Bulletin

25th Anniversary Issue
Volume 18, Number 4
Fourth Quarter 2011
Pharma
Help us
Celebrate
25 Years of Innovation
Bulletin
Letter from the Editors —- Page 2
President’s Message --- Page 3
Chapter History—- Page 4
Brain Teaser—- Page 10
Current Event Coverage—- Page 11
Upcoming Schedule —- Page 16
Dr. Don’s Column —- Page 17
Join Us for our
th
25 Anniversary Gala
Saturday January 14, 2012
7:00 pm - Midnight
The Manor:
111 Prospect Avenue, West Orange, NJ 07052
Cocktail Hour:
Seafood Bar, Carving Stations, Hot & Cold Buffets, Passed Hors d'oeuvres
Champagne Toast
4-Course Dinner Reception:
Appetizer, Salad, Choice of 3 Entrees, Viennese Dessert Table
Premium Open Bar All Evening
Live Music, Dancing, Entertainment
Highlights of Chapter Memories & Distinguished Guests
RSVP
http://ispenjcjan142012-anniversarygala.eventbrite.com/
Letter from the Editors
Welcome to the 4th Quarter issue of Pharma Bulletin,
the newsletter of the New Jersey Chapter of ISPE.
We would be remiss if we did not begin with
recognition of the Special Edition nature of this issue
… congratulations to all on our 25th Anniversary as
the first Chapter of ISPE!!
This edition of our newsletter has some additional
features in celebration of this important anniversary
that we hope you will enjoy and appreciate. Included
are a history of the Chapter founding and formation
25 years ago, messages from a variety of current and
past members reflecting on the Chapter’s history and
future, and recognition of those who are spending
time and other resources to ensure the success of the
25th Anniversary Gala to be held on Saturday January
14, 2012 at The Manor in West Orange, NJ. Speaking
of the Gala, if you have not already done so, please
consider attending and perhaps supporting this
outstanding event with a sponsorship.
Included for your enjoyment is the first successful
response received to Brain Puzzler #1, presented in
Paul Malinowski
Secretary – Board of Directors
New Jersey Chapter of ISPE
Pharma Bulletin
the last issue of Pharma Bulletin (Third Quarter
2011). To encourage further readership and
involvement with our newsletter, the Chapter Board
has approved the offering of an ―economic incentive‖
for the first correct response received. Beginning with
Brain Puzzler #2 enclosed, the first correct solution to
the Brain Puzzler will receive complimentary
admission to the next regularly scheduled Chapter
meeting/event (a $75.00 value). So open this
newsletter to the Brian Puzzler and ―give it your best
shot‖ (and do it quickly to be considered for the
―economic incentive‖).
Of course, we have also included a variety of our
regular features and news items for your
consideration and hope that you will continue to be
involved and active in your chapter, the first Chapter
in the history of the ISPE!
On behalf of the entire Communications Committee,
we wish you a very Happy Holiday Season and a
Safe and Successful New Year.
Harry Segner
Chair- Communications Committee
New Jersey Chapter of ISPE
Page 2
President’s Message
It’s All About You
Hello again, this is your president speaking. So, last
time I took a trip down memory lane. The feedback
was quite positive. We like to reminisce. But, we are
a forward thinking organization, so we need to return
to our vision for the future.
Sure, you will read that we are always looking for
volunteers to get us where we need to be. The ISPE
is a very interesting and dynamic organization
because we are all volunteers; and volunteerism an
interesting dynamic. What is the motivation for you to
schlep 1 yourself to an evening event, committee
meeting, or board meeting after a long hard day of
doing what you are paid to do? While you ponder the
answer let me help you out. It’s because you care.
You care about what your company does. You care
about what our industry does. And, most importantly,
you want to contribute and make a difference.
No, this is not a Rah-Rah speech. I know YOU know
that, or quite frankly you would not be taking the time
to read this blurb when you are faced with so many
other things that are going on in your life. You are
reading this because you care, you know you do.
Now you’re thinking ―Oh great, another motivational
message for me to give up more precious time that I
just don’t have.‖ Well, of course I would love for you
to show up at every event and become a committee
chair, possibly even be my replacement. But, let’s get
real. You just don’t have the time. Wait, there are
other ways to become involved. There are other ways
to participate….other ways to become a participant, a
contributor, an ―ISPE volunteer.‖
It’s quite simple actually. As mentioned previously, we
are a forward thinking society, as should our industry be.
There are many changes coming at us. We are trying to
bring the international organization closer to home
through closer liaison with great Chapters like ours. We
are developing programs to get better local coordination
among operating companies, suppliers, academia, and
possibly regulators.
Pharma Bulletin
Gordon Leichter
We will soon have a new CEO for the society coming
on board. While we will all greatly miss Bob Best, a
new captain at the helm will steer the ship in a
different and new direction (okay, so I could not resist
a bulky metaphor). But, are you signed up to our
ISPE LinkedIn discussion? Twitter? Facebook? There
are so many ways to participate.
So, thank you so much for reading my quarterly
message. I will leave you with one thought and ask
for you feedback….. ”Volunteers do not necessarily
have the time; they just have the heart” ~Elizabeth
Andrew
______
1
Yiddish folk word for drag your tired butt somewhere
– ref –my mama.
Gordon Leichter, Ph.D.
President
NJ ISPE
[email protected]
Page 3
A Brief History of the NJ Chapter of ISPE
Several years ago, Bruce Eckman and a small group
of early ISPE members was asked to provide a
written history of the formation of ISPE’s first
Chapter, which was inaugurated in NJ in 1986. What
follows is an edited and updated version of that
document. We thank Bruce and those who remain
unnamed for their efforts to ensure we have a
record of this important event.
The International Society for Pharmaceutical
Engineering (ISPE) was founded in 1980 by a group of
individuals, a number of whom were from New Jersey.
One of the Charter Members, Jim O'Brien, is still active
in the Society and New Jersey Chapter today. During
the formative period, participation in ISPE required
travel to locations often remote from the heart of the
pharmaceutical industry here in New Jersey.
As 1986 arrived, a member from Merck, John
Stefanowicz recognized that ISPE meetings should be
more accessible to members near their places of
business. Thus the concept of ISPE Chapters was born.
New Jersey members created the first ISPE Chapter in
1986 with John as the first president. We had only
about 25 Chapter Members that first year. Our total
membership has steadily grown over the ensuing 20
years until we now number nearly 2000 Chapter
members including more than 100 student members.
Our Chapter, as the first, is proud of the many "firsts"
we count among our accomplishments. Based on
previous successful table-top shows and seminar
programs held by ISPE in New Jersey, the Chapter
initiated an annual Vendors Night in 1989 with
thirteen tables in the basement of the Tower
Steakhouse. Our membership had grown to almost
400 at this point. A few years later, on February 24,
1992, Bob Lechich and Joe Manfredi kicked off
ISPE's Student Chapter program with the original
Student Chapter at the New Jersey Institute of
Technology in Newark. The NJIT Student Chapter is
still among our largest, with about 50 student and
professors interested and active in the Chapter.
Chapter Meetings
The New Jersey Chapter follows a tradition of producing
8-10 local meetings each year. The program year starts
in September and now goes through our large
Professional Development Day (formerly called
―Chapter Day‖) late in the year. Fortunately most of our
members are situated within 100 miles of our meeting
spot, eliminating the need for extensive travel or
overnight stays
One of our longstanding primary goals has been to
serve all of our membership with interesting and timely
topics. We cover such diverse subjects as validation
techniques, facility design, management methods, and
The Chapter's first meetings occurred at the Tower
Steak House on Route 22 in Mountainside, New Jersey clinical supplies, right on through to lighter topics such
as Improving Your Memory. The New Jersey Chapter
with the first meeting taking place on September 23,
has always been proud to offer guided tours of various
1986. Early steering committee/board members
types of pharmaceutical facilities in the Metropolitan
included Mike Sisti, Wayne Sadowski, John Lee and
Jean O'Connor in addition to John Stefanowicz. Others Area. We have toured locations at Bristol Myers Squibb
who were involved included Elliott Goldberg and Karen in Hopewell and New Brunswick, Merck in Rahway,
Schering Plough (now Merck) in Union and Kenilworth,
McCullough. This author (Bruce Eckman) joined the
Hoffman La Roche in Nutley/Clifton, Becton-Dickinson
Chapter at the end of the first year of existence in the
in Franklin Lakes, Wyeth (now Pfizer) in South
spring of 1987.
Brunswick, NJ and Pearl River, NY, Novartis in East
Hanover and Summit, Catalent in Somerset and
In January of 1987, we had our most famous guest
lecturer; Lawrence Peter "Yogi‖ Berra who autographed Johnson & Johnson in Raritan.
pictures, answered questions and put in a good word for
We have also observed the operations of such
his son's flooring business. Another meeting that year
equipment manufacturing companies as Gettinge,
featured 20 of us having polite dinner conversation as
Cozzoli, Glatt Air Techniques, B Braun Biotech (now
the scheduled speaker did not appear.
Sartorius), US Filter, and A C Compact Press.
(A Brief History—Continued on Page 5)
Pharma Bulletin
Page 4
(A Brief History—Continued from Page 4)
Several unique tours over the years include the
Waksman Institute on the Piscataway campus of
Rutgers University, and the Pepsi Bottling Plant, also
located in Piscataway, which we toured as part of our
first Chapter Day. Visits to several microbreweries along
with wine-tasting, very well attended golf outings and
holiday parties served to create a well rounded and
popular program structure over the years.
Long Term Commitments
We have almost thirty members of our Chapter who
predate the formation of the Chapter (September 1986).
In addition to Jim mentioned previously, we have Jim
Agalloco, and Vic DiChiara who both joined the
organization in 1980. Don Sutaria and past president
Joe Manfredi both joined in 1981 and are still active.
Our Leadership
The New Jersey Chapter, originally named the North
Jersey Chapter, has had a total of twenty-five Chapter
Presidents. Three have gone on to become Chairman of
the International Society, including the current
Chairman, Randy Perez of Novartis. Many more
individuals from the Chapter have gone on to take
significant leadership roles in the ISPE on the local,
national and international level. We are proud to be a
part of ISPE’s first Chapter and are very pleased to be
able to celebrate our Silver Anniversary with you.
Originally prepared by Bruce Eckman, and edited by
Harry Segner, on behalf of the New Jersey Chapter
of ISPE.
Pharma Bulletin
Page 5
Thanks for the Memories . . .
Harry Segner For those of us who may not have been involved with ISPE
since the founding of the New Jersey Chapter (originally
―North Jersey Chapter‖ incidentally) in 1986, the past 25
years seem filled with stories and memories, some serious
and important, some more humorous or anecdotal, and
some ―legendary‖. We thought this would be a good time to
bring together the reminiscences of those who were
involved over the past 25 years to be shared with those of
us who can only look at those years with interest and
maybe a bit of disbelief.
We approached a variety of individuals who played
key roles in making our chapter what it is today, ranging
from our original Chapter President, John Stefanowicz and
one of the founders of ISPE itself, our own Jim O’Brien, to
the current Chairman of ISPE, Randy Perez (a New Jersey
Chapter Member) and Bob Best (soon to be retiring CEO
of ISPE) for their thoughts and comments. What you will
read below is their unedited (except for grammar and
punctuation) memories and opinions…..we hope you enjoy
it as much as we enjoyed gathering it.
John Stefanowicz (Founding President 1986-1987) I’ve been blessed that I have so many accomplishments
in my working career that I can look back on and feel
proud. I am particularly proud to have been the first
Chapter President in ISPE as well as the first New
Jersey Chapter President.
Over the years I have received a lot credit for
starting the New Jersey Chapter but it wouldn’t have been
possible with the help of Mike Sisti, Jean O’Connor, Wayne
Sadowski, and John Lee. With no funds and no guidelines
for us follow, we were fortunate to make the right decisions
that at the end of that first year we were as financially
stable as the International. Having Larry Berra and his
father Yogi as speakers really helped.
The examples we set and the initial guidelines we
developed have successfully led future Chapter Boards for
now almost 25 years. I congratulate and thank each
President, Officer, Board Member, Committee person, and
the general membership for their participation and
dedication so that we can all celebrate 25 wonderful years.
With regrets, due to prior commitments, I cannot
attend the January celebration. My wife is celebrating a
special birthday the following week (and I am forbidden
from saying how old) and we are booked on a cruise to the
Southern Caribbean. January in Jersey is not exactly a
Floridians idea of good weather anyway.
Enjoy the celebration and feel proud the Chapter
has reached this important milestone.
Pharma Bulletin
Bruce Eckman (Chapter President 1991-1992 and
1997-1998) I joined the ISPE in April 1988, at the behest of my boss,
Elliott Goldberg. We both worked at Jacobs Engineering in
Mountainside, and he thought our participation would be
good for business after a little talk with Dick Rooney who
was a salesman for Gettinge Autoclaves. Dick stopped in
for a visit, a soon after Elliott became the Chapter
Newsletter Editor and I, his able assistant. I don’t
remember what we wrote about, but in those pre-email
days, the newsletter was our only method of
communicating with the membership. We told everyone
when the next meeting was to be held and what happened
at the last meeting.
After we composed the newsletter, I got the 250300 one-color paper copies printed up in Cranford, and
we put mailing labels on and sent them out snail mail.
(The Chapter Manager was still a decade away.) The
Chapter kept growing so we must have been doing
something right. I remember ads were tough to sell in
those days and they still are. Keep up the good work
Lorraine, Harry, and everyone involved.
Elliott became President a year or two later
followed by Dick Rooney. I became Executive Vice
President when Dick was President and took over after
his untimely death. I think those of us around long
enough to remember still miss him.
I was elected President in 1991 and oversaw what
was then a 400 person Chapter. We thought that was big
but the best was yet to come. In the early 90’s we had
dinner meetings for the Board of Directors which often
featured the consumption of alcoholic beverages. Even if
we didn’t all agree on all the issues, we went home happy.
The board was largely AE and equipment suppliers in
those days, but we always found the occasional OwnerOperator type to round us out. Some early owners included
John Stefanowicz and Jim O’Brien of Merck, Ernie
Rottman from E.R. Squibb, Bob Lechich of Hoffmann
LaRoche, and Tom Craven of Schering Plough. Bob and
Jim are still active with ISPE today.
I have served as NJISPE Nominating Committee
Chairman for many years. John Stefanowicz asked me
one day to help him with this duty and I have stuck to it.
One interesting story is that of President Jim Livolsi. I
called Peter Bigelow, then of Wyeth Management,
asked him to give us a good person from their
organization to work with us. He volunteered Jim who
did validation for a living and served us well for several
years. He, along with Janit Buccella, Dominick Smith,
and Jenny Wong are past Chapter Presidents who
Page 6
pursued careers in the Validation/Regulatory Field. They
all helped to round out our Equipment/Facility design
strengths.
Our vendor tabletop shows have always been an
adventure for us, and were traditionally a source of
revenue for the Chapter. The first one was held in the
basement of the Tower Steak House on Route 22 in
Mountainside (across the parking lot from Jacobs, now
the parking lot for a movie multiplex). I think that thirteen
vendors bought tables that first year, 1989.
We have held ―Vendor’s Night‖ at a variety of
locales throughout Northern and Central New Jersey.
September’s on the Hill (now Colorado Café) in beautiful
Watchung was a nice, rustic location. We had table tops
at Steven’s Institute of Technology in Hoboken a few
years ago, one of our few true North Jersey urban
settings. The show occurred several times at our semipermanent meeting place, the Bridgewater Manor and at
two hotels on Davidson Avenue, Somerset- the Holiday
Inn and the Sheraton (now Double Tree).
Just this past fall we held our ―Technology
Showcase‖, as these nights have come to be called, at
the Hyatt New Brunswick. The show has been moved to
the fall from its original February/March timeframe for
reasons explained below. Thanks to Mark Schultz, who
has participated in many of these events, for helping jog
my memory about these events.
The most interesting and eventful Vendor Show
ever held was the 240 table extravaganza held at the
Meadowlands Convention Center in Secaucus. This large
turnout caught a few eyes across the river, as the Interphex
folks soon approached ISPE to form an alliance of our
great educational organization and their premier exhibition
skills. This arrangement proved beneficial to all, as ISPE
still provides speakers for their annual seminar program.
One of our contributions was to move our local Vendor
Shows to a time of year away from the Interphex spring
dates. We have settled on early fall after some trials and
tribulations and we also have individual tables at any event
where a vendor wants to appear.
If you are a vendor or supplier and can
document how many shows you have attended, please
let us know and we will be happy to mention the longest
running, most loyal supporter.
Joe Manfredi (Chapter President 1995-1996) At the time ISPE was being formed, I was heavily
involved with work at Sandoz for Jim O'Brien.
I often overheard Jim discussing this "new" society and
recall him mentioning to me that once things were
official he expected me to join. The concept sounded
good since I was young and just learning about the
industry, having come from the chemical process side. I
convinced my employer to pay for the membership,
primarily to keep Jim happy.
Unfortunately, things didn't go too well for our
new society with resulting organizational and financial
issues. In an attempt to turn the tide, Jim asked me to
co-chair a combined educational program and table top
show. We chose a small inexpensive hotel in Rochelle
Park, NJ for the event. Vic DiChiara and I were the
speakers for the educational program while Jim and I
planned the table top show.
The event was a big success both financially and
socially. We made enough money to put ISPE into the
"black" and through a stroke of luck the entire Yankee team
showed up for the show lead by Yogi Berra, whose son
was one of the exhibitors. The vendors and attendees
couldn't stop talking about our event for months afterward!
ISPE has provided wonderful networking
opportunities from the very beginning, even before the
term "networking" was coined. I'm thankful to have met
and interacted with the best people in the industry, most
of whom have become good friends.
Jim O’Brien (Founder of ISPE and Chapter President
1996-1997) As a founder of ISPE, I participated on the Board of
Directors for many years, and held several offices including
President and Vice President. I have participated as a
reviewer and chairperson for Pharmaceutical Engineering
for 25 years. I have also served on the Student
Development Committee, and on the steering committee
for local chapters. I have been on the Technical Document
Development Committee and am heading up the effort to
write the Laboratories Baseline® Guide. I have given talks
at the Chapter and national levels, and most recently
organized seminars in the U.S. and Europe on laboratory
design and construction.
I’ve also been closely involved in local Chapter
Bob Lechich, CPIP (Chapter President 1993-1994) development; in fact, I was instrumental in helping start
It is very interesting that through all the changes that the the first local ISPE Chapter, for New Jersey. We
pharmaceutical industry has gone through, ISPE and
decided that local Chapters were necessary to involve
the New Jersey Chapter in particular is still relevant to
more of our Members, because only 10% were
the industry and to its members… This anniversary is a participating on a national level. Local organization was
momentous occasion and reflects the dedication of a
also necessary because budgets were shrinking and
group of hard working professionals contributing to an
travel was limited. In addition, we wanted a better
important industry. My best to the Chapter.
mechanism for student participation and bringing ISPE
into the colleges.
Pharma Bulletin
Page 7
Don’t eliminate the input of others. Decisions are
easier to make with the appropriate input. The ISPE
experience, and participating in ISPE with its many
opportunities to network with other professionals, helps
people receive the input required to make decisions.
year. In response, a scholarship fund was initiated
starting at the Chapter level and extending to ISPE. In
the end, by several actions and the kind contributions of
so many of Dick’s friends and colleagues, Lisa stayed in
school and became the special education teacher that
she is today. That reflects all that is positive in this
organization as we celebrate our 25th anniversary.
In the late 80’s, Joe Manfredi approached me
about developing a program to get students actively
engaged with ISPE. Joe was focusing on NJIT and he
asked if I’d be interested in investing some time and
energy with the students at Rutgers. While some of the
Chapter leaders at the time dismissed the idea, we
continued onward buoyed primarily by Joe’s steadfast
stubbornness. Eventually, the chapter provided the
financial support to create Student Chapters at both
schools. This was a first for ISPE anywhere in the
world. Today, there over seventy ISPE Student
Chapters across the globe – in such places as China,
Ireland, Germany, Turkey, Australia, Sweden, and, of
course, New Jersey. Thanks Joe!
Many people are aware that ISPE presents
Chapter recognition awards each year at the Annual
Meeting. What many don’t know that back in the day,
these awards included criteria for Chapter athletic
contests and skit performances. That tradition was
ended in 1994, after our Chapter’s performance at the
1993 Annual Meeting. The theme of the Tuesday night
party was M.A.S.H. Our ―leaders‖ for that event were
Ritchie Malfa and Vic DiChiara, two fallen angels who
have moved on to other Chapters. There on the stage
surrounded by those of us who dressed as MASH
characters came Richie and Vic dressed in full military
regalia to lead us in a rousing rendition of ―God Bless
America‖. Needless to say, the other Chapters cried
foul, the ISPE NJ Chapter won the competition, and
ISPE decided no more competitions after the sore
losers complained too much. Isn’t it great to be part of a
Chapter that has such a rich legacy?
Jerry Guillorn (Chapter President 2003-2004) I remember how I became involved with ISPE: it was early
fall of 1993 and the "infamous" Jim O'Brien approached me
about helping him out on preparing a newsletter for an
organization to which he belonged, since he had been
receiving newsletters for a year or so that I was responsible
for while at EI Associates. I naively told him I'd meet with
him and a couple of his colleagues, Joe Manfredi and Bob
Lechich, to figure out what could be done to help out. I told
them how I was handling ours, with whom, costs, layout
and content thoughts, etc . . . BAM!! The next thing I knew
I was "volunteered" to develop the next newsletter for
ISPE, then joined in September 1993, and have been
involved ever since.
Then, as if that wasn't enough, I guess in about
'97 or so, I was again "volunteered" to "help" with a golf
tournament as a fund-raiser, during a time when the
Chapter's financial outlook was a bit dim. To keep the
costs down, I was able to negotiate a great deal with
Farmstead Golf Club (as I had run a couple of outings
there for some local organizations in my home town,
which is only a mile or so away from Farmstead, which
explains why it has been "way up there" for all of these
years!!). We had a great turnout, made some money for
the Chapter that got us back on a positive financial
track, and the rest is history - I've been involved with the
golf outing and it has been "way up there" ever since!!
So, my takeaways on my involvement with ISPE
are: be careful when you talk to Jim O'Brien; run if he
says anything that sounds like "volunteer"; but, once
you join, get involved!!! I have developed some truly
tremendous friendships, personal and professional,
within ISPE, and looking back on it, I wouldn't change
those decisions for anything.
I can't believe I'm saying this, but Thanks, Jim
Randy Perez (Current ISPE Chairman) for "volunteering" me! It's been a great 18+ years and I Congratulations to the New Jersey Chapter on achieving
look forward to more great times in the future!!
your Silver Anniversary. Even though most of my
involvement with ISPE has been with the international
Jon Tomson (Past ISPE Chairman 2001-2002) organization, I am proud to be a member of this Chapter. I
Probably the most significantly meaningful memory
have had the pleasure of speaking at or attending several
regarding the NJ Chapter involved Dick Rooney, a
Chapter events, and all of my experiences with you have
frequent seminar presenter, a Chapter Board member
been cordial and convivial. This always leads me to
and the man who encouraged me to become more
include you as one of the Chapters to consider for
involved with ISPE. Dick passed away unexpectedly in collaboration with either COP or International events. The
1990, a sad moment for many. It was also complicated combination of the GAMP pilot for our new conference
by the fact that his daughter was attending college at
format with the New Jersey Chapter Vendor Night was an
the time and he had no life insurance. It looked like Lisa example of how the local and international arms of ISPE
would be compelled to drop out just before her senior
can link to put on a successful event.
Pharma Bulletin
Page 8
On a historical note, it is worth pointing out that
members in New Jersey saw the potential of the
struggling entity that was ISPE in 1986, and was
foresighted enough to take a chance and form ISPE’s
first Chapter, growing alongside the International
Society to become the vibrant community that it is. The
fact that 20% of the current International Board of
Directors are members of this Chapter (including two
Chapter presidents) is testimony to that vibrancy.
So once again, well done on celebrating your
Silver Anniversary, and here’s to another successful
twenty-five years and a Golden Anniversary!
Bob Best (CEO of ISPE) While I am not able to be with you in person during
the celebration of your Silver Anniversary, I gladly
share my historic reflections at the end of my 27year tenure as ISPE President.
When I joined ISPE in 1985 the Society’s future
was in doubt, debts were mounting, and planning was well
behind schedule. And yet the issue I distinctly remember
being of gravest concern to the Board Chair during my
first meeting was that the Board Director responsible for
getting an ISPE Chapter launched had not made
progress.
Months later, thanks to some dedicated
members of the industry in New Jersey, there was
traction and by the next year ISPE had its first
Chapter . . . North Jersey.
Since then this Chapter has had a succession of
great Leaders, enabling the New Jersey Chapter to be
one of ISPE’s most accomplished. For example, ISPE
would not have Student Chapters had it not been for Jon
Tomson, Joe Manfredi, and others from this Chapter.
The Jersey Chapter has been an innovator for
several successful Chapter programs, later adopted by
other Chapters.
Many of the Society’s greatest contributors on
the International level started their ISPE journey
helping this Chapter. In fact, two of your most recent
leaders, Jim Breen and Gordon Leichter are now
members of the ISPE International Board.
God bless all of you for your great work and
best wishes for continued success.
Pharma Bulletin
Thanks to Our
25 Anniversary Gala Sponsors…
th
Over the past several months a small group of New
Jersey Chapter members , most notably Joe
Manfredi and Bob Lechich, have been working
tirelessly to put together what is shaping up to be an
extraordinary 25th Anniversary Gala Event in West
Orange, NJ. We would be very remiss if we did not
acknowledge and thank those sponsors who have
(as of this date, December 11, 2011), stepped up
with financial support for the Gala. We encourage all
of those who may wish to provide future sponsorship
to reach out to Joe and/or Bob to learn how to
participate. We look forward to seeing you on
January 14, 2012!
SPECIAL SPONSOR
Reed Exposition
SILVER SPONSORS
Aquafine
Commissioning Agents
DPR
PSC
Rotronic
Scott Process
Turner Construction Company
ANNIVERSARY SPONSORS
Bioclinica
Christ Aqua
EwingCole
Hach
IN-USA
MarCor
Page 9
BRAIN PUZZLER
As we mentioned in the Letter from the Editors, we are very pleased that the Chapter Board has approved the
offering of one complimentary admission to the next regular meeting of the NJ Chapter to the first person who
successfully solves the Brain Puzzler. (By way of clarification, a regular meeting is an event valued at $75.00, and
does not include events such as the Gala, Annual Golf Outing or other Special Event. In this case, that next event
would be the ―Build a Lab‖ event planned for a date to be determined in February). As before, the decisions of our
Secretary and creator of the Brain Puzzlers, Paul Malinowski, will be final.
So put on your logic and reasoning cap and take a shot at Brain Puzzler #2. Please address all responses to
Harry Segner at [email protected] and include a reference to Brain Puzzler #2 in the subject line so our email security doesn’t send you into cyberspace…..enjoy!
Yesterday after work, I overheard a sports-minded Young Professional (YP) discussing some arithmetic
problems with a friend. The problems seemed simple enough and the YP was getting all the correct answers.
For example, the first one was 25 + 8 and the YP said 33.
And the next one was 12 + 5 and the YP said 17.
The next was 35 + 13 and the YP said 48.
Then the friend posed the last two problems:
45 - 8. The YP said 47, but I thought the answer should have been 37.
The next one was 42 + 15. The YP said 43. I thought it should have been 57.
Her friend accepted both of those answers as correct. When I saw how the YP was dressed, I did too.
What was going on?
_____________
The first successful response to Brain Puzzler #1 in the 3rd quarter issue of Pharma Bulletin was submitted by
Karen J. Boyd, P.E.; LEED AP of Gilbane Building Company. We congratulate you for your sound reasoning and
thank all who participated (unfortunately for Karen, the Board did not approve the ―prize‖ until the November
Board Meeting, so we cannot make a ―financial‖ award this time).
The correct answer is as follows:
The Clever Young Professional is truly wise beyond her years. She places the following on the scale:
1 pill from bottle #1
2 pills from bottle #2
3 pills from bottle #3
… (continuing in like manner until)
10 pills from bottle #10
Based on the weight – it is then easy to determine which bottle has the defective pills.
If all the pills were the same 5 gms, the weight of the pills would be 275 gms.
Take the weight of all the pills and subtract 275 grams, this will yield the total number of defective pills
that are in the scale mix – which indicates the bottle # - which has the defective pills.
Pharma Bulletin
Page 10
Young Professionals Update
On Friday November 4 the NJ Chapter of ISPE held a
recruitment drive at the Bristol-Myers Squibb facility in
New Brunswick, NJ. The recruitment was held during
the BMS lunch hour outside the cafeteria. Chapter and
Young Professional Committee member Xavier Lopez
and Young Professionals Advisor and Board Member
Nancy Tomoney were present to answer questions
about ISPE for interested BMS employees and
contractors.
During the event nine interested potential
industry and young professional members were
engaged. A follow-up email was sent out several days
later to each of the interested parties. The Young
Professionals Committee hopes to continue to
participate in these recruitment efforts and is also
planning to host future combined social networking
events in the coming year.
“The Future Isn’t What it Used to be:
The Path Forward for Pharma”
On Thursday November 17, Dr. Dennis Gross made a
very informative and timely presentation to the members
and guests of the New Jersey Chapter at the
Bridgewater Manor. Dr. Gross, an Associate Dean and
Director at Thomas Jefferson University and Medical
College, provided his perspective on research
productivity and the drug and biologic/vaccine discovery
and development enterprise now and into the future.
As a former Senior Director at Merck Research Labs,
now again directly engaged on the academic side of
our industry, Dr. Gross brought many interesting
issues to the forefront during his remarks.
―Pharmerging Countries‖, strategic alliances between
the academic/university, pharma, biotech, CRO, and
Contract Site Management organizations and the
changing dynamics within the transition from branded
to generics were among his thought provoking topics.
We also heard from Tom Vorbach of 2nd Floor
Mission, a local charity dedicated to assisting at risk
youth with communications channels, of how his
organization is benefitting youth throughout the region
and the state. These presentations are periodically
sponsored by the chapter’s Community Affairs
Committee and are intended to expose worthwhile
charitable organizations to ISPE and us to their
missions as well.
Pharma Bulletin
Page 11
New Jersey Chapter Attends the
2011 Annual Meeting in Grapevine, Texas
More than 125 New Jersey Chapter members were
privileged to attend the 2011 Annual Meeting held at the
Gaylord Texas in Grapevine, Texas in early November. As
always, a fine program of educational content, networking
both nationally and internationally, as well as a fine variety
of social activities were enjoyed by all who were able to
attend this year. Please enjoy images of some of our
members during the 2011 Annual Meeting.
The New Jersey Chapter was honored this year to be
presented with two North American/South American
Affiliate Council awards - the Grand Prize Award for
Innovation in Student Programs and the First Place Award
for Innovation in Programs and Events. Congratulations to
all of the committee leadership and membership that made
these awards possible for our Chapter! We are proud to be
associated with such innovative and motivated individuals.
On a more ―fun‖ note, our own Nancy Tomoney, Director
and QC Rep to the Board and Liaison for the Young
Professionals of our Chapter, was selected in the annual
―Bingo‖ drawing as the recipient of a brand new I-Pad®!
Congrats also to Nancy on her good fortune!
Next year the Annual Meeting moves to the ―city by the
bay‖, San Francisco….if you have not attended an ISPE
Annual Meeting, this would be an ideal place to start and if
you have attended many, plan to join us again in 2012.
Pharma Bulletin
Page 12
Annual Meeting Awards Dinner
Pharma Bulletin
Page 13
Upcoming Chapter Events
“ Take some
January 14, 2012
25th Anniversary Gala
The Manor, West Orange, NJ
time from your
busy schedule
to mark these
important events
on your
February 2012 ―Build a Lab‖ Event
Location TBD
March 2012 Genzyme Tour and Dinner
Ridgefield, NJ
calendar !”
April 2012
R&D Event and Student Poster
Competition
Location TBD
WEBINAR PROGRAM SCHEDULE
The Professional Development and Certification Committee of
the New Jersey Chapter has embarked upon an exciting series
of webinars intended to provide educational growth for our
members and friends. The schedule of webinar events is in the
final stages of development and we anticipate publishing that
schedule in this section of future Pharma Bulletins. Stay tuned
for this important information and consider participation in the
Webinar program!
Pharma Bulletin
Page 14
Career Doctor Don Answers Your Questions
Don Sutaria is Founder and President of CareerQuest, located in New Jersey and New York.
Don earned his MS degree in Management from Kansas State University, an IE
(Professional) degree in International Management and Personnel Relations from Columbia
University, and obtained New York University’s postgraduate Certificate in Adult Career Planning and Development. A popular speaker and author, his latest book is titled, Career and
Life Counseling From the Heart (Your Career is a Pathway to Your Soul!).
Question: Lately I have heard a lot about career counseling and career coaching. How do I go about finding a
reliable and competent counselor?
John G. S. (Millburn, NJ)
Answer: Dear John:
Although many people use the terms 'career counseling' and 'career coaching' synonymously or interchangeably,
there are some subtle differences between them. Let me just clarify them. Note carefully that neither one of them is
a form of psychotherapy.
Career counseling is sometimes like giving advice from the sidelines, maybe even a little bit like Monday morning
quarter backing! It is a process which helps clients overcome deficiencies by providing answers and professional
advice. Counselors generally tend to use tests which measure aptitudes, interests and personalities.
Career coaching is more proactive, realizing that the only way to help people grow is to change their mental
framework, assist them in developing new practices and behaviors, and speak a new managerial language. It is a
process which helps clients develop proficiences by evoking excellence in them and allowing them to discover their
own answers. Coaches are more likely to work with the emotional aspect of career changes.
Did you ever try to obtain the name of a physician or surgeon through the phone book? It is a bewildering
experience and an exercise in futility! Weren’t you relieved when a neighbor, friend, or long-term resident of the area
with personal experience suggested a couple of names? That is a word-of-mouth endorsement.
Well, the process of selecting a career counselor, coach or advisor is no different! I would like to give you twenty tips
to enable you to form a good liaison with a person who would assist you with your career progression.
1. Get names from friends and past clients.
2. Select names from helpful books such as What Color Is Your Parachute? by Richard Bolles.
3. Perform a Google search, especially looking at web sites listing career counselors. The best one is
www.careercc.org.
4. Read at least a dozen professional biographies of the counselors and the nature of their clientele.
5. Call at least three counselors and discuss your requirements and the counseling process with them. If a
counselor does not give you at least 20 minutes of their time patiently, just skip to the next one.
6. Be willing to travel anywhere within a 100-mile radius for an effective coach; don’t be seduced by proximity!
( Continued on Page 16 )
Pharma Bulletin
Page 15
( Dr. Don continued from Page 15)
7. If you insist on a face-to-face meeting, be prepared to pay for a one-hour initial exploratory meeting. In urban
areas it is $150-$200 per hour.
8. Talk with the person who is really going to counsel you, not a salesperson. Find out the length and depth of
their experience.
9. Find out the duration of counseling, costs, and success rate. Typical examples are: Career assessment: 6-8
hours; Career change: 10-14 hours; Résumés and cover letters: 4-6 hours; Job search and change:
8-10 hours; Specialized career issues: 2-4 hours (per issue) (Example: Work-Life balance)
______________________________________________________________________________________
If you have a gut feeling that the personality match between you and the counselor is poor,
it is a danger sign-STOP!
______________________________________________________________________________________
10. Be wary if an upfront contract is needed. Prefer to pay on a per hour basis.
11. Do not use the phone book. It is a very poor way of finding good career counselors; it is like trying to find a
brain surgeon for a tumor!
12. Ask for references and testimonials. They are sometimes hard to get because of confidentiality reasons; try
anyway!
13. Ask for written reports of all tests and evaluations.
14. If you have a gut feeling that the personality match between you and the counselor is poor, it is a danger signSTOP!
15. Check out the counselor’s degrees and credentials but do not be seduced by them!
16. Prefer individual practitioners to group practice where responsibility can be diffused.
17. If a career counselor insists that your spouse or partner be with you at all times, beware of manipulative techniques for financial gain.
18. If you see a shared office with a person of another profession, beware of the front!
19. If a counselor offers you cut rate fees between $50 and $100 per hour, you will get what you pay for!
20. Watch for a falsely implied promise of getting you a job! This is not the function of a career counselor.
In closing, even after using all the above techniques to obtain the services of a career counselor, personal rapport
and success is not guaranteed! If you are not satisfied after two or three sessions, don’t hesitate to sever your
professional relationship with that counselor and start the selection process all over again.
[Special note: Please send your career-related questions to [email protected] and also visit
our website at www.careerquestcentral.com. Questions will be selected based on their contemporary nature and general interest. We regret we will not be able to send individual replies as in the past, because
of the large volume of domestic and international e-mails. Your patience and understanding are appreciated.]
Pharma Bulletin
Page 16
Thanks to our
2011 Holiday Event Sponsors!
The New Jersey Chapter is very appreciative of our many generous
sponsors, and especially would like to recognize those who made our
Holiday Party on December 8 th a very special event. Look forward to
more details on this event in the next issue of Pharma Bulletin and
have a wonderful Holiday Season.
Thanks to all who supported this year’s festivities!
Gold Sponsors:
INTERPHEX - Alycia Grenesko
LABREPCO - Richard Dougherty
Process Equipment Sales & Service - Steve Yelpo
Rotronic Instruments, Inc. - Steven Chenal
Bronze Sponsors:
AEC - Eric Ferguson
CRB Consulting Engineers, Inc. - Jeff Fedor
Fluid Technics, Inc. - Peter Sbrollini
PS&S - Lorraine Gallo
Siemens Industries - Mark Schultz
Pharma Bulletin
Page 17
A Special Thank You
to the
Sponsors of our Holiday Party
Pharma Bulletin
Page 18
NJC 2012 ADVERTISING / SPONSORSHIP PROGRAM
Advertising and Sponsorship represents an excellent opportunity to be identified as an industry participant and
a supporter of ISPE New Jersey Chapter’s Professional Programming. It is a particularly cost effective means
of increasing your firm’s visibility to the Chapter membership and beyond.
The ISPE New Jersey Chapter has a brand new Advertising/Sponsorship Program for 2012. In addition to our
―a la carte‖ items, various packages are available, which offer numerous advantages.
Platinum
$3,500
Newsletter - Business Card size - $250/issue
Gold
$2,200
●
Silver
$1,000
Bronze
$750
●
●
3 issues
2 issues
●
●
●
Newsletter - 1/4 page- $350/issue
4 issues
●
Newsletter - 1/2 page - $500/issue
4 issues
Website – 6 months - $750
●
Website – 12 months - $1,500
Event Sponsor - $350
●
●
●
●
4 events
3 events
2 events
●
Education/Training/Webinar Sponsor $250/event
Unlimited
Technology Showcase - $1,000
●
10% Discount on various other sponsorships
●
●
●
●
VALUE
$5,900
$3,950
$2,200
$1,250
SAVINGS
$2,400
$1,750
$1,200
$500
( Continued on next Page )
Pharma Bulletin
Page 19
NJC 2012 ADVERTISING / SPONSORSHIP PROGRAM (Continued)
Newsletter Advertising – The Chapter publishes a newsletter 4 times a year, highlighting recent and upcoming
events, educational programs, technical articles and general interest to the members. The newsletter is
published electronically to all current NJC members and others on our circulation list.
Business Card size - $250 per issue or $750 for 4 issues
1/4 page- $350 per issue or $1,050 for 4 issues
1/2 page - $500 per issue or $1,500 for 4 issues
Website Advertising – Your ad is visible to everyone who visits the NJC website.
6 months - $750
12 months - $1,500
Event Sponsor – The Chapter plans to hold approximately 4 on-site monthly events/meetings for 2012, featuring
networking opportunities and education content of general interest to the membership. Sponsors are recognized
during the program, on all ―e-blast‖ announcements of the event, plus acknowledgement in next quarterly newsletter
as part of the article on the event. Sponsors are furnished with a six to eight foot table in a highly visible location, where
they can set up an unattended Table Top display of their literature (restrictions may apply to off-site venues).
Admission to event is not included. Vendor Showcase, Holiday Event, Annual Golf Outing and Off-Site Facility Tours
are excluded from this price offer.
$350 per event
Education/Training/Webinar Sponsor - Conducted throughout the year, providing more in-depth education
content with less focus on networking. Logo/Listing on event announcements, plus acknowledgement in next
quarterly newsletter, as part of the article on the event.
$250 per event
Technology Showcase Participant - Once each year the Chapter holds a Vendor Table Top Exhibition. Gourmet
food, drink, and technical goods and services are on display, all combined to offer significant knowledge and
networking opportunities in a fun and energetic atmosphere. Various price/location levels are offered to exhibitors.
$1,000 level included with Platinum Advertising/Sponsorship package.
10% Discount on Various Other Sponsorships – From time-to-time the Chapter may hold various social events
where sponsorships may be offered or sponsorships may be available for a portion of an event, such as cocktail hour.
Sign-up now for your 2012 Advertising/Sponsorship opportunities:
http://ispenjc2011-12advertising.eventbrite.com
For additional information contact:
Lorraine Gallo
ISPE NJC Marketing Chair
[email protected]
732-584-0386
Pharma Bulletin
Page 20
The ISPE New Jersey Chapter
2011/2012 Board of Directors
OFFICERS
President
Executive VP
Vice President
Treasurer
Secretary
DIRECTORS
Engineering Rep
Pharma Rep
Vendor Rep
QC Rep
Young Professionals Rep.
Representatives at Large
Awards Committee
Comm. Commitee
EAC (Exec. Advisory Counsel)
Prof. Dev. & Cert. Committee
Prog. Committee, Co-Chair
Prog. Committee, Co-Chair
Marketing /Membership
Student Affairs Co-Chair
Student Affairs Co-Chair
Nominating Comm. Co-Chair
Nominating Comm. Co-Chair
Technology Committee
Past Presidents Committee
Community Affairs
Chapter Manager
ISPE Int’l Board Lisison
COP - Chair
(Communities of Practice)
Critical Utilities
High Potency/Containment
Biotechnology
C&Q
HVAC
GAMP
Sustainability
Sterile Process
Gordon Leichter, Belimed, Inc., 585/329-0497, [email protected]
Antonio Crincoli, Bristol-Myers Squibb, 732/227-5353, [email protected]
Scott Hickok, EMCOR Energy Services, 203/536-5219, [email protected]
Nandita Kamdar, PS&S, 732/584-0449, [email protected]
Paul Malinowski, Becton Dickinson, 201/847-7041, [email protected]
Jeff Fedor, CRB, 610/278-76441, [email protected]
John Perrigue, Johnson & Johnson, 732/524-6393, [email protected]
Andrew Harlow, SBB, Inc., 631/862-6261, [email protected]
Nancy Tomoney, PSC BioTech, 732/640-1177, [email protected]
Kaitlin Worden, Regeneron Pharmaceuticals, 914/298-5396, [email protected]
Lorraine Gallo, PS & S, 732/584-0386, [email protected]
Norman Goldschmidt, Pharma Engineering Advisors, 609/468-5704, [email protected]
Paul Melamud, Qpharma, 973/462-2653, [email protected]
Michael Picariello, Shire Human Genetic Therapies, 609/466-4118, [email protected]
Margaret O’Toole, Pfizer, 845/602-1325, [email protected]
Stephen Fowler, Process Equip. Res. & Consulting, 908/458-6478, [email protected]
Steve Fries, 908/892-9064, [email protected]
Harry Segner, Ewing Cole 215/923-2020, [email protected]
Paul Malinowski, Becton Dickinson, 201/847-7041, [email protected]
Norman Goldschmidt, Pharma Engineering Advisors, 609/468-5704, [email protected]
Michael Picariello, Shire Human Genetic Therapies, 609/466-4118, [email protected]
Jeff Fedor, CRB, 610/278-76441, [email protected]
Lorraine Gallo, PS & S, 732/584-0386, [email protected]
Joe Manfredi, GMP Systems, 973/575-4990, [email protected]
Robert Lechich, CPIP, Pfizer, 978/247-4513, [email protected]
Bruce Eckman, WBE Consulting, 732/704-9800 x226, [email protected]
Dragutin Stoicovici, Cozzoli Machine Co., [email protected]
John Perrigue, Johnson & Johnson, 732/524-6393, [email protected]
Dragutin Stoicovici, Cozzoli Machine Co., [email protected]
Stephen Fowler, Process Equip. Res. & Consulting, 908/458-6478, [email protected]
Caroline Shelly, Hunterdon Facility Planners, 908/393-9984, [email protected]
ISPE New Jersey Chapter, 908/393-9984, [email protected]
Gordon Leichter, Belimed, Inc., 585/329-0497, [email protected]
Antonio Crincoli, Bristol-Myers Squibb, 732/227-5353, [email protected]
Joe Manfredi, GMP Systems, 973/575-4990, [email protected]
Walter Fedick, Hoffman-LaRoche, [email protected]
Joe D’Amore, The Amore Group, 908/541-8104, joseph.d’[email protected]
Aaron Weinstein, IPS, 732/748-1990 x214, [email protected]
William Gantz, Bristol-Myers Squibb, 732/227-5275, [email protected]
Dragutin Stoicovici, Cozzoli Machine Co., [email protected]
Paul Malinowski, Becton Dickinson, 201/847-7041, [email protected]
Gordon Leichter, Belimed, Inc., 585/329-0497, [email protected]
Pharma Bulletin
Page 21
ISPE NEWS
FOR IMMEDIATE RELEASE
For more information contact:
Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
email: [email protected]
www.ISPE.org
ISPE Releases New Product Quality Lifecycle
Implementation (PQLI®) Guide Series
--New Good Practice Guides focus on Quality by Design principles and practices--
(TAMPA, FLORIDA, USA, 4 November 2011) – ISPE today announced that it will soon release Parts 1 and 2 of a new
series of Good Practice Guides on Product Quality Lifecycle Implementation (PQLI ®). These two new Guides comprise
the official first and second volumes of a planned series of PQLI Guides, which collectively address product and process
development through a Quality by Design approach that covers the entire product lifecycle. The series uses ICH guidelines Q8 (R2), Pharmaceutical Development, Q9, Quality Risk Management, and Q10, Pharmaceutical Quality System
as a basis, together with other relevant ICH guidelines.
―In recent years, both the industry and regulators have realized the importance of designing product quality into the
process itself. Quality cannot be added during the testing phase; it must be built-in by design,‖ said PQLI Project Manager John Berridge. ―The PQLI Guide Series gives industry personnel a roadmap for how to build quality into their processes, from product conception to continual improvement after the product is brought to market.‖
The first Guide in the series, Part 1 – Product Realization using QbD, Concepts, and Principles, is focused on the topics
of criticality, design space, and control strategy. Part 1 addresses product and process development, transfer to, and
establishment of, commercial manufacture using science- and risk-based approaches. It also includes an introduction
to, and overview of, the Guide sections.
The second Guide, Part 2 – Product Realizations using QbD, Illustrative Example, presents a small molecule case study
developed by the ISPE PQLI teams. The case study provides details of the application of the approaches to product and
process understanding using quality risk management. Part 2 also examines many case studies in the public domain
using ICH guidelines Q8 (R2), Q9, Q10, and other relevant ICH guidelines.
The two PQLI Guides will be available in print for the first time at the 2011 ISPE Annual Meeting, which will take place at
the Gaylord Texan Hotel in Grapevine, Texas, USA on 6-9 November, 2011. As a part of the Guide series release, ISPE
is extending a special offer to Members who register for Annual Meeting: any Member who purchases Part 1 of the
Guide will receive Part 2 free of charge, which amounts to a savings of US$145.
For more information on the ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement, Parts 1 and 2, or to order copies in either bound or electronic form, visit www.ISPE.org/PQLIGuides/Product-Realization-QbD-Concepts.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is
―Connecting a World of Pharmaceutical Knowledge‖ by providing Members with opportunities to develop their technical
knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate
with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a
global audience and 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.
Pharma Bulletin
Page 22
ISPE NEWS
FOR IMMEDIATE RELEASE
For more information contact:
Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
email: [email protected]
www.ISPE.org
ISPE Announces 2011 Award Winners
at Global Annual Meeting
(TAMPA, FLORIDA, USA, 16 NOVEMBER 2011) – ISPE announced its 2011 award winners at the Society’s Annual
Meeting held in Grapevine, Texas, USA 6-9 November. Recognizing the awardees’ contributions to ISPE and to the
pharmaceutical industry as a whole, Robert P. Best, President and CEO, presented the honors on behalf of the ISPE
Board of Directors.
―ISPE is fortunate to have among its dedicated Members, volunteers, and industry supporters this group of outstanding
contributors. All of this year’s honorees have uniquely contributed to the organization. In doing that, they have
positively impacted the pharmaceutical industry in some outstanding ways, and the world is a better place because of
them.‖ says Best. ―We are grateful for their work on behalf of ISPE.‖
Here are the 2011 Award winners:
Michael A. Arnold, RPh, received the Max Seales Yonker Member of the Year Award, honoring the ISPE Member
who made the most significant contribution to the Society during the past year. Arnold was awarded this honor for his
work leading the ISPE Community of Practice (COP) Council through major planning and restructuring efforts, as well
as for his involvement in re-designing ISPE’s education and conference portfolio for 2012.
Shinichi Osada and Jane Brown both received the Richard B. Purdy Distinguished Achievement Award, honoring
ISPE Members who have made significant, long-term contributions to the Society.
Shinichi Osada received the Purdy award in recognition of the high impact of his active involvement with the
Society both internationally and in Japan. Since 1994 Mr. Osada has served on ISPE’s International Board of
Directors. He was catalytic in introducing the Society’s COP concept to Japan, helping to strengthen the local
organization and creating a model for other Affiliates in forming local COPs. Mr. Osada also served on ISPE’s
Professional Certification Committee during its formative years, and he provided leadership on the Facility of
the Year Awards Committee as well.
Jane Brown received the Purdy award for her consistent, dedicated and passionate service to ISPE over a
period of 18 years. Ms Brown has served in numerous leadership roles, culminating in chairing the Board for
ISPE’s Carolina South Atlantic Chapter, and ultimately serving as Chair of ISPE’s International Board of
Directors. Since joining ISPE in 1993, Ms Brown has been deeply involved in membership development,
regulatory affairs, student and young professional development, the creation of new guidance documents,
university relations, and the North American/South American Affiliate Council. She has personally mentored
countless professionals, and she is currently leading ISPE’s volunteer development efforts.
The GAMP® Community of Practice was named the Committee of the Year to honor them for creating a
series of GAMP Good Practice Guides. Most recently, this group successfully pioneered ISPE’s new
conference structure for 2012 with their event, ―Improve Productivity with Risk-Based Validation,‖ held in the
US and Europe in September and November of 2011.
Pfizer was named Company of the Year. The organization was recognized for outstanding support as reflected by the
large number of Pfizer employees who are Members and volunteers for ISPE. Pfizer-based ISPE Volunteers have
engaged in significant active participation in the work of the Society through its many committees, councils, task teams,
Communities of Practice, programs, and activities.
Pharma Bulletin
Page 23
( ISPE News Release continued from Page 23 )
Kristin S. Murray and Stephen P. Reich received the Roger F. Sherwood Article of the Year Award for their article titled,
―Quality Risk Management (QRM) Tool Selection: Getting to Right First Time,‖ published in the July/August 2011 issue of
Pharmaceutical Engineering magazine.
The Japan Affiliate is ISPE’s Affiliate of the Year. The Affiliate was recognized for significant success in the areas of
membership development and retention. Affiliate Volunteers also produced a Guidance Document for worldwide distribution
that has been one of ISPE’s most downloaded documents ever. These accomplishments are especially noteworthy in light of
unexpected challenges the Affiliate faced due to natural disasters that took place in the region this year.
North American/South American Affiliate Council Awards:
The Boston Area Chapter was awarded the North American/South American Affiliate Council Platinum Grand Award for
Excellence and Innovation. This is the third year in a row that the Boston Area Chapter has received this honor. Runners-up
for this prestigious award included:
The San Francisco/Bay Area Chapter won the North American/South American Affiliate Council Platinum First Place
Award for Excellence and Innovation for medium-sized Chapters. This is the second year in a row that the San
Francisco/Bay Area Chapter has won this award.
The San Diego Chapter won the North American/South American Affiliate Council Platinum First Place Award for
Excellence and Innovation for small Chapters. The San Diego Chapter also received this honor in 2010, making this
the second straight win for the Chapter.
The Carolina-South Atlantic Chapter won the North American/South American Affiliate Council Grand Award for
Innovation in Membership Services.
San Francisco/Bay Area Chapter won the North American/South American Affiliate Council First Place Award for
Innovation in Membership Services.
The Boston Area Chapter won the North American/South American Affiliate Council Grand Award for Innovation in
Programs and Events.
The New Jersey Chapter won the North American/South American Affiliate Council First Place Award for Innovation
in Programs and Events for the second year in a row and the North American/South American Affiliate Council Grand
Award for Innovation in Student Programs.
The San Diego Chapter won the North American/South American Affiliate Council First Place Award for Innovation in
Student Programs.
The University of California San Diego Student Chapter is the 2011 Student Chapter of the Year Award Winner. They are
sponsored by the San Diego Chapter.
The International Student Poster Competition Award in the Graduate Category went to Diane Darlington of North
Carolina Central University, Carolina-South Atlantic Chapter, and the winner in the Undergraduate Category was Ryan Lojek
of Villanova University, Delaware Valley Chapter.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit Society of 22,000 pharmaceutical
professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is
―Connecting a World of Pharmaceutical Knowledge‖ by providing Members with opportunities to develop their technical
knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with
global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global
audience and 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.
Pharma Bulletin
Page 24
Pharma Bulletin
Page 25