ISPE’s Midwest Chapter
GOLF OUTING—6 june 2013
Drumm Farm Golf Club
registration
15400 East 34th Street
Independence, MO 64055
schedule of events
Registration & Box Lunch
11:00 AM
Shotgun Start
12:30 PM
BBQ Dinner and Awards
Registration Fees
5:30 PM
PriceQuantity
Total
Foursome
$400 x______ = $______
Individual
$100 x______ = $______
Prize Hole
$100 x______ = $______
Beer Cart
$300 x______
= $______
Lunch Sponsor
$200 x______
= $______
Dinner Sponsor
$400 x______
= $______
Total Amount
$_____________
Payment Method
Hotel Reservations
q Check enclosed—payable to ISPE Midwest Chapter
q Bill my Credit Card—Circle Type: VISA M/C AMEX
The Hilton Garden Inn, 19677 E Jackson
Drive, Independence, MO 64057 is charging
$97 per night. Call 816-350-3000 NLT May 6,
and tell them you are with ISPE Golf.
Name____________________________________________
Card #___________________________________________
Expiration Date____________________________________
Firms that wish to donate golf balls,
hats, towels etc. as prizes should
contact Chris Clarke,
Chapter Manager.
Signature_________________________________________
ISPE Membership #________________________________
Name____________________________________________
Mail or Fax Your Registration
with Payment by 24 MAY 2013 to:
Company_________________________________________
Chris Clarke, Midwest Chapter Manager
8601 NW Overland Dr. • Kansas City, MO 64154
City/State/Zip______________________________________
Address__________________________________________
Phone___________________________________________
FAX: (816) 746-1989 Phone: (816) 741-9484
E-mail: ispemw@aol.com
Fax______________________________________________
E-mail___________________________________________
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