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
September 2013 • Number 3
&
Annual Springfield, MO Golf Outing and Educational Event
September 23 & 24
Midwest Chapter Dinner Event, Lincoln, Nebraska
October 3 2013
Springfield, Missouri Golf Outing
and Educational Event
Mark your calendar for the always popular Fall trip to Southwestern Missouri for an
afternoon of golfing followed the next morning by a panel discussion on the stainless steel
industry. Custom Powder System’s CEO Mac
McIntosh is sponsoring the event again with
ISPE Midwest Chapter.
On Monday, September 23, we meet again at
Highland Springs Country Club for the Golf
Outing. We will serve a box lunch at 11 AM
courtesy of Custom Powder Systems. The shotgun start is scheduled for 12:30 PM. Afterwards,
we will have a social hour and dinner with the
awards ceremony at the end.
On Tuesday morning, we will have a panel discussion on the stainless steel industry. Panel
discussion moderators include Mac McIntosh of
CPS, Dave Koncak of Zoetis and Jose Santos of
Merck.
The panelists will include people from
Holloway, ABEC/STI, SFI, Mueller and Custom
Powder Systems.
Topics likely to be discussed include:
New products coming to market
Disposable/Single-use system integration
Industry trends
Lead times rule of thumb
FAT: Lessons learned
The registration form are posted on the Midwest
Chapter Website at https://www.ispe.org/
midwest-chapter. Please send in your form with
payment to Chris Clarke, Chapter Manager by
September 11.
Lincoln, Nebraska Dinner Event
The ISPE Midwest Chapter travels north
to Lincoln Nebraska for a dinner event on
October 3. The event will be held at Lazlos
Brewery and Grill. The event includes a cocktail hour and a presentation on Operations
Improvement followed by a Prime Rib and
Chicken Gouda Blue dinner buffet.
Operations Improvement in the biotech/ pharmaceutical/nutraceutical arena is becoming
more prevalent as clients look to improve operational and process efficiencies, while reducing
cost and wasteful activities. The presentation
will focus on case studies to describe the strategies, tools and techniques that can be employed
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!
As this year continues to race by, I now look forward to and welcome the fall
weather and all the great fall sports that are starting. We have some exciting
events planned yet this year, and l hope you can make it to one or more of
them. It has been great this year to continue to see the support that everyone
gives to this Chapter, including the vendors, the manufacturers, and all of the
board members. As we continue to make plans for next year, I welcome any
feedback on the events we have held so far this year and suggestions for next
year’s events. Next year’s Tech/Ed day is planned to be back in Nebraska,
and we are discussing those initial plans now. A number of dinner events will
be held again in various locations as in the past, also. Please send any comments or suggestions you have to the Chapter Manager at ispemw@aol.com.
The events we have planned for the remainder of 2013 include:
• Springfield, MO
Golf and Dinner Event on September 23
Training Event on September 24
• Dinner Event in Lincoln, NE on October 3
Additional information on these events can be found in the Vice President's
Letter and in emails that you should receive as a member.
I want to again say “Thank You” to all the board members this year for their
hard work and support, and I also want to extend that thanks to all the members for their support of our Chapter. Without the support of all members and
the hard work put in by the board our Chapter would not exist.
Best Regards, Brian Beck, President
Jim Kolbet
ProPharma Group
913-661-1662 x105
Bryan Neisen
Upsher-Smith Laboratories
763-315-2667
Greg Spanel
ProPharma Group
913-661-1662 x109
www.HEMCOcorp.com
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Midwest Chapter
Programs
Eric Danielson
UPCOMING EVENTS
to identify operational improvement opportunities which can improve your productivity and
overall efficiency.
Continued from front page
has also co-authored a book chapter featured in
the Lecture Notes on Computer Science series.
He is also a co-author of the ISPE Operations
Management Guidance document.
Case studies discussed will illustrate tools and
techniques used to achieve the following results:
Kristina Pumphrey has 14 years of experience
as a process engineer in the design, commissioning, and qualification of chemical and
biopharmaceutical projects. In addition to
Bachelors in Chemical Engineering and Masters
in Management & Technology, she also is a certified Lean Six Sigma Black Belt and has spent the
last 3 years focusing on Operation Improvement
projects within the pharmaceutical industry.
• Increase in annual revenue of $7.9 Million of
an existing API manufacturing facility.
• Master planning to meet forecasted demand,
expected to double, with minimal capital
expenditures and a reduction in staffing
expenditures.
A cost avoidance of $7.4 Million.
• Reducing Production Scheduling Activities
from 3+ hours to less than 1 minute.
• 35% reduction in Cleaning Cycle Times
• Headcount reduction of more than 40%
Carrie Ballard has 8 years of experience with
CRB as a process engineer with Bachelors in
Biological Engineering. She has experience in
project engineering, coordination, and management in biotech focused facilities design. She
is the Midwest liaison to the CRB Operations
Improvement and is the point of contact for OI
opportunities in the Midwest region.
The speakers for the event are Niranjan
Kulkarni, PhD, Kristina Pumphrey, PE, and
Carrie Ballard from CRB. Niranjan Kulkarni is
an Industrial and Systems Engineering graduate and is a certified Lean Six Sigma Black Belt
and. He has worked with pharmaceutical, food,
chemical, semiconductor / electronics assembly
and packaging, manufacturing and financial
industries. He has numerous publications and
The registration form is at the end of the newsletter. Please send the form with payment to
Chris Clarke, Chapter Manager.
dhaney@meco.com
www.meco.com
www.gbabuilders.com
3
rmoore@gbabuilders.com
SEPTEISMBER
ISPE MEMBER
APPRECIATION
MONTH
www.reesscientific.com
This month, we’re celebrating
your contributions to your
companies, your industry,
to patients around the globe
and of course, to ISPE.
Thank you for being
an ISPE Member, and for:
Sharing best practices and stimulating
information-sharing among companies
and regulators to produce safe, reliable
medicines that benefit patients worldwide
Organizing and participating in strong
local Affiliate and Chapter networks
Share your Member experience with ISPE
and be entered to win an iPad Mini!
Visit www.ISPE.org/MemberAppreciationMonth for details.
Volunteering your time as the world’s
leading subject matter experts
Your commitment to choosing ISPE as
the Society of choice for your personal
and professional development
ISPE has organized a month’s worth
of special rewards and activities:
8 – 14 September: Choose any ISPE webinar, free!
15 – 21 September: Receive brand-new content developed
by select Communities of Practice.
22 – 30 September: Gain easy access to Member benefits in
the brand-new Members-only resource
section of the ISPE website.
Watch your email for more details, or visit
www.fike.com
www.ISPE.org/MemberAppreciationMonth
ISP-263_member_ad_FNL_revised.indd 1
8/30/13 1:24 PM
www.ddkscientific.com
GBATeam.com
www.geinstruments.com/cv
www.cgmpvalidation.com
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ispe international Events
3-6 November 2013
ISPE Annual Meeting
Washington, DC
MIDWEST CHAPTER EVENTS
September 23 & 24
Golf Outing & Training Event
Springfield, MO
OCTOBER 3
Dinner Event
Lincoln, NE
www.treanorarchitects.com
www.propharmagroup.com
custom-powder.com
integratedcontainmentsystems.com
www.ge-mcs.com/en/validation-and-environmental-monitoring.html
steve.scholtz@ge.com
jwynn@paulmueller.com
5
scenes from THE MN GOLF OUTING
Golfers
Dinner
Social Hour
www.burnsmcd.com/pharma
masy@masy.com www.masy.com
jason.robertson@crbusa.com
www.crbusa.com
sales@qspec.com
www.QSPEC.com
6
sales@dciinc.com
www.dciinc.com
David.Shenberger@CAgents.com
astropak.com
sixlog.com
www.commissioningagents.com
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ISPE’s Midwest
Chapter
LINCOLN, NE
dinner event
Registration Fees
PriceQuantity Total
Members
October 3, 2013
Lazlo’s Haymarket
210 N 7th Street, Lincoln, NE 68508
$70
x______ = $______
Non-Members
$90
x______ = $______
Join ISPE*
$339
x______ = $______
Students
$10
x______
= $______
Social Hour Sponsor $200
x______
= $______
Dinner Sponsor
$300
x______
= $______
VendorTable
$500
x______
= $______
(Includes two people with table)
*Attend the event and join ISPE
Total Amount
Topic:
$_____________
Payment Method
Operations Improvement
in the Biotech/Pharmaceutical Arena
Presented by Niranjan Kulkarni, PhD,
Kristina Pumphrey, PE
and Carrie Ballard from CRB
❒ Check enclosed—payable to ISPE Midwest Chapter
❒ Bill my Credit Card—Circle Type: VISA M/C AMEX
Name____________________________________________
Card #___________________________________________
Expiration Date____________________________________
SCHEDULE
5 to 6PM
Social Hour
Signature_________________________________________
6 to 7PM
Presentation
ISPE Membership #________________________________
7PM Dinner
Name____________________________________________
Menu
Company_________________________________________
Address__________________________________________
Dinner is Prime Rib Carving Station and
Chicken Gouda Blue, Roasted Potatoes,
Green Beans with Crispy Shallots, House
Salad and Dessert. Each person receives
two drink tickets.
City/State/Zip______________________________________
Phone___________________________________________
Fax______________________________________________
E-mail___________________________________________
Mail or Fax Your Registration with Payment by September 19, 2013 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
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