ISPE Matters
2012
FALL/WINTER
A
2012
ISPE Delaware Valley Chapter | tel.610.351.3874 | fax.610.351.9136 | Email rdgrafx@aol.com | www.ispe.org/delawarevalley
Inside this Issue
From the President
25th Anniversary Planning ................... 1
From the President
By: Shannah Schodle, ISPE-DVC President
ISPE Upcoming Events ......................... 1
ISPE Partnering with PA Bio ................. 2
Board of Directors................................ 2
New Website Update ............................ 3
DVC at 25 Years and Counting .............. 3
ISPE International Events..................... 3
September Program Meeting ................ 4
Advertise in ISPE Matters .................... 4
October Program Meeting..................... 5
Volunteers Wanted ............................... 5
ISPE DVC Big Winners .......................... 6
As we commemorate our 25th
Anniversary, our Board is poised
and excited to provide members
with relevant timely programs,
affordable in-depth education
opportunities and abundant
networking. Our mission statement
for the year, “Increase our value
proposition to members,” remains
at the forefront of our strategic and
tactical planning. We’re working
to offer diverse programming,
increased social media and
marketing, as well as improving
our operating procedures to drive
efficiency and ease of use.
Social Networking ................................ 7
Educational Meetings........................... 7
The ISPE Matters Delaware
Valley Chapter Newsletter is
created by the Marketing and
Communications Committee.
For information on how you can
contribute, please contact
Ellen Venezia, VP MAC, at
Ellen.venezia@fwbiok.com.
I recently attended meetings with
leadership of other chapters and
affiliates throughout the world
during the Annual Meeting.
In addition to discussing best
practices, lessons learned and
information sharing, I was able
to learn more about the direction
of ISPE internationally. Under the
leadership of Nancy Berg, the
society member are reinvigorating
their passion, refocusing their
direction and engaging more
industry leadership and regulatory
agencies. I am grateful to be part
of the society during this exciting
time and optimistic to participate
in path forward.
We are laying the framework,
but surely have more work to
do. We recently hosted a group
of end-users to find out ways in
which the society can support
their corporate initiatives, training
needs and generally get them
more entrenched in the chapter.
Companies represented included
Merck, J&J, GSK, Teva, Morphotek
and Actavis. Our lively discussion
provided invaluable feedback on
areas we can improve and evolve
to better meet our member needs.
We look to you, our membership,
to provide us with the feedback
and input necessary to better
meet your needs. I’d encourage
those of you that don’t typically
attend our events to attend. Those
of you interested to help with a
committee or if you have an idea
or thought, don’t hesitate to reach
out. For those of you that are
already involved, I thank you for
your continued support. To all of
our membership, I wish you all
the best in the coming new year
and another successful 25 years
to come.
Sincerely,
Shannah Schodle
ISPE- DVC Chapter President
If you have any comments,
questions, or concerns about
ISPE-DVC, or would like to
make a suggestion about future
programs events or topics,
please feel free to e-mail me at
Shannah.Schodle@crbusa.com
Date!
Save the
ight
Vendor N
at
13, 2013
February
k
Bank Par
Citizen’s
Connecting a World of
Pharmaceutical Knowledge
Delaware Valley Chapter Upcoming Events
January 15
Program Meeting - Injectible Drug Delivery Systems Presentation (PM)
Connecting a World of
Pharmaceutical Knowledge
ISPE Delaware Valley Chapter
tel.610.351.3874
fax.610.351.9136
Email rdgrafx@aol.com
www.ispe.org/delawarevalley
January 18
ISPE-DVC Ski Trip
February 13
ISPE Vendor Night
ISPE Matters 2012
ISPE-DVC
Board of
Directors
President
Shannah Schodle
CRB
Executive VP
Matthew McMenamin
GlaxoSmithKline
Treasurer
Renaldo Trancoso
Merck
Secretary
Alan Levy
Javan Engineering
Delaware Valley Chapter
ISPE-DVC Partners with PA Bio:
Increasing Biopharma Community Exposure
By Shannah Shodle, ISPE-DVC President
In following with our mission of
increasing the value proposition
to our members, ISPE DVC
established a strategic partnership
with PA BIO. This partnership
will expose DVC members to a
diverse biopharm community,
their perspectives, and their
contributions to the local life
sciences environment. The
mission of Pennsylvania Bio is
to ensure Pennsylvania is the
global leader in the biosciences
by creating a cohesive community
that unites our biotechnology,
medical device, diagnostic,
pharmaceutical, research, and
financial strengths.
There are abundant synergies
between these communities, as
ISPE-DVC and PA Bio Members
all work to provide compliant
innovative solutions to deliver
cost-effective quality products
that save patient lives. To achieve
this goal, the associations must
remain nimble in the evolving
life science environment, staying
abreast of the latest technologies,
industry trends, and scientific
advancements.
VP, Programs
Matthew Snyder
GlaxoSmithKline
This partnership will provide
expanded networking and
educational opportunities to
members through cross promotion
of events and member pricing. All
ISPE-DVC Members will receive
a 10% discounted rate or receive
Member pricing for attending PA
Bio Events.
Your challenges today
are not what they were yesterday
and will not be the same tomorrow.
VP, Education
Emilie Pelletier
Laporte Consultants
VP, Marketing
Ellen Venezia
Foster Wheeler Biokinetics
This partnership will allow for idea
exchange and lively discussion of
such pertinent topics, expanding
our knowledge and enhancing our
practice.
We Listen. We Deliver... more flexibility.
If you’re ready to be heard, CRB is ready to listen.
CONSULTING | DESIGN | CONSTRUCTION | COMMISSIONING | QUALIFICATION
Shannah Schodle
610.278.7644
www.crbusa.com
VP, Young Professionals
Alex Myers
IPS
VP, Student Advisory
Jamie Angelastro
FlexPro Group
Past President
Robert Matje, CPIP
Endo Pharmaceuticals
Director
Mike Lanasa
Integra Life Sciences
Director
Randy Leinhauser
Merck
Director
Dennis Gross
Thomas Jefferson University
Architects
Engineers
Construction Managers
www.geieng.com • 610-592-0280
Central Utilities | cGMP Compliance | Clean Rooms | Energy & Sustainability | EPCM | Labs | Mission Critical | Strategic Program Development
ISPE Matters 2012
Delaware Valley Chapter
International
Events
Our New Website is LIVE!
Critical Utilities Intensive:
Cost-Optimization Alternatives
for Critical Utilities
Just in time for the first
(September) program meeting,
we went live with ISPE-DVC’s
new modernized website! Matt
Snyder, current VP of Programs
and last year’s VP of Marketing
and Communication worked hard
all last year with his team and
our website integrator, Javelin
Design, to create a website that
aesthetically matches the ISPE
National website and allows for
secure registration to our ISPEDVC events.
25 - 26 February
Tampa, Florida USA
Tampa Classroom Training
25 - 26 February
Tampa, Florida USA
GAMP® 5 and Oral Solid Dosage
Aseptic Conference: Barrier
Isolation, Sterilization and
Disposables
4 - 5 March
Baltimore, Maryland USA
Baltimore Classroom Training
4 - 5 March
Baltimore, Maryland USA
Auditing and Clinical Trial Materials
Executive Forum: Best
Innovation and Quality
Practices from Non-Pharma
Industries
2 - 3 April
Philadelphia, Pennsylvania USA
Registration Coming Soon!
Newton Classroom Training
(Boston Area)
8 - 11 April
Newton, Massachusetts USA
Water, HVAC, Sterile Facilities,
Biopharmaceutical Facilities,
Biomanufacturing Practices and Q7A
St. Louis Classroom Training
20 - 23 May
St. Louis, Missouri USA
Water, Cleaning Validation, Commissioning
and Qualification, GAMP® 5, Quality Risk
Management, Facility Management
ISPE 2013 Annual Meeting:
Quality Throughout the
Product Lifecycle
3 - 6 November
Washington, DC USA
Submit your call for proposals abstract
before 15 December!
By Ellen Venezia, ISPE-DVC VP of Marketing and Communication
One of the biggest improvements
is the change-over to processing
registrations via PayPal. This
not only provides an extra layer
of security to our members, it
reduces the amount of processing
for Ron Dunn, our Chapter
Manager. I know Ron is happy
about that!
we thank you for your patience.
Our team has been working hard
to make the website better and
better each day. We are a long
way from completing all of our
wants and needs, but we expect
the following upgrades to be rolled
out soon: group registration, easier
access to program descriptions,
and automatic reminder emails
sent directly to registrants.
Welcome to ISPE-DVC
About ISPE-DVC
Upcoming Events
Board Members
Yes, we know that there have
been many bumps along the way
with the registration process and
Committees
Many of you have provided
feedback about the website along
the way and we have certainly
taken your comments to heart.
We are working to make your
desires for the website a reality.
As always, feedback is more than
welcome so please feel free to
submit your comments to
Ellen Venezia, VP MAC,
Ellen.venezia@fwbiok.com.
Welcome to ISPE-DVC
We are an independent organization led by the world’s top pharmaceutical manufacturing professionals. We provide an inviting
and neutral environment for experts, technologists, regulators, consultants and students to exchange ideas and practical
experience. As a vibrant community, ISPE’s Members work together to improve the industry, while helping each other make
better choices, more quickly than ever before.
ISPE partner events
Contact Us
As an ISPE Member, you have access to special privileges and benefits only Members can experience. ISPE offers you valuable
information, resources and tools to help you achieve professional competency, recognition and advancement.
The DVC at 25 Years and Counting…
By Matt Snyder, ISPE-DVC VP, Programs
With 25 years as one of the
leading chapters in the ISPE
realm, the Delaware Valley
Chapter is taking this opportunity
to celebrate our past while looking
forward to our next 25 years. We
have planned a 25th Anniversary
Celebration event that will coincide
with our annual Holiday Party on
December 13, 2012. The event
will feature a look back at some
of the memorable events that the
DVC has held over the past 25
years, who are leaders were and
the many notable achievements
and awards given by and granted
to the chapter. A photo history
has been assembled along with
an acknowledgement of all of our
esteemed past presidents.
Upcoming ISPE Events:
ISPE is the world’s largest not-for-profit association dedicated to educating
and advancing pharmaceutical manufacturing professionals and their industry.
Founded in 1980, today ISPE serves more than 22,000 members in 80
countries.
We have invited the current
President and CEO of the ISPE,
Nancy Berg, to join us at the
Crystal Tea Room in center
city Philadelphia in celebrating
this momentous occasion. She
will speak to the future of the
organization and how our chapter
can contribute to the continuing
success and growing relevance to
the pharmaceutical industry.
Much effort has gone into
assembling a comprehensive look
back at the history of our chapter
that should provide a great archive
for future chapter leaders. This
evening will conclude with many
of our past presidents, including
our first president, John Cocco,
leading a toast commemorating
our past, present and future.
ISPE Matters 2012
Delaware Valley Chapter
Advertise in
ISPE Matters
September ISPE-DVC Program Meeting:
Practical Risk-Based C&Q
ISPE Matters is the perfect
spot for advertising your
business! We reach the heart
of the pharmaceutical industry
in the Delaware Valley. The
standard ad cost is $250 and
will be printed in all issues
this year. If you are interested
in advertising in ISPE Matters,
Please contact: Ellen Venezia
Ellen.venezia@fwbiok.com
The presentation regarding RiskBased C&Q was very successful
and included an overview of the
group’s COP, presentations on
two real examples, and a panel
discussion. The two presentations
provided an overview of J&J’s
and Pfizer’s experience regarding
the use of Risk-Based C&Q
including a financial analysis that
compared this approach to the
old way of doing commissioning
and qualification. Later in
the discussion Mark Rezac
added additional flavor to the
discussion by providing an
overview of Merck’s experience
with implementing this C&Q
approach.
The two presentations will be
posted on the web site for your
review. We hope to continue this
discussion with the community,
including the tracking of cost
savings after Risk-Based C&Q
and its impact on operating and
maintenance costs, such as
change control management and
calibration.
ISPE Matters 2012
We Need You!
Volunteers
Wanted
We are always looking for
volunteers for our committees!
You can now volunteer for a
committee via the DVC website.
Please feel free to contact any
member of the Board with
ideas, thoughts or contacts
you might have to enhance the
Delaware Valley Chapter. If you
are interested, please contact
Shannah Schodle, President
Shannah.Schodle@crbusa.com
Delaware Valley Chapter
October ISPE-DVC / PA Bio Program Meeting:
Future of Biopharm Facilities: Transitioning to Single-Use
The presentation/discussion
focused on the opportunities
and challenges with moving
existing biological processes
into single use systems. It was
based on a study of an actual
tech transfer consideration. The
discussion highlighted both facility
and equipment considerations
showing how design of the
facility evolved with deployment
of single use systems. Cost,
schedule, process development,
geographical considerations and
single-use technology limitations
were highlighted. There was
special focus on single-use
bioreactor risk-assessment as a
case study. Leading this program
was industry experts, Greg Krupa,
Director of Process Engineering in
Global Engineering Services with
Merck & Co. Inc. and Tom Bryant,
Senior Director of Engineering
& Industrial Technology for US
operations of Sanofi Pasteur, Inc.
The event was a follow-up
program co-located with the
BIOTECH 2012 event presented
by PABIO and NJBIO.
ISPE Matters 2012
Delaware Valley Chapter
ISPE DVC are the BIG Winners for “Engineer
of the Year” and “Young Engineer of the Year
Competition” By Alan Levy, ISPE-DVC Secretary
ISPE-DVC would like to congratulate Charles Clerecuzio, PE, CPIP, and Alan S. Levy for being selected,
respectively, as the 2013 Delaware Valley “Engineer of the Year” and “Young Engineer of the Year” by the
Engineers’ Club of Philadelphia.
The Engineers’ Club of Philadelphia holds an annual competition between all the local engineering
professional societies to select a single “Engineer of the Year” and “Young Engineer of the Year” across the
Delaware Valley region. After attending an Engineering Society Summit in September, ISPE-DVC chose to
participate in this competition for the first time. ISPE-DVC’s selection criteria for the candidates included a
degree in engineering (mandatory), a substantial professional resume, proven commitment and involvement
in ISPE-DVC, as well as excellence in academics and civic involvement.
The “Young Engineer of the Year” criteria include a prerequisite that the engineer must be age 35 or less.
The ISPE-DVC Board of Directors nominated Charles (Chuck) Clerecuzio as our candidate for “Engineer of
the Year,” and Alan Levy as our candidate for “Young Engineer of the Year” for exemplifying these qualities.
Chuck Clerecuzio,
PE, CPIP has had a
distinguished career that
encompasses an impressive
and diverse catalogue of
professional experience in
business, academics, and
community support which
led him to be selected
as the 2012 Chemical Engineer of the Year
for Delaware Valley by the American Institute
of Chemical Engineers. In business, he has
worked in several different industries on both
the consulting and operating company sides.
Recognition of his leadership and expertise is
evident in his most recent posting as President
of Solutions4CO2, an international bioenergy
company. Academically, Chuck has an enduring
desire to engage and learn. He recently passed
his qualifying exam for the Chemical Engineering
doctoral program at Rutger’s University, which
he is pursuing part time, while teaching
bioengineering as an Adjunct Professor at Rutgers
University and Rowan University. Across his
career, Chuck has been heavily involved with
ISPE and is a Past President of the Delaware
Valley Chapter. Chuck is also a Past President
of the Philadelphia Section of AIChE, who cosponsored his nomination for “Engineer of the
Year.” Prior to his presidency, Chuck dedicated
his time within ISPE to the promotion and
development of our Student Chapters to publicize
the industry and encourage future engineers to
get involved in Pharmaceuticals.
Alan S. Levy, a Project
Manager for Javan
Engineering, started
in the Pharmaceutical
industry in 2002 after
moving to the Philly area
from Missouri, where he
attended college at the
University of MissouriRolla. Professionally, Alan held contract
engineering positions in Maintenance and
Reliability, Utilities, and Facilities Engineering at
Merck early in his career. As a project manager,
he has managed a host of design projects
ranging from small air handler replacements
and infrastructure upgrades to managing the
design of a 75,000 sq-ft lab building renovation
in tandem to the design of a site-wide steam
distribution replacement. He has also worked
on the Commissioning and Qualification team of
a $100M+ project to get well-known children’s
medicines back on the market. Within ISPE,
Alan has been on the Board of Directors of the
DVC since 2008; first as VP of Membership,
then as VP of Education, and he currently
serves as Secretary of the Executive Board.
Alan was responsible for the DVC’s revamped
educational programming by instituting the very
success monthly evening sessions that provide
3 PDHs, inexpensively, to our chapter’s PEs
while helping to train our young professionals.
Alan also judges the annual Student Poster
Competitions and the Engineers’ Club’s
“Future Cities Competition” that encourages
6th-8th graders to get involved in science and
engineering, in addition to mentoring students
at the Student Leadership Forum.
Congratulations again to our winners, as well as the Pharmaceutical industry as a
whole for enabling ISPE-DVC to sweep the awards by the quality of our engineers.
ISPE Matters 2012
Social
Networking
DVC members are invited to join
our group on LinkedIn for event
notifications, networking and
information sharing. Find us on
LinkedIn at ISPE-DVC.
Delaware Valley Chapter
ISPE-DVC Educational Meetings
OCTOBER - Packaging and Labeling System as a Part of Quality
Management System in the Pharmaceutical Industry
On October 3rd 2012, members gathered at the GSK campus in King of Prussia for an Education
Session. The presentation was given by Yefim Gudesblat, PE. Yefim has over 30 years’ experience in the
pharmaceutical industry and a strong expertise in packaging technologies.
The presentation focused on methods and regulations for the packaging security labeling in the manufacturing
processes. Labeling design, specifications, storage, process and inspections methods for primary and
secondary packaging with utilization of barcodes and vision systems were interactively discussed.
NOVEMBER - Energy Savings
An education session took place
on November 7th 2012. Many
members braved the aftermath of
Sandy and the snow storm
to hear speakers present on the
subject of Energy Savings at the
GSK campus in King of Prussia.
The first speaker was Pierre
Salle, President/Managing
Director of DEKRA Certification.
He presented on the new
Superior Energy Performance
[SEP] and ISO 50001 energy
management system concepts
and certification programs.
The tools described in these
concepts have been successfully
implemented in other industries
and can help quantify savings
and return on investment.
The second speaker was Tom
Marnane, Sr. Project Executive
for STEAMGARD LLC.
Timothy L. Cole, P.E.
colet@ace-net.com
ADVERTISEMENTS
Applied Control Engineering, Inc.
700 Creek View Road
Newark, DE 19711
Main:
Direct:
Mobile:
Fax:
302 738 8800
302 738 1188 x317
610 368 0355
302 738 7381
www.ace-net.com
Tom explained with case studies
and lessons learned from his
experience, how to implement
substantial savings to a plant steam system. Steps to follow when evaluating a generation and distribution
steam system to identify and quantify opportunities for improvement and energy savings were discussed.