Volume 15 • Number 1
Engineering Pharmaceutical Innovation
WINTER 2008
INSIDE THIS ISSUE
President’s Message ............................................................................... 2
Board List ............................................................................................. 3
Editor’s Note ........................................................................................ 4
Spotlight Section
CASA Wins! ............................................................................................ 5
Golden LEAF BTEC Tour a Success ................................................................ 7
Local BioTech Growth: Part 1 ...................................................................... 8
Annual Technology Show Information ............................................................ 9
Special Thanks to ISPE Golf Tournament Sponsors ............................................ 10
Technical Section
Application of MPIII Temperature Dataloggers in the Quality
Assurance of Tablet Coating for the Pharmaceutical Industry.. ............................. 11
Final Rule Promotes Safe Use of Dietary Supplements ....................................... 13
Chapter Events
Student Leadership Forum ........................................................................14
Student Leadership Forum Sponsorship Opportunities .......................................16
Downstream Without a Paddle ...................................................................17
ISPE CASA Student Chapter Career Fair .........................................................20
Calendar of ISPE CASA Events ....................................................................21
Welcome our New ISPE Members ................................................................ 21
Newsletter Advertising Information & Editorial Policy....................................... 22
Thank you CASA Members!
The CASA Chapter
“Toys for Tots”
effort was a great
success thanks to our
supportive Chapter
Members!
2
President’s Message
We’re #1! We’re #1!
In case you haven’t heard,
the CASA Chapter was awarded the Platinum Grand Award
for Excellence and Innovation at the Annual Meeting
in Las Vegas last November.
The CASA Chapter was recRoy Snipes — President
ognized as the best chapter
ISPE CASA Chapter
due in part to our educational programs which all
Jim McGlade
sold out last year, our record
CASA President
donations to philanthropic
causes, our Vendor technology Show which underwent
a highly successful format change, our retention rate
increase to 88%, and the many opportunities we provided
for our members to interact and learn from one another.
This award really belongs on YOUR wall! All of the
CASA volunteers and members were the reason for this
accomplishment. Congratulations!
This year’s committees are not about to rest on these
laurels. This CASA calendar year has begun with a feverish pace. The committees have deliberated and planned
their events for the year and in many cases have already
held their first event. Please find below some quick highlights of CASA past, present and future events.
Student Development Committee:
Viva Las Vegas! The CASA Chapter proudly sponsored 13 CASA students who attended this year’s Annual
Meeting setting a new record for the number of students
Students attend Annual Meeting in Las Vegas
attending the meeting. The students took full advantage
of the vast opportunities available at this event. In fact,
three students returned with employment offers upon
their graduation. The Student Development Committee
has also been busy coordinating a Career Development
Seminar in October and plant tour of GSK in Zebulon, NC
in late November. Finally, the students helped make this
year’s Toys-for-Tots drive the most successful ever. The
Student Development Committee chairperson, Jennifer
Lauria Clark, is prepping for a very busy new year as CASA
will be hosting the Southeast Student Leadership Forum
for the second year in a row on February 9. In addition,
Jennifer is leading the planning for a Student Career Fair
on February 20 and another plant tour February 1 at the
EPA. If your company is interested in participating in this
year’s Student Career Fair please contact Jennifer for
more details at jclark@yonkersindustries.com.
Technology Show Committee:
“Navigating the Bio/Pharma Matrix” is the theme
for the 2008 CASA Technology Show on March 4. Registration for exhibitors and attendees is already underway.
Please contact David Brande, (davidbrande@earthlink.net)
or visit the CASA Web site, www.ispe.org/carolina-southatlantic/ for event and registration information. The show
is skating over to the RBC Center, home of the world
champion Carolina Hurricanes, to accommodate the
show’s growth. Attendance is FREE so plan on attending
to take advantage of the technical seminars and state-ofthe-art products that will be on display.
(continued next page)
3
President’s Message
(continued from previous page)
Programs Committee:
The Programs Committee kicked off the year by
showcasing the Golden Leaf Foundation Biotechnology Training and Education Center (BTEC), the world’s
largest biotech education and training facility, at the
Centennial Campus at North Carolina State University.
The program included speakers from the design team and
NCSU BTEC facility director, Rick Lawless. Over 60 CASA
members learned how this unique facility was conceived,
developed and constructed. Log onto the CASA Web site,
www.ispe.org/carolina-southatlantic/ for information concerning future programs.
Membership Committee:
This season of giving was highlighted by the CASA
Toys-for-Tots drive on December 13 organized by the
Membership Committee. Companies and students collected a record number of gifts at the GSK facility in RTP.
Mark your calendars for the 2008 CASA Golf Tournament
to be held on May 5 at Chapel Ridge Golf Club.
The CASA Board of Directors hope to see you at the
events listed above and wish you a Happy New Year.
Jim McGlade
Chapter President
Communications Committee:
We welcome Beth Espitia as the new chairperson for
the Communications Committee. She recently began her
term by issuing the CASA Fall 2007 Newsletter. You can
read it yourself by using the following address: www.ispe.
org/galleries/casa-files/Fall_07_ISPE_Newsletter-final.pdf
JOIN US!
25-28 February 2008
Hyatt Regency Tampa
Tampa, Florida USA
ISPE
Conference on
Manufacturing
Excellence
Seminars
• Automation and Process Control: Smart Approaches
Seminars:
for Implementing State-of-the-Art Technologies
• Single-Use Manufacturing Technology:
Selection, Implementation, and Validation
• Aseptic Processing: Fourth Annual Aseptic
Manufacturing Technology Symposium
• The Impact of PAT-oriented Process Development
and Manufacturing Operations on Data Management
• GAMP® 5: New Practical Guidance
Document for Computer Systems Compliance
• Biotechnology Facility Delivery: From Concept
to License
• Lyophilization: Meeting the Challenges of a
Critical Technology
Training courses:
• Process Validation: Today’s Practices and
• Biopharmaceutical
Facilities
Tomorrow’sManufacturing
Opportunities
• Basic Principles of Commissioning and
Qualification
www.ISPE.org/manufacturingexcellence
Training Courses
• Biopharmaceutical Manufacturing
Facilities
• Basic Principles of Commissioning
and Qualification
Technical Documents
Launched at Event
GAMP®5
Plus, one hour updates on current
technical documents.
Sponsorship and Table Top Exhibit
Opportunities Available
2007-2008 Board of Directors
Officers
• Jim McGlade, President
• Jacqui Roth, Vice President
• Mark Mathis, Treasurer
• Patrick Buckner, Secretary
Directors
• Scott Bilman
• David Brande
• Jennifer Lauria Clark
• Jack Dalziel
• Mike Engel
• Beth Espitia
•
•
•
•
•
•
Tim Howard
David Knorr
Todd McCulloch
Wes Robbins
Kirk Scofield
Blair Tyson
4
Editor’s Note
This weather is unbelievable! 15 degrees one
day and 70 degrees the next.
Well, just like the weather,
the CASA newsletter remains
to be unpredictable! I know
it has been only a short time
since you received your last
edition but the CASA Chapter
Roy Snipes — President
is planning so many things, I
ISPE CASA Chapter
wanted us to go to publication so you could learn about
Beth Espitia
them!
Communications Chair
Up first we have the Student Leadership Forum at the McKimmon Center (Raleigh)
on February 9. I was able to go to this last year and I
highly encourage everyone to go! Professionals had small
break-out sessions with student groups to answer questions and the students were very engaged and interested
in what professionals had to share.
February 13 is the event titled, Downstream without
a Paddle. It will be held at the Golden LEAF BTEC facility
and will cover a wealth of information about Tangential
Flow Filtration (TFF).
Once you’ve attended the Student Leadership Forum
and met the students, why not attend the ISPE Student
Career Fair? That’s February 20 at the new NC Biotech
Center in RTP (NC). You can meet prospective new hires
and give students an additional chance to build their
meet-and-greet skill set.
March 4 we have the mighty 2008 Annual Technology
Show. Due to its amazing success (and size), the Tech
Show will be held at the RBC Center (Raleigh). I’m looking forward to another Show with great speakers.
Finally, March 12, there will be a joint meld between
ISPE and our friends at ASHRAE. This year we’ll be at the
McKimmon Center for the topic of Bio-Containment.
I also want to point out that the 2008 editions of the
newsletter contain hotlinks, allowing readers to connect
directly to company websites from their ads. A special
thanks to our hotlink subscribers CAI, MesaLabs, STI and
Veriteq.
Enjoy the articles and, as always, Members interested in providing feedback by submitting comments
or suggestions to the editor may do so at ispe_casa_
communications@yahoo.com.
Check out the updates to the calendar and don’t miss
out on any of the upcoming events!
Best regards,
Bh Espitia
ISPE Communications Chairperson
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5
Spotlight Section
CASA Wins!
By Martin E. Rock, P.E., J.D.
OMNI Professional Environmental
Just in case you haven’t heard, I
am very pleased and excited to report
that our Chapter, ISPE—Carolina-South
Atlantic (CASA) Chapter, received the
2006-07 Platinum Grand Award for Excellence and Innovation at the ISPE Annual Meeting in Las Vegas this year. Of
course, it was a great honor to accept
this award on behalf of our Chapter in
front of over 2,000 ISPE members from
around the world, and I want to personally thank and congratulate every one of
our Chapter members who helped us to
reach this impressive achievement.
Below is an excerpt from our Chapter submittal that led to our receiving
this award:
Executive Summary
We are very pleased to report that
the ISPE-CASA Chapter had an outstandFrom left: Mark Mathis (incoming Chapter Treasurer), Jane Brown (ISPE International Board
ing year with some highly impressive
Chairman), Martin E. Rock (Immediate Past President), Shelly Pressler (Vendor Committee),
David Brande (Vendor Chair), Jim McGlade (Incoming Chapter President)
achievements thanks to an inspired team
of talented, bright, and caring volunteers. We also believe the stage is set
• CASA raised more money for charity than ever before;
for continued success and growth of the Chapter in the
• All of our educational seminars were at sold-out
years to come.
capacity,
How does one measure or judge Excellence? Actually,
• CASA improved our cash surplus nearly ten-fold in less
excellence is a difficult, if not impossible, quality to meathan 3 years, and this allows us to finance our Chapsure objectively. CASA Chapter believes that constantly
ter objectives;
striving to improve upon the many services and benefits
• CASA networking events were modified to inspire new
that we offer to our membership is the enlightened path
interest and record participation;
to excellence, so the theme you will repeatedly note
• CASA students had more opportunities than ever bewhile reading this submission is improvement.
fore to interact with and learn from industry profesThis past year truly demonstrated this dynamism and
sionals,
vitality of the Chapter as each committee challenged
• CASA newsletter was revised to include more infortheir status quo and advanced their services. In addition,
mative and educational content;
there was a palpable feeling of energy, spirit, and enthu(continued next page)
siasm throughout the Chapter and in every event, with a
75% average increase in volunteer participation across all
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� Temperature � Humidity � Pressure �
All of the Chapter’s major events are summarized
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made a number of key improvements and innovations,
solution for all of your critical temperature,
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• CASA increased our member retention rate from
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6
Spotlight Section
(continued from previous page)
•
CASA’s traditionally successful CASA Technology Forum underwent radical format changes and offered
free admission resulting in a tripling of the event
attendance.
Improvement was also experienced in the rebirth
of the Georgia market as a focused effort by the Chapter fostered a team of individuals who helped organize
several events throughout the year that have reenergized
the ISPE presence in this large market.
CASA also asserted leadership among the East Coast
Chapters of ISPE by hosting the first ever East Coast Leadership Forum in Raleigh with students attending from as
far away as Montreal and Puerto Rico. In addition, CASA
introduced the concept of an East Coast Resource Directory leading to a multi-Chapter working group on this
topic.
If improvement is a measure of excellence, as we at
CASA believe and strive for, then this past year was certainly a Year of Excellence for the CASA Chapter. We also
are being evaluated and judged on our ability to achieve
Innovation, and we believe CASA has demonstrated a
passion to innovate through some of the new initiatives
mentioned above and as more fully described in our
report below.
The Executive Summary was followed by a 10-page
description of the Chapter’s activities for the program
year. And this was the first year of a new format for the
Chapter Excellence & Innovations Awards developed by
the ISPE North American and South American Affiliates
Council (NAASAC).
The Platinum Grand Award for Excellence and Innovation is awarded to just one Chapter among all of the ISPE
Chapters within the North American and South American
affiliates, or the Western Hemisphere service area. This
year, ISPE-CASA won this award and received the plaque
shown in the photo above.
CASA last won this award, which was previously
referred to as the “Chapter of the Year Award,” in 2002.
So, let’s see if we can do it again this year . . .
Congratulations again to all ISPE-CASA Chapter members! Thanks for making it a great year.
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7
Spotlight Section
Golden LEAF BTEC Tour a Success!
By Mackenzie Miller
On Thursday, December 6th, 2007, the Golden
LEAF Biomanufacturing Training and Education Center, located on the NC State Centennial Campus, hosted an ISPE
CASA event introducing this new facility to the ISPE community. Golden LEAF BTEC is the only center
of its kind in the nation, designed expressly
to provide hands-on, industry-specific education and training.
At the December 6th event, speakers Jim
McGlade and Terry Healy launched with presentations on the conception and construction of the facility, which opened its doors
to students in September 2007. Billy Morris
followed with an update on the Validation
Academy, a partnership between BioNetwork
and ISPE that offers cutting-edge training
and education for the validation workforce in
North Carolina.
Following the presentations, tours of
Golden LEAF BTEC’s state-of-the-art facilities
were offered. These tours included the small
scale media micro lab, the small scale bioreactor lab, 30L and 300L bioreactors in the
large scale fermentation lab, the large scale
recovery lab, the high purity water system
and the analytical lab. The Golden LEAF BTEC
facility is a unique and valuable resource for
the ISPE community because it offers industry-specific training at all levels from aseptic
training courses to certificate, undergraduate, and post-baccalaureate level programs
in biomanufacturing.
8
Spotlight Section
Local Biotech Growth—PART 1:
When it comes to growth, NC excels
By Beth Espitia
It’s no secret that North Carolina has a booming
Pharmaceutical/Biotech industry. According to the North
Carolina Biotechnology Center, North Carolina ranks
among the top three biotechnology regions in the United
States, with nearly 47,000 people in 390 companies. And
the growth shows no signs of slowing down. This article
is the beginning of our four-part series focusing on developing Biotech locations throughout the North Carolina
Triangle.
The first in our series spotlights an up-and-coming
pharmaceutical company called Eisai (pronounced a-zi).
Eisai Inc. is a U.S. pharmaceutical subsidiary of Tokyobased Eisai Co., Ltd. Eisai specializes in neurological,
gastroenterological and oncological products. Their most
recognized products are Aricept, used to treat Alzheimer’s disease, and Aciphex, used to treat gastroesophageal
reflux disease. Worldwide, they produce approximately
$6 billion in sales. In the United States alone, they have
$3 billion in sales, placing them at #20 in pharmaceutical
sales.
Eisai - RTP, Aerial View
At present, the only stateside production site is
located in RTP. Eisai-RTP currently is about 190,000 ft2
on 135 acres and primarily focuses on oral solid dosage
manufacturing and formulation and analytical development. Eisai employs 280 full-time employees at the RTP
site.
Currently, Eisai’s RTP site is undergoing a major
expansion to add a central utility building and a sterile
manufacturing formulation/fill-finish suite. The combined expansion will add approximately 90,000 ft2 in new
facilities. The new sterile manufacturing expansion will
add 2 liquid fill lines—1 clinical and 1 commercial. The
expansion will also provide a warehouse (both ambient and cold) and a microbiology laboratory. All of the
equipment for the fill lines will be in isolators. The first
product expected to be produced in the new facility are
an oncology product used to treat breast cancer.
2008 ANNUAL
Spotlight Section
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10
Spotlight Section
Special Thanks to the 2007
ISPE CASA Golf Tournament
Sponsors
By Evan Moniuszko
Quality Process Skids with a Schedule Guarantee
The Membership Committee is busy preparing for
the 2008 ISPE Golf Tournament and eagerly awaiting to
see who will beat the Pro at this years hole challenge! As
we look forward to one of ISPE CASA most popular events
we want to recognize our gracious sponsors from the 2007
tournament.
Much thanks goes to all of our 2007 ISPE CASA Golf
Tournament Sponsors!
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11
Technical Section
Application of MPIII Temperature Dataloggers in the Quality
Assurance of Tablet Coating for the Pharmaceutical Industry
By Jacques Dieuvil, Pfizer and Bob Bookbinder
In the world of pharmaceutical
manufacturing the importance of
quality assurance cannot be overstated. Manufacturing errors due to
insufficient control of temperature,
humidity and or pressure can mean
product failure resulting in loss of
product efficacy and leading to a possible major economic impact on the
pharmaceutical company.
Such is the case for a major pharmaceutical company where control
of the temperature during the tablet
coating process is a critical factor in
tablet manufacture. The tablet coating
process involves tablets of compressed
medication being coated to protect
them form mechanical damage during
transportation and storage, or environmental degradation (humidity, etc),
and to control the dissolving characteristics for proper medication release.
The coating process utilizes a large
rotating drum with spray arms inside
to spray the coating material onto the
rotating tablets over time. Several
spray materials are used in steps to
coat the tablets and have the material dry between sprays. A final
tablet coating is used to “seal” or
polish the tablets before the total
cycle is finished.
Monitoring the temperature
during the tablet coating process
is essential to control the quality of
the coating. There are temperature
changes during and after the spray as
the spray material dries onto the tablets. Knowing the tablet temperature
is an indicator of the effectiveness of
each step of the spray process.
In coating, or “panning”, temperature is a result of several factors
including the temperature of the pan
itself, spray coating temperature, and
the evaporative cooling effect in the
exhaust of the pan during the final
stage of the coating process. The temperature profile of each panning run
Tablet Coating Machine
Inside a Tablet Coating Machine
MPIII Tracer with Coating Fixture
MPIII Tracer Installed In Coating Fixture
is recorded and saved as part of the
quality assurance records. A deviation from this temperature profile will
indicate a problem with the coating
process.
The solution to temperature
monitoring of the panning process
would at first appear rather simple,
just place a programmed one inch,
rigid taper tip MPIII datalogger
(Tracer) into the pan, run the process, retrieve and read the Tracer.
However, two problems need to be
addressed in the use of the MPIII in
the pan. The first is to avoid having the Tracer come in contact with
the stainless steel walls, vanes, and
spray heads within the pan which
could possibly produce particulates
and contaminate the load. The second is preventing the Tracer’s tapered sensor tip from getting caught
in the pan perforations.
A protective “fixture” is required
to prevent any exposure of the Tracer yet provide air circulation around
the Tracer’s sensor tip. A fixture was
devised to solve both problems and
win approval of the process
engineers at the pharmaceutical
company. This fixture is constructed from a piece of pharmaceutical grade heavy wall
vinyl tubing cut to fit over the
Tracer. It is approx. 2½ inches in
length with ventilation holes cut
to allow for air circulation at the
sensor end. The Tracer is held in
the vinyl fixture by the placement
of nylon “multi-purpose zip ties”
at the front and back within the
fixture.
An additional concern was
that the Tracer might ride on
top of the tablet batch (approx.
300kg) in the pan. This could
cause the Tracer to not monitor
the temperature within the mass
(continued next page)
12
Technical Section
(continued from previous page)
of tablets. However, observation of the panning process
showed the “protected” Tracer riding appropriately
within the mass of tablets as they tumbled in the pan.
The tablets are removed to a “drying Room” where the
tablets are dried under an air stream of a specific temperature. The MPIII Humidity Tracers are used here to monitor
the drying process and refine the conditions to reduced an
abnormally long drying cycle time, saving time and increasing throughput of the drying cycle,
Automation • Controls
Data from the MPIII Tracer show excellent temperature profiles of the tablet coatings that provide valuable
information for process control engineers and quality
assurance personnel. The usefulness of the MPIII Tracer in
monitoring sensitive, clean room manufacturing processes
has been well demonstrated by this evaluation.
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13
Technical Section
Final Rule Promotes Safe Use of Dietary Supplements
By U.S. Food and Drug Administration
Some dietary supplements are beneficial when
taken appropriately. Calcium supplements may strengthen bones and folic acid lowers the risk of certain birth
defects. But some supplements
pose health risks. They may contain
harmful ingredients or be improperly manufactured or handled.
On June 22, 2007, the FDA
announced a final rule establishing current good manufacturing
practice requirements (CGMPs) for
dietary supplements. In addition,
by the end of the year, industry will
be required to report all serious
dietary supplement adverse events
to FDA.
Ensuring Quality
Under the final rule, manufacturers are required to
evaluate the identity, purity, quality, strength, and composition of dietary supplements.
“The dietary supplement CGMPs should increase
consumers’ confidence in the quality of the dietary
supplement products that they purchase,” says Robert E.
Brackett, PhD, Director of FDA’s Center for Food Safety
and Applied Nutrition. “These regulations provide more
accountability in the manufacturing process so that consumers can be confident that the products they purchase
contain what is on the label.”
The final rule aims to ensure that dietary supplements do NOT have:
• Wrong ingredients
• Too much or too little of a dietary ingredient
• Improper packaging
• Improper labeling
• Contamination problems due to natural toxins, bacteria, pesticides, glass, lead, or other substances
How FDA Regulates Supplements
The final rule on CGMPs is a critical component of
the Dietary Supplement Health and Education Act of 1994
(DSHEA).
Under DSHEA, dietary supplements are regulated like foods. Unlike new drugs, dietary supplements
don’t have to go through review by
FDA for safety and effectiveness or
be “approved” before they can be
marketed. But manufacturers must
provide premarket notice and evidence of safety for any supplements
they plan to sell that contain dietary
ingredients that were not marketed
as dietary supplements before DSHEA
was passed—except that the premarket notice is not
needed if the new dietary ingredient had previously been
used as in ingredient in food.
Manufacturers are responsible for substantiating the
safety of dietary ingredients and also for determining
that certain structure/function and other claims they
make about their products are substantiated by adequate
evidence to show that the claims are truthful and not
misleading.
FDA evaluates the safety of dietary supplements after
they are on the market through research and adverse
event monitoring. The agency is responsible for taking action against any unsafe dietary supplement product after
it reaches the market.
The final rule on CGMPs gives industry clear expectations for manufacturing, packaging, labeling, and holding
dietary supplements. If dietary supplements are found to
be contaminated or lacking the appropriate ingredients,
FDA will consider those products in violation of the law
and will evaluate its enforcement options.
Life Sciences
Facility Design
Jim Nichols
Business Development
919.941.9000
jnichols@obrienatkins.com
Alan Jones
919-334-7048
alan.jones@crbusa.com
www.crbusa.com www.crbbuilders.com
14
Chapter Events
Your Time is Now !
Who Should Attend:
• Students interested in the
pharmaceutical science and
manufacturing industry as a career
choice
• Students nearing graduation
• ISPE Student Chapter Officers and
general Members
• ISPE Student Chapter Industry Advisors
• ISPE Student Chapter Faculty Advisors
• Professionals looking for student interns
Students:
• Discover the latest information on hiring
trends, skills required, and other useful
tips to help you obtain a career in the
pharmaceutical science and
manufacturing industry
• Interact and network with some of the
brightest minds from top companies
• Review résumés – be sure to bring
several copies of your updated résumé
Industry Professionals:
• Exchange ideas, information, and
lessons learned from students, faculty
and industry professionals
• Interact with the next generation of the
pharmaceutical science and
manufacturing industry
• Create brand awareness for your
company
• Prospect for potential interns and
employees
Cost:
COMPLIMENTARY to Students, Faculty
Advisors and those participating in
Student Leadership Forum (includes
lunch). Please RSVP to Tracey Ryan
at tryan@ISPE.org or register online at
www.ISPE.org/studentleadershipforum.
Tentative Agenda:
• Welcome and introductions
• Empowerment skills
• Benefits of ISPE Membership
• Break for students to work on
networking exercise
• Roundtables for professionals and
students – separate exercises centered
around student activities and Student
Chapter events
• Working lunch for students to work on
networking exercise
• Discussion on interviewing guidelines
and gaining insights into what the hiring
manager is looking for in an interview
• Roundtable – student’s personal
résumé critique
• Discussions centered around future
Student Leadership Forum events
• Wrap up for network activity
• Adjournment and final words
For more information, go to www.ISPE.org/studentleadershipforum
Save the Date
Southeast Student Leadership Forum
Saturday, 9 February 2008
North Carolina State University
Raleigh, North Carolina
West Coast Student Leadership Forum
Saturday, 9 February 2008
Embassy Suites Walnut Hill
(on the BART line)
San Francisco, California
Northeast Student Leadership Forum
Saturday, 16 February 2008
Villanova University
Villanova, Pennsylvania
Puerto Rico Student Leadership Forum
Saturday, 26 April 2008
Interamerican University at Bayamon
San Juan, Puerto Rico
For more information or questions,
contact:
Tracey Ryan
Tel: +1-813-960-2105 Ext. 279
E-mail: tryan@ISPE.org
Sponsorships are still available. For
more information, contact:
Dave Hall
Tel: +1-813-739-2274
E-mail: dhall@ISPE.org
Karen Newhouse
Tel: +1-813-960-2105 Ext. 254
E-mail: knewhouse@ISPE.org
Sponsored by the ISPE International Student
Development Committee
Your Time is Now!
15
ISPE Student Leadership Forums
Register Today!
Registration Deadlines: February Forums - Friday, 1 February 2008 and April Forum - Friday, 18 April 2008
Registration Form
PLEASE TYPE OR PRINT CLEARLY.
Forum Attending:
 Southeast
 West Coast
 Check here if you are an ISPE Member
 Northeast
 Puerto Rico
ISPE Membership Number___________________________
Prefix ______ First Name__________________________________MI_____Last Name________________________________________________
Nickname for Badge _______________________________________ Affiliate/Chapter ______________________________________________
Job Title ________________________________________________________________________________________________________________
Student’s Degree _______________________________________________
Graduation Date ________________________________________________
University/Company _____________________________________________________________________________________________________
Mailing Address ________________________________________________________________________________________________________
City ________________________________ State/Province _________ Zip+4/Postcode ________________ Country ___________________________
Tel _____________________________________________ Fax _______________________________________________________________
E-mail Address _____________________________________________________________________________________________________________
 I wish to share my information with companies interested in interviewing for a permanent position or internship.
 I wish to keep my data confidential for use by ISPE and its local Affiliates and Chapters only.
 I do not consent to photography/video
 I do not wish for my information to be printed in Conference Attendee Listings.
Dress code is business casual for professionals. Students should dress in their interview attire.
Please Check Appropriate Box
 Student Member  Student Nonmember
 Student Chapter Faculty Advisor
 Student Chapter Industry Advisor
 Industry Professional
 ISPE Student Development Committee Member
Registration: 8.30 to 8.50
Workshop Sessions: 9.00 to 17.00
www.ISPE.org/studentleadershipforum
I will Attend
 Lunch (12.00 - 13.00)
Special Meal Requirement
 Vegetarian
Register on-line or Fax registration form to:
ISPE Headquarters
3109 W. Dr. Martin Luther King, Jr. Blvd.,
Suite 250, Tampa, FL 33607 USA
Tel: 1-813-960-2105 • Fax: 1-813-264-2816
www.ISPE.org • FEI #59-2009272
16
2008
Student Leadership Forum
Sponsorships
Maximize Your
Company’s Exposure!
Gain access to the next generation of
pharmaceutical manufacturing industry
leaders by partnering in conjunction with
the 2008 ISPE Student Leadership Forums.
These events are designed to promote the
exchange of information, ideas, and
lessons learned among students, industry,
and faculty; teach/review students’ networking skills; review résumés; and create
engagement among all attendees. Attendees
include students interested in the
pharmaceutical industry as a career choice;
ISPE Student Chapter Members; and
students nearing graduation.
Sponsorships are limited, so maximize your
exposure by reserving your sponsorship early!
To reserve your sponsorship at ISPE’s 2008
Student Leadership Forums, please complete
the registration form and return to ISPE. For
more details on sponsorships, contact Dave
Hall at dhall@ISPE.org or Karen Newhouse
at knewhouse@ISPE.org or by tel +1-813960-2105.
Sustaining Sponsor
(Sponsor all four forums): $5,000
• Button ad with link on Student Leadership Forum Web home page
• Company recognition via promotional e-mails for all four Forums
• Company recognition via on-site signage at all four Forums
• Complimentary attendance for two company representatives at all four Forums
• Table top exhibit space at all four Forums
• Company recognition at all four Forums by Welcome speakers
• Access to attendee list at all four Forums
• Opportunity for company promotional item give-away at all four Forums
Major Sponsor
(Sponsor three forums): $3,000
• Button ad with link on Student Leadership Forum Web home page
• Company recognition via promotional e-mails for three Forums
• Company recognition via on-site signage at three Forums
• Complimentary attendance for two company representatives at three Forums
• Shared literature table at three Forums
• Company recognition at three Forums by Welcome speakers
• Access to attendee list at three Forums
• Opportunity for company promotional item give-away at three Forums
Event Sponsor
(Sponsor two forums): $1,000
• Company name mentioned on Student Leadership Forum Web home page
• Company recognition via promotional e-mails for two Forums
• Company recognition via on-site signage at two Forums
• Company recognition at two Forums by Welcome speakers
Supporting Sponsor
(Sponsor one forum): $500
• Company name mentioned on Student Leadership Forum Web home page
• Company recognition via on-site signage at one Forum
• Company recognition at one Forum by Welcome speakers
www.ISPE.org
17
Presents
Downstream Without
A Paddle
Wednesday
February 13, 2008
3:00 pm—6:00 pm
$40 Members; $50 Guests
$10 Students —
1st 10 Free
Don’t get caught up downstream without a paddle. Join
ISPE-CASA for an afternoon of Downstream presentations
and discussion, followed by Networking with light buffet.
Keynote speakers and topics planned are:
Location
Theory and Principles of TFF
Aaron Allen (Jacobs Engineering Group)
Larry James (CRB Consulting Engineers, Inc.)
Practical Applications of TFF
Mark Trotter (Sartorius Stedim Biotech, Inc.)
Theory, Principles and Application of Centrifugation
Mike Rohr (Westfalia Separator, Inc.)
Sponsor Opportunities Available
Golden LEAF Biomanufacturing
Training & Education Center
850 Oval Drive
Raleigh, NC 27606
919-513-2000
18
Downstream Without
A Paddle
Wednesday, February 13, 2008
3:00 pm until 6:00 pm
Registration (One per individual)
ISPE Member #
Name
Company
Address
City/State/Zip
Phone/Fax #s
Email
____
Member:
$40.00 per person
____
Non-Member:
$50.00 per person
____
Student:
$10.00 per person 1st 10 FREE
Parking permits are required to park in the deck adjacent to BTEC and will be sent with your
registration confirmation. Parking violators may be towed and subject to a $40 fine.
Sponsorship Opportunity

My company would like to sponsor this event ($250.00)
PAY BY CHECK OR CREDIT CARD
Name on Credit Card

CHECK
AMEX


Credit Card #
VISA

Master Card
CC Exp Date
Billing Address _____________________________________________________________
_________________________________________________________________________
Signature ____________________________
Date ____________________________
Email, fax, or mail this form to:
Cathy Rothey c/o ISPE Carolina-South Atlantic Chapter
605 Poole Drive, Garner, NC 27529
Phone: 919-861-1123 / Fax: 919-779-5642 / Email: ispe-casa@mgmt4u.com
Please feel free to make multiple copies of this flyer to post on your company bulletin board.
19
Directions to the Golden LEAF BTEC Building
From the Raleigh Beltline (I-440):
From the Raleigh Beltline (I440), take Western Boulevard
East towards NC State and
then turn right at the fifth
traffic light onto Avent Ferry
Road. At the second light, turn
left onto Varsity Drive. Continue straight on Varsity Drive
until it reaches a dead end at
Partners Way. The back of the
BTEC building will be on your
left and you can park in the
second deck on the left. Enter
the main lobby through the
front entrance of the building,
and pass through the wood
double doors on the left to
reach the BTEC main office.
From I-40:
From I-40, take the Gorman
Street exit towards NC State.
Turn right onto Avent Ferry
Road (second light), then turn
right onto Varsity Drive (first
light). Continue straight on
Varsity Drive until it reaches a
dead end at Partners Way.
The back of the BTEC building
will be on your left and you
can park in the second deck
on the left. Enter the main
lobby through the front entrance of the building, and
pass through the wood double
doors on the left to reach the
BTEC main office.
Visit the BTEC website at http://www.engr.ncsu.edu/btec for more information.
Permits are required to park on the Centennial Campus. The permit fee is included
in your registration and will be sent with your registration confirmation.
20
����������������������������������������
�����������������
6:00 – 8:00 PM
North Carolina Biotechnology Center
Research Triangle Park, NC
The ������������������������������� of ���� will sponsor a ������������������� on
Thursday, February 20, 2008, from 6:00-8:00 PM at the Charles Hamner Conference Center at
the North Carolina Biotechnology Center. Students from �������������������������������
�����������������will attend. This Career Fair will provide you with the opportunity to meet
industry recruiters and leader. It is a great opportunity to make contacts regarding potential job
opportunities. If you are interested in attending, please complete the registration form below
and return by February 11, 2008. There is no charge to students (�������). If you have any
questions, contact Jennifer Lauria Clark at 919-604-2720, jclark@yonkersindustries.com or
Amy Lineberry at 336-686-8727, amy.lineberry@cagents.com. A list of companies attending
the career fair will be sent out in January.
�������������������������
University: circle one: Campbell Clemson NCA&T NCCU NCSU UNC-CH Other: ______
Name:
____________________________________ ISPE #:(if applicable): __________
Address:
St._____________________________ City: _____________ Zip Code: ________
Officer:
yes or no: _____
Phone:
______________________ Email: ______________________________________
If yes, what position: _________________________
What companies would you like to see at the career fair? Please list specific company names
and types (oral solid dosage, biotech, etc.)
__________________________________________________________________
__________________________________________________________________
���������������
Cathy Rothey, Management Concepts, Inc.
605 Poole Drive
Garner, NC 27529
Fax: 919-779-5642 Phone: 919-861-1123
Email: ispe-casa@mgmt4u.com
21
Chapter Events
Click here for ISPE’s Global Event Calendar For more information, contact Cathy Rothe, Chapter Manager
Carolina South Atlantic Chapter Events Calendar
MONTH
LOCATION
PROGRAM
February 9, 2008
ISPE Student Leadership Forum
McKimmon Center, NC State University
Raleigh, NC
February 13, 2008
Downstream Without A Paddle
BTEC Center, NC State University
Millennium Campus, Raleigh, NC
February 20, 2008
ISPE-CASA Student Chapter Career Fair
NC Biotechnology Center, RTP, NC
February 25–28, 2008
Conference on Manufacturing Excellence
Tampa, Florida
March 4, 2008
Technology Show
RBC Centre, Raleigh, NC
March 12, 2008
Bio-Containment
(Joint meeting with ISPE and ASHRAE)
McKimmon Center, NC State University
Raleigh, NC
NC Water Restrictions and the
Effect on the Pharma Industry
Location: TBD
May 5, 2008
Annual Golf Tournament
The Golf Club at Chapel
Ridge, Pittsboro, NC
May 22, 2008
Novartis-Pandemic Flu
Angus Barn, Raleigh, NC
April 17, 2008
We welcome our newest CASA
Members!
Nicholas J. Armstrong
James V. Baggett, Jr.
Shawn K. Blue
Benjamin Buscato
Francis X. Chambers
Joseph Ty Chapman
Joseph E. Cobb, Jr.
Michael R. Couillard
Kelly A. Fowler
Richard Cole Garner
Yolanda Hill
Ajay Jariwala
Matthew B. Lambert
Stephen Leung
Jeffery R. Leverton
Brian McGaulley, PMP
Kathryn L. Mintz
Stacy A. Mitchell
Greg L. Morris, Sr.
Alan Keith Peacher
Stephen M. Peterson
Eli M. Pollack
Joseph D. Renwick
Richard A. Reyf
Loren Rideout
Cathy Rothey
Rebekah Sickler
Richard Snoddy
Ronnie L. Thompson
Jason Vanderploeg
Michael Vasquez
Mollie K. Warren
Van Young
For corrections, or even worse, omissions, please
contact Todd McCulloch, Membership Committee, at
TMcCulloch@pci-llc.com.
Got News?
Send it to: ISPE_CASA_
COMMUNICATIONS@YAHOO.COM
Entries should be brief and be of general interest
to the readership. Entries must include a name and
telephone number for verification purposes. We reserve the right to edit and select entries.
22
ISPE CASA Chapter
E-Newsletter Ads
Newsletter Ads Work for
your Business!
Our Chapter produces four e-newsletters per year,
and we depend on the support of our advertisers.
We send out the newsletters via e-mail and via web
link to all of our Chapter Members throughout the
Southeastern U.S.
That means you get targeted access to topnotch pharma, biotech, and bio-science professionals and managers. These newsletters are also
posted on our Web site so your ad can be accessed
by interested visitors to our site.
Best of all, the cost is only $500 for your full
color, business-card-sized ad for four insertions.
That’s only $500 for targeted advertising in full
color for an entire year!
Ask About
HOT LINKS!!
Would you like to have targeted customers simply
click on your ad and get right to your Web site?
A hot-link can be added to your ad, connecting
readers directly to your company Web site for an additional $500.00 for a whole year.
If you are interested in advertising with the ISPE
CASA e-newsletter, please complete the order form
and return to:
Beth Espitia
AMEC
4513 Creedmoor Road
Suite 400
Raleigh, NC 27612
ispe_casa_communications@yahoo.com
You will be notified via e-mail or telephone when
your advertisement has been accepted by the ISPE
CASA Communications Committee and asked to
submit your advertisement digitally.
Full-color business card-sized ads (3.5” x 2”)
may contain your logo or other artwork. Artwork should be sent directly to ispe_casa_
communications@yahoo.com.
We ask that your text be no smaller than 12 pt so
that the text is easily readable in the electronic
format. PDF, JPEG or TIF formats are easiest for us
to work with. Space is limited, sign up today!
ISPE Carolina-South Atlantic
Chapter Newsletter
605 Poole Drive
Garner, NC 27529
Tel: 1-919/861-1123 • Fax: 1-919/779-5642
ispe_casa_communications@yahoo.com
EDITORIAL POLICY
Articles should be written for technical professionals in the pharmaceutical, biotechnology,
and medical device industries. The author is
responsible for the accuracy and correctness of
all statements contained in the manuscript (ISPE
Carolina-South Atlantic Chapter assumes no liability.) Manuscripts should be forwarded to a Member
of the Communications Committee at ispe_casa_
communications@yahoo.com for review 30 days
prior to publication. A brief three to four sentence
synopsis of the article, as well as a brief biographical statement about the author that includes educational background, title and job affiliation, job
responsibilities and major areas of accomplishment
must accompany the article.
Communications Committee Members
Beth Espitia, Chair
Mackenzie Miller
Evan Moniusko
Pavun Patel
Kevin White
David Yaffe
Got News?
Send it to: ISPE_CASA_
COMMUNICATIONS@YAHOO.COM
Entries should be brief and be of general interest
to the readership. Entries must include a name and
telephone number for verification purposes. We reserve the right to edit and select entries.
A word to the ISPE CASA Newsletter advertisers,
thank you all for your continued support, without it
we could not be able to have the wonderful support
staff to get our ISPE CASA Members the news in such
and timely and professional fashion. If you have updates to your advertisements or find any other error,
please contact us so that we can serve you better.