2013
ISPE Matters
SPRING/SUMMER
SPRING/S
R
S UMMER
E 2013
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............................... 1
Board of Directors................................ 2
25th Anniversary Celebration and
December Holiday Party ....................... 2
Social Networking ................................ 3
ISPE Upcoming Events ......................... 4
January Program Meeting..................... 4
March Program Meeting ....................... 4
Advertise in ISPE Matters .................... 5
April Program Meeting ......................... 5
Educational Meetings........................... 6
Vendor Exhibition ................................. 6
Volunteers Wanted ............................... 6
ISPE DVC Ski Trip ................................. 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.
From the President
By: Shannah Schodle, ISPE-DVC President
As our 25th Anniversary Year
comes to an end, the DVC
Board is poised to leverage our
success, embrace and learn from
our struggles, and accelerate
our impact on the life sciences
industry in our local community.
Through the years, we have been
able to address the needs of the
ever-changing environment and,
with cognizance, adapt to the
needs of our membership. Looking
forward, the rapidly evolving
environment of today requires
not just adaptation but foresight
of changes and overall alignment
with the global direction of ISPE
International and our leader,
Nancy Berg. The strides made this
year by our Chapter exemplify both
the benefits of expanding ISPE and
the future of things to come.
Over this ISPE DVC year, we’ve
attempted to lay the groundwork
for a new ‘status-quo’ of what
we provide and offer to support
our membership. Keeping open
minds as to how we can address
the challenges of both our owner
companies and suppliers has
allowed us to concentrate on
more specific needs of members
and offer new program formats
(and venues) that are more
focused on topics suited to
various demographics within our
chapter. Broadening the depth
of our involvement in the life
sciences industry has been at
the forefront of all we have done.
Understanding that ISPE isn’t
just the ‘big pharma’ society it
once was, requires a dedication
to augmenting membership with
biotechnology, medical device
and other focused therapeutic
segments. Addressing the needs
of not just engineering, but
regulatory, research and other
critical functions within our
membership firms has become a
goal of the chapter in addition to
ISPE’s strategic direction.
am privileged to have had the
opportunity to lead the board this
year and am confident that as we
start planning the strategy for next
year already, that our leadership
will continue to leverage the
alliances we’ve formed with other
societies, remain at the forefront
of member needs and propel
the society as the ‘go-to-place’
for quality education, holistic
relevant industry leadership and
networking to enrich their personal
impact on our industry.
I hope that you have been able
to participate in some of our
programs this year. We’ve not
only provided some new and
exciting topics and well respected
industry leading speakers, but
we’ve celebrated our past with the
company of our past presidents
and leadership at our 25th
Anniversary Celebration this past
December. We’ve hosted events
focused at engaging our young
professionals and students,
in addition to encouraging
networking for our more
experienced professionals.
I would like to whole heartedly
thank the DVC Board for all
their support and endurance
through this year; we approached
challenges head-on that
contributed to great success,
and we’ve laid the groundwork
for continued achievement of
the chapter. We’ve maintained
a balanced budget, increased
membership and accomplished
so many of our goals. I encourage
all of our membership to get more
engaged, provide their feedback
and continue to drive life sciences
in the DVC to preeminence as
an international leader. Enjoy the
summer and hope to see you all
soon!
As we conclude this ISPE DVC
year, I personally am grateful
to be amongst a Board and
Membership that contribute
excitement, innovation and
personal dedication to improving
and enhancing life sciences.
I say with great pride that I
Sincerely,
Shannah Schodle
ISPE- DVC Chapter President
ISPE-DVC Upcoming Events
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
ISPE-DVC - June Educational Event - Explosion Prevention
GSK, Upper Merion, PA
5 June
ISPE 2013 Annual Meeting: Quality Throughout the Product Lifecycle
3 - 6 November
Washington, DC USA
ISPE Matters 2013
ISPE-DVC
Board of
Directors
President
Shannah Schodle
CRB
Executive VP
Matthew McMenamin
GlaxoSmithKline
Treasurer
Renaldo Trancoso
Merck
Secretary
Alan Levy
Javan Engineering
VP, Programs
Matthew Snyder
GlaxoSmithKline
VP, Education
Emilie Pelletier
Laporte Consultants
VP, Marketing
Ellen Venezia
Foster Wheeler Biokinetics
VP, Young Professionals
Alex Myers
IPS
VP, Student Advisory
Jamie Angelastro
FlexPro Group
VP, COP Integration
Tom Kley
Cephalon
Past President
Robert Matje, CPIP
Endo Pharmaceuticals
Director
Mike Lanasa
Integra Life Sciences
Director
Randy Leinhauser
Merck
Director
Dennis Gross
Thomas Jefferson University
Director
Brian White
Integrated Project Services
Delaware Valley Chapter
25th Anniversary Celebration and
December Holiday Party
In December we celebrated our anniversary in conjunction with our annual holiday party. The event
featured a look back at some of the memorable events that the DVC has held over the past 25 years,
our leaders and the many notable achievements and awards given by and granted to the chapter. A
photo history was assembled along with an acknowledgement of all of our esteemed past presidents.
The multimedia presentation also included a video montage featuring some of our past presidents,
chapter members and other ISPE colleagues sharing their thoughts on our last 25 years as well as
looking forward to the next 25. The meeting, which was held, at the Crystal Tea Room in center city
Philadelphia, was attended by President and CEO of the ISPE, Nancy Berg. She spoke to the future of
the organization and how our chapter can contribute to the continuing success and growing relevance
to the pharmaceutical industry. Also, past president, Paul Whitby from Pfizer was honored as this
year’s recipient of the Buz Lange award given to a deserving member of the chapter who excels both
at work and in the community. DME Alliance Engineering Consultants was honored as the Chapter
Sponsor of the year for their continued support of and commitment to our society. The evening was
topped off by a champagne toast commemorating our past, present and future and was given by our
first president, John Cocco.
ISPE Matters 2013
Delaware Valley Chapter
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.
Architects
Engineers
Construction Managers
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Central Utilities | cGMP Compliance | Clean Rooms | Energy & Sustainability | EPCM | Labs | Mission Critical | Strategic Program Development
ISPE Matters 2013
Education
Conferences
Redefining the “C” in CGMP:
Ensuring a Reliable Supply of
Quality Medicines
11 - 13 June
Baltimore, Maryland
Biotechnology 2013: Looking
Ahead to the 4th Decade
27 - 28 August
Durham, North Carolina
Proactive Compliance
Conference
7 - 8 October
New Brunswick, New Jersey
Process Validation Conference
9 - 10 October
New Brunswick, New Jersey
ISPE 2013 Annual Meeting:
Quality Throughout the
Product Lifecycle
3 - 6 November,
Washington, DC
Training
Courses
Baltimore Classroom Training
11 - 12 June
Baltimore, Maryland
Durham Classroom Training
26 - 28 August
Durham, North Carolina
San Francisco Classroom
Training (Burlingame Area)
9 - 12 September
Burlingame, California
New Brunswick Classroom
Training
7 - 10 October
New Brunswick, New Jersey
Delaware Valley Chapter
PROGRAM MEETING
Consideration for the
Integration of Drug
Delivery Systems
JANUARY - We held our first program meeting
of the year, Consideration for the Integration of
Drug Delivery, Systems in January. The program
was presented by Glen Zimmermann, Director,
Sales & Marketing, Administration Systems and
Alvaro Estrada, Senior Director Strategic Program
Management & Technical Operations from West
Pharmaceutical Services.
The meeting highlighted a discussion on exploring
new technology and innovation in injectable drug
therapy devices. Details and insight was offered on
expanding regulatory requirements, global trends
effecting both the innovators and generics, and
possible improvements in injectable drug therapy,
manufacturing economics and overall patient care.
Special focus was given to global trends effecting
the both innovators and generics of integrated drug
delivery systems. Delivery systems will offer unique
opportunities for companies looking to differentiate
their drug product in this competitive global
environment.
The presentation was
well received and a series
of questions during the
Q&A period may lead to a
follow-up session featuring
specifics on the materials
and assembly options for
the novel drug delivery
systems presented.
PROGRAM MEETING
Challenges in the
Clinical Supply Chain
for Emerging Markets
MARCH - Our program meeting’s topic was
Challenges in the Clinical Supply Chain for Emerging
Markets presented by Steven A. Jacobs, MBA,
R.PH, President of Global BioPharm Solutions. The
interactive presentation focused on supply chain
challenges including clinical operations requirement
transparency, temperature control, customs clearance,
valuation and regulatory requirements which
have always been tasks that must be planned for
and executed consistently well. The presentation
highlighted biotech products and clinical studies
Washington, DC
Classroom Training
2013 Annual Meeting
5 - 6 November
Washington, DC
Knowledge, Skill and Passion
www.ipsdb.com
going into emerging markets like the BRICK (Brazil,
Russia, India, China and South Korea) countries,
and the African continent for vaccines and how to
work within these different cultures and address
the challenges of the available infrastructures.
The meeting was held at the Manayunk Brew Pub
continuing our offering of non-typical locations and
event offerings when possible.
ISPE Matters 2013
Advertise in
ISPE Matters
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
Delaware Valley Chapter
PROGRAM MEETING
Operational Variability & Uncertainties in Evolving
Biopharmaceutical Manufacturing Environments
APRIL - Our April program meeting explored the
Operational Variability and Uncertainties in Evolving
Biopharmaceutical Manufacturing Environments and
how to deal with these considerations. This current
hot-topic was presented by Niranjan Kulkarni, PhD, a
Lean Six Sigma Black Belt and Operations Specialist
at CRB Consulting Engineers.
The presentation focused on manufacturing
processes, especially in the biopharmaceutical
industry, that are highly variable in nature. This high
variability can be attributed to several characteristics,
such as, availability of resources - raw material,
people or equipment (transport or process), QA/
QC times, frequent scheduling changes, unplanned
downtimes, and inconsistent changeover times, to
name a few. One of the main problems dealing with
such operational variability is not knowing its source.
Furthermore, uncertainty in demands or supplies,
lead times, failures, ambiguity over the impact of
process/design changes, etc. add to operational
complexity. All the aforementioned issues can have
a negative impact on a plant’s productivity. The
presentation successfully introduced techniques that
could be employed to identify the sources
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on the manufacturing processes, throughputs
and consequently, profitability. Additionally, an
understanding of uncertainty in manufacturing
processes assists in mitigating effects of the same.
Application examples and case studies were used
to highlight these techniques. This is another topic
then lends itself to deeper dives into specific areas of
investigation and evaluation.
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ISPE Matters 2013
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
EDUCATION MEETINGS
Case Studies on ISPE Guidance
APRIL - On April 3rd at the Desmond Conference
Center in Malvern, PA, an Education session
entitled ‘’Case Studies on ISPE Guidance” was
held. Two presentations were given on the subject
Paul Daniel, a Senior Compliance and Regulatory
Instructor for Vaisala Inc., presented a case
study on the ISPE Good Practice Guide: Cold
Chain Management. The presentation focused
on determining where to place sensors when
performing mapping studies.
Hite Baker P.E., a Principal Process Engineer
for DME Alliance Engineering Consultants Inc.,
presented ‘’Highlights of an Isolator-Based Sterile
Facility Design for Compliance and Efficiency’’
which described how the ISPE Baseline® Guide
Volume 3: Sterile Product Manufacturing Facilities
(Second Edition) can be used when designing a
sterile process. The presentation gave an historical
overview of the facility design surrounding a sterile
process and detailed regulatory, technology and
market trends.
Vendor Exhibition
FEBRUARY - Instead of our usual program in
February, we had our Annual Vendor Exhibition.
The event was held at the home of the Philadelphia
Phillies, Citizen’s Bank Ball Park. The event featured
115 industry equipment and service providers and
was attended by over 550 chapter members and
guests. This continues to be the most successful and
popular event on our annual calendar. In addition to
the chance for supplier interaction and networking
with colleagues; we presented our celebratory 25th
Anniversary video in continued recognition of our 25 years as a chapter, we had a surprise appearance by
the Phillie Phanatic who passed out Phillies souvenirs to some lucky attendees, multiple door prizes were
awarded by the chapter and several of our vendors and a few Middle School teams from the Philadelphia
area Future Cities competition were invited to display their projects. If all of this industry exposure,
membership interaction and good food wasn’t enough, we also enjoyed a behind the scenes tour of the
Philadelphia Phillies clubhouse, dugout and training facilities.
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ISPE Matters 2013
Delaware Valley Chapter
ISPE DVC Ski Trip
ISPE-DVC Young Professionals Committee hosted its annual ski trip on
Friday, February 1st, at Blue Mountain in Palmerton, PA. Twenty one
people from member companies, including GSK, Sanofi, CFS Solutions,
CTB, IPS, and Hargrove, showed up for the event. The event was
sponsored by Siemens, represented by Mark Schultz, who provided
lunch, and Hargrove Life Sciences, represented by Brian Lipko, who organized the event and provided coffee
and donuts for breakfast. This year’s trip was a great success and next year’s trip should be even better.
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