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
Shannon Goodson; President
Cytovance Biologics
405-319-8312
shannonwinters1@gmail.com
Mike Mills; Vice President
Mundy PharmaTech
(281) 530-8711
Steve Pondell; Treasurer
Integrated BioTech Solutions
281-253-7088
Amber Crosley; Secretary
CRB
816-880-9800
Joe Rettinger; Past President
Soliance
512-732-1210 ext. 112
October 2012, Number 3
ISPE South Central Chapter
DINNER EVENT
ARLINGTON, TEXAS
16 OCTOBER, 2012
Arlington Dinner/Education Event
Please join the South Central Chapter at their dinner event on at Olenjack's Grill, 770 Road To Six
Flags East, Suite 100, in Arlington, Texas 76011
(817.226.2600). The speaker for the meeting will be
Quinton GoForth, Manager of Reliability Services
for Genesis Solutions. Our presentation topic will be
Asset Management for Operational Excellence.
Bill Shwaiko; Director
Alcon Laboratories, Inc.
817-551-4537
Joe Sullivan; Director
Alcon Laboratories, Inc.
817-551-8556
Craig Laubacher; At Large Member
CSA-Soliance
(512) 732-1210 ext. 113
Order of Events
Social Hour/Networking
6:00 PM
Presentation
7:00 PM
Dinner
8:00 PM
Networking
9:00 PM
Chris Clarke; Chapter Manager
816-741-9484
ispesc@aol.com
continued on page three
A Message from the
for Operation Excellence” will be presented by
Quinton GoForth, Manager of Reliability Services
for Genesis Solutions, a consulting firm specializing in EAM system and reliability improvement. Please help me get the word out to all our
colleagues in the DFW area—especially our new
Members. Members and non-members alike are
welcome.
president
Greetings South Central Chapter Colleagues:
I can hardly believe its
election season already.
Not that election,
ISPE Board elections
of course. I’m happy
to announce that the
election returns are
in and our board
for 2013 has been
selected. Your new
President is Shannon
Goodson and new
Vice President is Mike
Mills. Your returning Treasurer and Secretary are
Steve Pondell and Amber Crosley, respectively.
Returning Board Directors include Joe Sullivan,
Bill Schwaiko and myself (as past president).
Craig Laubacher has been elected to the board as
an at-large member. Please join me in congratulating them in their new (or returning) roles. I’m
confident they will do a fantastic job.
If you can’t make it this time, please check the
website or future newsletters for upcoming dinner/education events in your area. These meetings benefit you, your career, your employer and
your local pharma/biopharma industry. In addition to our local events, the ISPE Annual Meeting
will be held in San Francisco this November. The
annual meeting is the industry’s best opportunity
to gather with other life science professionals to
share ideas, learn new techniques and network. I
hope to see you there.
My time as President of the ISPE South Central
Chapter is coming to a close, so this is my
farewell newsletter. It’s been a pleasure getting to know so many of you throughout the
Chapter while helping advance the goals of the
International Society. We’ve added many new
Members this year and I’m excited about the
industry investment in our region. I would like
to thank my colleagues on the Board these past
two years for their continued dedication and
hard work in making the South Central Chapter
a success. I will miss leading our small Chapter,
but I leave you in good hands for 2013. I look
forward to continue serving on the Board as Past
President and assisting our new officers.
Last May’s dinner education event in Austin
was a great success. Julie Thomas’ presentation on the Proper Care and Feeding of your
CMO was as entertaining as it was informative.
The location at the Oasis was a perfect setting
and the sunset was beautiful. On October 16,
we will be holding our final dinner/education
event of 2012 in Arlington, Texas at Olenjack's
Grill. Please make plans to join us for networking, dinner, cocktails, and an informative
industry presentation. “Asset Management
In closing, I would like to thank you for being
part of this organization and especially thank
those who have attended our meetings and
events over these past two years. Your support is
what makes this Chapter possible and a benefit to
all of our colleagues throughout Texas, Oklahoma
and Louisiana.
I look forward to seeing you in Arlington, San
Francisco or a Chapter meeting next year.
Best Wishes,
Joe Rettinger
John.Hannon@CAgents.com
Tony.Thompson@CAgents.com
WWW.COMMISSIONINGAGENTS.COM
2
South Central Chapter
DINNER EVENT
continued from page one
Presentation Outline
Presenter Bio
Asset Management for Operational Excellence
The focus of the presentation will be to look
at the importance of asset management in
terms of improved reliability, improved productivity, and cost reduction as outcomes for
a well-managed program. A proven method
of utilizing a DMAIC approach for developing a World Class asset management program will be the framework for conveying
the positive impact on Operational Excellence
with improved quality, increased production
capacity, and reduced compliance risk. Key
elements of success will be covered where
these elements serve as the foundation of any
robust asset management program. The importance of a collaborative approach will be a
consistent theme throughout the presentation
as this is imperative to achieving Operational
Excellence.
Quinton GoForth is the Manager of Reliability Services for Genesis Solutions, specializing
in EAM System and Reliability Improvement
projects. Prior to joining the Genesis team,
Quinton spent the majority of his career with
GAF Materials where he performed multiple
operations and maintenance roles within
the organization allowing him to gain a true
understanding of how to incorporate reliability and operational excellence at each level as
well as the importance of aligning the CMMS
and other data tracking platforms with these
efforts. He was responsible for the development and implementation of Reliability Centered Maintenance systems in multiple facilities. Since joining Genesis, he has assisted
several BioPharma companies in identifying
areas of opportunity and developing master
plans for improvement in their maintenance
and asset management operations. Quinton
completed his BS in Mechanical Engineering
from Michigan State University, is a Certified Maintenance and Reliability Professional
(CMRP), and a Six Sigma Black Belt through
Villanova University.
www.masy.com
www.reesscientific.com
www.propharmagroup.com
3
ispe international Events
11-14 November 2012
Annual Meeting, San Francisco, CA
keith.kettler@.crbusa.com
www.crbusa.com
www.meco.com
4
ISPE NEWS
FOR IMMEDIATE RELEASE
ISPE Issues Guidance for Ozone Water Sanitization Systems
(TAMPA, FLORIDA, USA, 14 August 2012) – ISPE announced today that it has issued new industry guidance on the design
and use of ozone systems for pharmaceutical water sanitization. The Guide provides important insight into ozone sanitization
systems, and is the first industry Guidance Document to take a holistic view of these issues. It discusses specific system requirements, as well as associated advantages and disadvantages of using ozone as a water sanitization method. The Guide will help
companies better understand what ozone systems are, why they can be a safer, more efficient and more cost-effective way to
sanitize pharmaceutical water, and how they can be incorporated into both new and retrofitted facilities.
“Water sanitization is a vital issue for all pharmaceutical manufacturing operations, and ozone systems are an extremely effective alternative to chemical and heat-based water sanitization methods. However, the absence of non-biased industry guidance
has prevented many companies from using this approach,” said Phillip Sumner, lead Guide author. “By demystifying some of
the issues associated with ozone systems, ISPE is showing industry and regulatory authorities how ozone may be incorporated
as a safer, more cost-effective sanitization alternative.”
The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems provides an overview of ozone sanitization systems, including regulatory considerations and other factors companies should take into account when deciding to use
ozone vs. other sanitization approaches. The Guide discusses the effectiveness of ozone in microbial control. System design
requirements for ozone generation, system operation and control and commissioning and qualification of ozone systems are
also covered.
The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems is available for purchase on the ISPE website.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its
Members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The
20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and
biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its
worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore;
and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.
For more information contact:
Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
email: dhould@ispe.org
www.ISPE.org
www.pspaec.com
astropak.com
sixlog.com
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ISPE South Central Chapter
DINNER EVENT
ARLINGTON, TEXAS
attendee Registration FORM
ISPE Membership #__________________________
Name______________________________________
Company___________________________________
Address____________________________________
16 OCTOBER, 2012
The event will be held
at the Olenjack's Grill, 770 Road To
Six Flags East, Suite 100, in Arlington,
Texas 76011 (817.226.2600)
City/State/Zip________________________________
Presentation
Phone_____________________________________
The speaker will be
Quinton GoForth,
Manager of Reliability Services
for Genesis Solutions.
Fax________________________________________
E-mail_____________________________________
Additional Attendees:
1. ________________________________________
Our presentation topic will be
Asset Management for
Operational Excellence.
2. ________________________________________
Registration Fees
Member
$ 30 x______= $______
Non-Members
$ 45 x______= $______
Student
$ 20 x______= $______
Vendor Table
$ 300 x______= $______
Schedule of Events
Dinner Sponsor $ 150 x______= $______
Total Amount
$______
Payment Method:
Pay at the Restaurant &
Register in Advance by October 9th, 2012
to Chris Clarke,
Fax: (816) 746-1989 • Phone: (816) 741-9484
ispesc@aol.com
Social Hour/Networking
6:00 PM
Presentation
7:00 PM
Dinner
8:00 PM
Networking
9:00 PM
7