GSK TUMS PLANT TOUR IN ST. LOUIS
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
ISPEMIDWEST
ISPE MIDWESTCHAPTER
CHAPTER
www.ispe.org/midwest
www.ispe.org/midwest
Fall 2003
December • Number
2003 3 4
• Number
GSK TUMS PLANT TOUR IN ST. LOUIS
January 29th, 2004
GSK St. Louis has agreed to host the Midwest to get the rate of $89 per night. The hotel provides
Chapter Winter Tour Event on January 29, 2004 at complimentary ground transportation from the airport.
their TUMS Manufacturing Facility. TUMS is manu- Go to exit 13 near the baggage claim area and you will
factured at GSK's Downtown St. Louis Facility locat- see vans marked Renaissance Airport Hotel and
ed at 300 S. Broadway in St. Louis; , MO 63102, a Airport Marriott Hotel.
high rise facility that uses a continuous batch gravity
Please fill out the registration form located on our
fed process to produce TUMS for distribution
Chapter Web Site in the Events Section and fax with
throughout the world. This facility includes manu-
payment to Chris Clarke, our Chapter Manager, at
facturing, packaging and warehousing operations for
(816) 746-1989 NLT January 21st.
the manufacture of approximately 1 million bottles of
TUMS per day. As part of the tour, we will have an
opportunity to view high speed equipment, includ-
ing powder handling, tableting, and packaging lines.
For the event, we will gather at Renaissance Grand
ISPE Chapter
Airport hotel. Registration is in the hotel lobby from
noon until 12:45 PM. The group will board buses at
of the Year Award
1:00 PM to go to the TUMS plant. After a short pres-
entation, the 2-hour tour will begin. We will return
to the hotel for a Networking Hour and Dinner
before closing the program at 6:30 PM. We hope to
see you there.
TUMS is GSK's largest gastrointestinal brand. For 70
years TUMS has been a trusted remedy for safely
and effectively treating heartburn and acid indiges-
tion. It is also a pure and natural source of calcium
and the Number 1 doctor-recommended antacid and
calcium supplement. TUMS was invented in 1928 by
Jim Howe of St. Louis, Missouri to combat his wife's
indigestion. In 1930 TUMS was introduced commer-
cially and it remained a category leader until the
early 1960s. It grew again in 1984/85 when calcium
became a national health issue in the US, eventually
regaining market leadership in 1986. It is now also
recommended as a calcium supplement for women Past Midwest Chapter President Linda
who suffer from pre-menstrual syndrome (PMS) and McBride, Bayer Corp., received the ISPE
also for overall bone health. Chapter of the Year Award from Brian
Lange, Past Chairman of ISPE, at the ISPE
Those requiring hotel reservation must call the Fall Conference in New Orleans.
Renaissance Hotel NLT January 16th at (314) 429-1100
Message from the President Bart Schubert
What a privilege to step into the Presidency of a Nominating—Linda McBride
Chapter that just won three awards at ISPE’s Advisory Council—David Reed
Annual Meeting in New Orleans. Past President Our Advisory Council of industry is at an all time
Linda McBride kept the Board focused all year on high of 15. This is largely due to Dr. David Reed,
the requirements for becoming ISPE’s "Chapter of retired Vice President of Boehringer Ingelheim
the Year", and her leadership paid off on November Vetmedica and present consultant. David is taking
4! What an honor, as it is the first time the Midwest the Council to new heights, with representation
has won the award. Great job, Linda! now from major manufacturers from all five states
The new Board of Directors took office at our meet- of the Chapter’s territory.
ing October 1, just before the successful event with
Goals for 2004 - 2006
Protein Design Labs. The feedback from that tour
1. Membership: Increase the percentage of mem-
was outstanding. For complete details on the
bers from the pharma mfg-related businesses;
participant survey, see:
Improve the retention rate to exceed average of
http://www.ispe.org/midwest/events.htm all U.S. chapters; Increase the number of mem-
Committees and Chairpersons berships in NE, IA and KS representing drug-
Program Committee—Damian Gerstner related manufacturers
Membership Services—Amanda Berndt 2. Communications: Improve all communication
Student Affairs—Witold Lehmann channels to membership; disseminate information
Communications—Kirk Livingstone in a timely, user-friendly, and cost effective man
Special Projects—Greg Spanel ner; Provide alternative methods of educating
members of the MW Chapter who cannot attend
an event in person e.g., webinars.
3. Education: Increase attendance of membership at
three major events in 2004—Winter Tour, Fall
Tour and Extended Education Day; Get a higher
number of the total membership to attend any
event.
4. Advisory Council: Enable the Chapter’s
2003–2004 Officers and Board of Directors Advisory Council to become self-governing, and
Bart Schubert; President Amanda Berndt; a continual source of relevant ideas; Increase
CRB Builders The Povolny Group diversity and participation on Council.
(P) 816-914-3351 (P) 651-643-0866 5. Student Chapters: Nurture the development of
bart.schubert@crbusa.com the Chapter’s two student chapters to motivate
Witold Lehmann;
Damian Gerstner ;Vice-President CRB Consulting Engineers interest and growth; Initiate a third chapter.
Boehringer Ingelheim (P) 402-770-7578 6. Chapter Board: Improve upon the diversity of the
Vetmedica, Inc.
Kirk Livingstone; Board for 2004-2005.
(P) 816-390-0520
STERIS Corp. The committees listed above have put together
John Tashijan; Treasurer (P) 314-290-4600
T-Squared Assoc.
strategies to meet these goals. If you would like to
Michael Osborne; get more involved with the Chapter, a great start is
(P) 913-299-5090
Wyeth BioPharma
to join one of these committees. Call me with interest
Greg Spanel; Secretary (P) 314-426-2500
Wyeth Biopharma and/or questions.
Linda McBride; Past-President
(P) 314-733-3026
Bayer HealthCare LLC Grace & peace throughout the holiday and in 2004!
(P) 913-268-2877
2
Midwest Chapter Programs Damian Gerstner
Protein Design Labs Previews Programs Committee
New Production Facility The normal duties of the Programs Committee are
Protein Design Labs opened their entire clinical to establish the educational, tour, and networking
scale biopharmaceutical plant to the Midwest Chapter events in ways that meet the needs of our member-
on October 2, 2003. Over 50 people took the opportu- ship. Typically the focus is on:
nity to learn more about PDL and to network with
industry peers. • Winter Tour (this year at Wyeth BioPharma in St.
Louis, January 29, 2004)
The afternoon began with a presentation by Eric • Extended Education Day (KCI Expo Center, Kansas
Emery, Senior Director of Manufacturing. Eric high- City April 15-16, 2004)
lighted the general manufacturing flow and gave an • Golf Event (Missouri Bluffs Golf Club, St. Charles,
overview of the facility layout. The group then toured Missouri, June 17, 2004)
the PDL facilities, including utility support areas and • Fall Tour (Protein Design Labs, Brooklyn Park,
manufacturing areas containing bioreactors, media Minnesota, TBD)
preparation vessels, and chromatography systems. In addition, we hope to add new events to better serve
members outside of our traditional core cities: Kansas
Following the tour, Phil Gerlach, Director of City, St. Louis, Omaha, and Minneapolis. Our initial
Manufacturing Services, gave a preview of PDL’s full- target is likely to be Ames, Iowa, with emphasis
scale production facility, currently under construction towards our animal health membership.
in nearby Brooklyn Park, Minnesota. Facility mechan-
ical construction is scheduled to be complete in 2004. I am very grateful for the support of my committee
PDL has graciously invited the Midwest Chapter to members: Sherry Hanafin (Quintiles Consulting, Inc.),
visit the Brooklyn Park facility in Fall 2004 while the Lenny Zacks (ProPharma Group), Kris Chatrathi (CRB
facility continues its startup. Consulting Engineers, Inc.) and Joe Schadt (Northwest
Mechanical).
Eric Emery of Protein Design Labs President Bart Schuber introducing the Protein Design Lab speakers
3
Advisory Council Update David Reed
We had our Advisory Council meeting at the historic munication and help strike the delicate balance among
Nicollet Island Inn in Minneapolis on October 1 prior the stakeholders. A first vital step to the success of any
to the Midwest Chapter meeting. Our meeting goal project from building a new plant to transferring a
was to recommend new topics for Education Day and, new product is for the engineer to identify the stake-
as is the role of the Advisory Council, to give feedback holders and obtain their commitment to the project.
to ISPE from the perspective of senior management Only through good communication will this happen
of pharmaceutical companies. for commitment only comes through involvement.
This is especially true regarding involvement of senior
Two interesting topics dominated our discussions: management for they hold the key to the resources.
Project Transfer from Engineering to the End User and Failure of the engineer to obtain that commitment will
The Role of the Maintenance Organization in the result in delay, disappointment and dyspepsia. ISPE
Pharmaceutical Company. certainly has helped us with the "hard skills" of project
management, engineering knowledge, user require-
Project Transfer: It’s All About ments and guides. In addition, council members
Communication would like to see ISPE find ways help our engineers
The Advisory Council finds the Commissioning and and project managers in the "soft skills" of communi-
Qualification Baseline® Guide from ISPE to be a most cation in project management. Those skills are vital for
useful document and helps reduce the problems. In industry to improve project transfer and give us the
particular, well-defined User Requirement competitive edge.
Specifications are key and the Advisory Council
would like to see ISPE develop a standard set of ques- Role of the Maintenance Organization:
tions to be asked when developing the User What Are the Best Practices?
Requirement Document. This is the start of a quality
The view of the Advisory Council is that the
turnover package and best practice requires that all
Maintenance Organization is the first to receive budget
stakeholders be involved. The Advisory Council
cuts when the perennial budget crunches hit. It is also
members too often have seen conflicts in project
the first to be blamed when something breaks and they
transfer and in most cases the conflicts could have
could not respond or did not prevent the failure. We
been avoided through better communication and a
had much discussion on the pros and cons of outsourc-
commitment to shared responsibility. To avoid these
ing maintenance, the difficulties in setting budgets (e.g.
conflicts, the engineers must be able to facilitate com-
should we allocate maintenance dollars based on per-
centage of replacement value, percentage of cost of
goods or what?), and the absence of any benchmark
statistics. The only benchmark statistics we have found
has come from the Pharmaceutical Manufacturing
Operations Network (PMON) but it applies mostly to
laboratory operations rather than manufacturing. The
Advisory Council would like to see the ISPE, as an
independent organization, obtain such benchmark
information for our use.
www.gmplabeling.com
4
Student Affairs Witold Lehmann
Student Chapters of ISPE are established to introduce St. Louis College of Pharmacy
students to ISPE and generate interest in careers in The Student Chapter of ISPE at StLCOP is currently 20
pharmaceutical manufacturing and related fields, members strong. The President, Amanda Shaver, Vice-
which they may not have considered before. President, Julie Peradotto, Secretary, Kristin McGehee,
and Treasurer, Angela Maguire are actively trying to
Student members of ISPE are very important. They
increase membership. The chapter has monthly meet-
are the future of the industry. We currently have two
ings featuring speakers who are involved in the phar-
active Student Chapters: St. Louis College of
maceutical industry. Our chapter’s goal on campus is
Pharmacy and University of Missouri Kansas City. An
to raise awareness about the alternative opportunities
effort is under way to start the third chapter in Iowa.
available for pharmacists. The President and Vice-
We hope to have it up and running by the spring of
President were able to attend the Student Development
2004.
Committee meeting held in Washington, D.C. this
As Chairperson of the Student Affairs committee, I summer. There they learned the importance of getting
want to bring the benefits of ISPE to the attention of students involved in industry. As a result, the chap-
students throughout the Midwest. The Student ter’s plans for the spring semester include touring the
Chapters have recently established the following goals Industrial Facilities in the St. Louis area.
for the upcoming year :
University of Missouri Kansas City
• Locate specific projects at manufacturers that stu- Brian Fricke, faculty advisor, accompanied two
dents could tackle via summer internship and/or graduate students, Deep Bandyopadhyay and Arun
team semester project. Ranjan, to the 2003 Annual ISPE Meeting in New
• Schedule industry speakers for monthly meetings. Orleans, LA. The students presented their poster,
• Schedule plant tours "Numerical Model of Genetically Modified Corn
• Increase membership by 20% Pollen Transport," at the student poster competition.
• Increase poster competition participants from two to John Tashijan, from T-Squared Associates, presented
four from each chapter "A Hands on Discussion of Instrumentation and
• Participate in one community service per school year. Controls for Process Systems," at the 20 November
• Attend quarterly ISPE Midwest Chapter meetings. 2003 ISPE student meeting.
• Student Chapters President , VP and Faculty
Advisors to attend annual conference in The 14 November 2003 tour of the Boehringer
Washington D.C. in June Ingelheim Vetmedica, Inc. facility was postponed until
the Spring semester.
If you would like to assist in helping with these goals ,
establishing and supporting Student Chapters in your
area, speaking at a Student Chapter meeting, hosting
facility tours for students, or provide employment and
learning opportunities through a student internship,
please contact Witold Lehmann, Student Affairs
Chairperson, at:
402-770-7578, Witold.lehmann@crbusa.com
www.masy.com
5
Midwest Chapter Membership Amanda Berndt
Membership Committee seminar attendance and networking. Our challenge is
to create an excitement for attendance and a sense of
to Kick Off New Action Plan inclusion in this highly beneficial organization.
Aligning with the Midwest Chapter goal of aggressive
chapter growth, the Membership Committee has stat- ISPE members interested in joining the Membership
ed its focus on membership recruitment and retention. Committee will have an opportunity to "chart the new
We will be working closely with the Programs Committee course", participating in development of creative plans
to maximize attendance at Chapter events, especially to boost membership. Monthly teleconferences and
with new members. meetings during chapter events should enhance
activities and give members a chance to form new
Unlike many other professional organizations, friendships on the committee.
ISPE/Midwest Chapter members are challenged by
widespread geographic distribution throughout Iowa, If you are interested in joining the Membership
Minnesota, Kansas, Missouri and Nebraska. Whereas Committee, please call 612-875-9052 or e-mail
big city ISPE chapters, like San Francisco, hold month- amanda@povolnygroup.com
ly events, our members have fewer opportunities for
www.aesclean.com
Opportunities For:
Validation Engineers, Senior Validation
Engineers, and Computer/Controls System
Validation Engineers
Send information to: Brin Wenderski 7101 Girls School Rd., Indianapolis, IN 46241
317-381-9786 Fax 317-381-9789 800-347-5444
Propharma Group Web page www.astropak.com
E-Mail bwenderski@astropak.com
116 W. 3rd Street, Kansas City, MO, 64105
6
Chapter Communications Kirk Livingstone
This year we are looking at new and innovative speaker events, and an enhanced website. I hope this
methods to provide up to date information about the year’s growth will provide you with additional
Chapter. Also, we are investigating pathways to allow learning opportunities and increased knowledge of
members to view events which they were not able to our Chapter.
attend in person. Some of the ideas are to have the
members play a more active roll in suggesting ideas Merry Christmas and Happy New Year!
and providing feedback via our website, DVD’s of
agrant@cal-chem.com
SCHEDULE OF EVENTS
January 29, 2004
GSK TUMS Plant Tour
St. Louis, MO
April 15, 2004
Extended Education and Vendor Day
KCI Expo Center
visit www.HEMCOcorp.com Kansas City, MO
June 17, 2004
Golf Outing
Missouri Bluffs GC
al.perla@crbusa.com
St. Charles, MO
Fall 2004
Protein Design Labs Tour
Minneapolis, MN
7
www.muel.com
UPCOMING
EVENTS
February 9-12
Winter Conference
Tampa, FL
www.cgmpvalidation.com
cgmpkc@aol.com • e-mail
www.T-SquaredAssoc.com
www.QSPEC.com
#4 Midwest Drive
Suite 100
Pacific, MO 63069
Tel. 636-271-6400
Fax 636-271-6401
Serving the Midwest with ASME-BPE compliant stock
of piping components tubing, fittings, diaphragm valves,
ball valves. Stainless Steel, AL6XN, special alloys, PFA
Teflon, electropolishing and passivation www.dciinc.com
The Newsletter of the Midwest Chapter of ISPE c/o Catchword Graphics, Inc., Chris Clarke • 8601 NW Overland Drive • Kansas City, Missouri 64154
(P) 816-741-9484 (F) 816-746-1989 e-mail: ispemw@aol.com
Technical articles, regulatory reviews, product updates, news on industry trends and employment listings welcome! Fax copy to: Chris Clarke 816-746-1989
Visit the ISPE web site at www.ispe.org and the midwest Chapter’s web site at www.ispe.org/midwest
8
You can also read
