www.ispe.org/southcentral
NEWSLETTER
Published by the South Central Area Chapter
Serving Louisiana, Oklahoma and Texas
Chapter Manager: Chris Clarke
Phone: 1.816.741.9484 and E-mail: ispesc@aol.com
Board of
Directors
Joe Rettinger; President
Soliance
512-732-1210 x112
jrettinger@solianceservices.com
Shannon Goodson; Vice President
Cytovance Biologics
405-626-0717
Steve Pondell; Treasurer
Integrated BioTech Solutions
281-253-7088
Amber Crosley; Secretary
CRB
816-880-9800
Jeff Willis; Past President
PageSoutherlandPage
713-871-8484
Bill Shwaiko; Director
Alcon Laboratories, Inc.
817-551-4537
Joe Sullivan; Director
Alcon Laboratories, Inc.
817-551-8556
Chris Clarke; Chapter Manager
816-741-9484
ispesc@aol.com
April 2012, Number 2
ISPE South Central Chapter
DINNER EVENT
austin, TEXAS
22 may, 2012
The South Central Chapter will hold a dinner event
at the Oasis on Lake Travis, 6550 Commanche Trail
in Austin, Texas 78732. The speaker for the dinner
meeting will be Julie Thomas, regulatory and quality
systems consultant and former Quality Manager for
Hospira. Her topic will be "The Proper Care and Feeding
of Your CMO".
The order of events follows:
Social Hour/Networking
Presentation
Dinner
Univ. of Houston Student
Chapter poster presentation
Networking
6:30 PM
7:30 PM
8:00 PM
8:30 PM
9:00 PM
Please fill out the registration form on page seven
of this newsletter and mail it with your check to the
Chapter Manager, Chris Clarke, at 8601 N Overland
Drive, Kansas City, MO 6414 no later than 8 May,
2012. If you have questions, call Chris at (816) 7419484 or ispesc@aol.com.
continued on page three
A Message from the
newsletters for future dinner/education events
in Dallas/Fort Worth and San Antonio later this
year. These meetings benefit your employer,
your career and the pharma/biopharma industry
in your area. I sincerely hope you will join us.
president
One of our best events of the year is coming up
in June—our annual golf tournament in Euless,
Texas (between Dallas and Fort Worth). This
event is always a lot of fun for everyone and
raise much needed funds for the Chapter.
See page eight for information on registration
and sponsorship opportunities.
South Central Chapter Friends:
I hope everyone is having a fantastic 2012 so
far. I recently conducted a very unscientific survey of the business climate across the Chapter,
and the data indicate that both new and mature
businesses in our industry are doing well. From
great academic institutions to vibrant cities and
local economic incentives, I believe this part of
the country has a lot to offer FDA regulated businesses.
We still need your help! Please help us get the
word out for these events and be sure your colleagues in the area are aware of them. ISPE
South Central members and non-members are
both welcome so please help us in supporting
the local pharma and biopharma industry and
making your South Central Chapter an important local resource.
Last month’s dinner education event in Houston
was a great success. The feedback from everyone in attendance was really positive and
Craig Laubacher’s presentation on Enterprise
Validation Strategies was very informative. A
special thanks to Jeff Willis and Steve Pondell
for organizing this event and especially to
PageSouthlandPage for hosting us.
Finally, please remember that volunteers are the
heart of the ISPE South Central Chapter and
without their time and commitment these events
would not be possible. I would like to personally thank my colleagues on the board for their
continued dedication and hard work in making
this chapter a success. If you are interested in
getting more involved with the chapter, we’re
always looking for volunteers to help with
membership, author a paper for the newsletter, or mentor young professionals in one of our
student chapters. Please feel free to send me an
email at jrettinger@solianceservices.com with
thoughts and ideas regarding our events, programs, communications or anything else.
On May 22nd, we will be holding our next education/dinner event of 2012 in Austin at the
Oasis on Lake Travis. Please make plans to join
us for networking, dinner, happy hour, a little
educating and an awesome sunset view. The
registration form for this event is on page seven
of this newsletter. Julie Thomas, former Quality
Manager for Hospira and now a respected
regulatory and quality systems consultant will
present “The Proper Care and Feeding of Your
CMO”, an important topic for many modern
pharmaceutical manufacturers. If you can’t
make it, please check the website or upcoming
See you in Austin.
Joe Rettinger
www.pspaec.com
www.meco.com
2
South Central Chapter
DINNER EVENT
Presenter: Julie Thomas
requirements of domestic and international
regulatory directives for their products. This
required her to establish quality and regulatory systems in preparation for taking a class
II medical device from design through FDA
clearance. She also managed the project plan
and budget and assured compliance of contract manufacturing operations. Since April
2011, Julie has served as an independent
consultant supporting regulatory and quality
initiatives for clients in the device, pharmaceutical and beverage industries.
Julie Thomas has over 24 years of experience
in the pharmaceutical and medical device
fields. After graduating with a BS degree in
chemistry and biology, she began working for
McNeil Consumer Products, a subsidiary of
Johnson & Johnson. Throughout her 20 year
career with J&J, she advanced through positions in quality, manufacturing and engineering, and ultimately served as plant manager.
She launched over 17 new products and
managed the start up of a new manufacturing technology in both the Austin and Puerto
Rico plants. During her tenure with J&J, Julie
received an MS in Manufacturing Management, became a Certified Quality Engineer
and received certification as a Six Sigma
Black Belt. These tools, in addition to Regulatory and Quality experience, contributed
to Julie being awarded the Quality Manager
position with Hospira, a large volume parenteral manufacturer. In her role as Quality and
staff manager, Julie was responsible for quality operations at the Austin manufacturing
site, including compliance, record management, validation, QA/QC laboratories and
audits. In February 2008, Julie joined LabNow as the Director of Quality. She was responsible for assuring that LabNow met the
Title: The Proper Care and Feeding
of Your CMO
Abstract
A mutual understanding of requirements
and responsibilities is the key to establishing
a successful relationship with your Contract
Manufacturing Organization (CMO). Ideally,
this process begins with planning, evaluation
and analysis and results in well-written Quality and Supply Agreements. Along the way,
the sense of commitment and level of detail
to quality can be assessed. We will explore
each of these aspects in our quest to achieve
the best outcomes for both the CMO and the
client.
keith.kettler@.crbusa.com
www.crbusa.com
astropak.com
continued from page one
sixlog.com
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17th Annual
South Central Chapter
Golf Tournament
We'd like to invite you to join us
sponsor or donating door prizes. We expect a full
field again this year so please submit your registration form (located on page eight of this newsletter)
as soon as possible—registration deadline is May 18,
2012.
for
the 17th Annual ISPE South Central Chapter Golf
Tournament to be held June 14, 2012 at The Texas
Star Golf Course in Euless, TX (www.texasstargolf.
com). Attached is a registration form on page eight
for your convenience.
Thanks for your support…we look forward to a
great day of golfing again this year.
Team, Banquet, and Hole-In-One Sponsorship opportunities are available, and we are also collecting
door prizes to be given away to participants during
the Awards Banquet in the event you are unable
to attend in person. Please contact Bill Shwaiko or
myself for your interest in participating as a team,
Tournament Chairman
Joe Sullivan
Sr. Director, Global Engineering
Alcon Laboratories
(817) 551-8556
ispe international Events
1-3 May 2012
INTERPHEX New York, NY
John.Hannon@CAgents.com
Tony.Thompson@CAgents.com
WWW.COMMISSIONINGAGENTS.COM
4-5 June
Redefining the "C" in CGMP
Baltimore, MD
4-7 June
Baltimore Training
Baltimore, MD
6-7 June
Pharmaceutical Supply Networks
Baltimore, MD
11-14 November 2012
Annual Meeting, San Francisco, CA
www.propharmagroup.com
4
Houston Event Summary
Houston Educational Event a Success!
Amber Crosley and Craig Laubacher at the Houston dinner/education event
The South Central Chapter is off to a great start in 2012 after the success of our first educational event of the
year on April 10th at PageSoutherlandPage headquarters in downtown Houston. The group of industry
professionals, vendors, consultants and students learned how to be leaner, meaner and greener with an
interesting presentation on risk-based validation strategies from industry expert Craig Laubacher of CSA
Soliance. Both before and after the meeting there was a great deal of information sharing between chapter
members and the local University of Houston-Student Chapter showed up in full force to network with
industry professionals.
SAVE THE DATE
THROUGH INNOVATION
AND TRANSFORMATION
2012 ISPE
ANNUAL
MEETING
GLOBAL
GMP
SOLUTIONS
11 – 14 NOVEMBER
SAN FRANCISCO, CALIFORNIA USA
MARRIOTT MARQUIS SAN FRANCISCO
Experience a New Format that is
Power Packed and Topic-Specific!
W W W .I S P E .O R G /201 2AN N UALM E E TIN G
www.reesscientific.com
5
Connecting a World of
Pharmaceutical Knowledge
www.masy.com
ISPE 2012 Training Series
Classroom Training
Aquire and Develop New Skills for Your Career
FACILITIES AND OPERATIONS
• Baltimore, Maryland USA • 4 – 7 June 2012
Turning QbD Into a Reality (New Course and Guide), Process
Validation, Sterile Manufacturing (New Course and Guide) and
GAMP® 5 Process Control
• Brussels, Belgium • 19 – 20 September
Facility Project Management (New Course), GAMP® 5, Turning
QbD Into a Reality (New Course and Guide), and Quality Risk
Management (New Course)
• Chicago, Illinois USA • 24 – 27 September
Water (New Course), Sterile Manufacturing (New Course),
Facility Project Management (New Course), Clinical Trial Materials
(New Course), GAMP® 5 and HVAC
San Francisco, California USA • 11 – 14 November 2012
Turning QbD Into a Reality (New Course and Guide),
Quality Risk Management (New Course) and GAMP® 5
www.ISPE.org/Training
Sponsorship and Table Top Exhibit Opportunities Available
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Connecting a World of
Pharmaceutical Knowledge
ISPE South Central Chapter
DINNER EVENT
AUSTIN, TEXAS
22 MAY, 2012
attendee Registration FORM
ISPE Membership #__________________________
Name______________________________________
Company___________________________________
Address____________________________________
City/State/Zip________________________________
The event will be held
at the Oasis on Lake Travis,
6550 Commanche Trail,
Austin, TX 78732
Presentation Topic:
Phone_____________________________________
Fax________________________________________
The Proper Care and Feeding
of Your CMO
E-mail_____________________________________
Additional Attendees:
1. ________________________________________
2. ________________________________________
Registration Fees
Speaker: Julie Thomas, Consultant
and former Hospira Quality Manager and
McNeil Plant Manager
Member/Guest $ 50 x______= $______
Schedule of Events
Non-Members $ 65 x______= $______
Student
$ 20 x______= $______
Vendor Table
$ 500x______= $______
Total Amount
$______
Payment Method:
Check—payable to ISPE
South Central Chapter to:
Chris Clarke, 8601 N Overland Drive,
Kansas City MO 64154
no later than May 8th, 2012
Fax: (816) 746-1989 • Phone: (816) 741-9484
ispesc@aol.com
Social Hour/Networking
6:30 PM
Presentation
7:30 PM
Dinner
8:00 PM
Univ. of Houston Student
Chapter poster presentation
8:30 PM
Networking
9:00 PM
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17TH ANNUAL GOLF TOURNAMENT
&
AWARDS BANQUET
THURSDAY, JUNE 14, 2012
THE TEXAS STAR GOLF COURSE – EULESS, TX
TEAM SCRAMBLE
Sponsor Your Own Team or We Will Set You Up
First Place Awarded in Two Flights
HOLE-IN-ONE CONTESTS
$$$ Cash, Clubs, Golf Trips, His/Hers Watches
PRIZES
Closest to the Pin, Long Drive Contests
Loads of Door Prizes and Giveaways
BUFFET DINNER AND AWARDS
Presented in the Club’s Banquet Facility
ITINERARY:
11:00 am – 12:30 pm
1:00 pm
6:00 pm – 7:30 pm
Check In & Registration and Hole-In-One Contest Sign-Up
SHOTGUN START
Buffet Dinner and Awards Ceremony
REGISTRATION FORM
Golfers:
ISPE Member No.:
Sponsor Name:
Company
Phone:
Email:
ISPE Member – Golf & Buffet Dinner
Non-Member – Golf & Buffet Dinner
Vendor Sponsored Team (Members or Non-Members)
$175.00
$225.00
$700.00
Hole-in-One Sponsor – 8 Total
Banquet Sponsor
$600.00
$300.00
MAKE YOUR RESERVATION BY FRIDAY, MAY 18, 2012* TO:
Joe Sullivan
Alcon Laboratories, Inc.
Phone: (817) 551-8556
6201 South Freeway, M/C AM-17
Fax:
(817) 551-9972
Fort Worth, TX 76134
email: joe.sullivan@alconlabs.com
Check or cash payment – no credit cards accepted. Make check payable to “ISPE South Central Chapter”
* NOTE: Submitted registration form is Sponsors’ implied agreement for payment to participate in the event - no exceptions
Visit Texas Star Golf Course website at www.texasstargolf.com for directions.
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