www.ispe.org/greaterla
Published by the ISPE Greater Los Angeles Chapter
Serving Southern California’s
Los Angeles, Orange, Ventura and Riverside Counties
Editor: Kimberly Syre Email: ksyre@cox.net
Information: Phone 949-387-9046 and Fax 949-387-9047
NEWSLETTER
Volume 15, No. 2
IN THIS ISSUE
President’s Message
PAGES 1-2
January 20 Disposables COP
PAGES 3-4
ISPE West Coast Resource
Directory Deadline February 5
PAGE 5
December Meeting Photos &
Overview
PAGES 6-7
Full Day Pharmaceutical
Cleanroom Standards Class
February 17
PAGES 8-9
Chapter President Victor Lee thanks Scot DeAthos, Plant Manager/Site Leader
of Baxter Los Angeles for his presentation in December at Evening with Industry
Executives. See more photos and a meeting overview inside the newsletter.
ISPE Annual Meeting Review
PAGE 10
A Healthier Outlook for All
PAGE 11
ISPE Releases Oral Solid
Dosage Guide
PAGE 12
Golf Tournament Overview
PAGES 13-14
Annual Meeting Report
PAGE 15
Photos From Computer
Systems Class
PAGE 16
Chapter Board of Directors
PAGE 17
New Members
PAGE 18
ISPE Event Calendar
PAGE 19
I
President’s Message
by Victor Lee of Teva Parenteral Medicines
hope your new year is getting off to a great start and that you had a nice holiday season. I spent the downtime with my family’s newest edition, Ethan Lee, who was born in
September, and his brother Connor, our two year old. So, needless to say, even though
2009 brought its challenges, it also brought joy.
Now we are beginning a new year and are planning some really fun and educational
events. Starting this month, we have a meeting at my facility in Irvine on ISPE Disposables
Community of Practice (COP) and How to Implement Disposables into Your Facility. Our
speaker is Adam Goldstein, the Purification Manager, Clinical Operations for Genentech in
Oceanside.
Then in February we are offering another full day class. This class will be on Pharmaceutical
Cleanroom Standards and will be held at Grifols Biologicals in Los Angeles. Event flyers for
the January and February events are in this newsletter.
(continued on next page)
President’s Message (continued)
In March we are planning a St. Patrick’s Day social
event followed by our Annual GMP Expo (formerly
®
Sciences Group
Vendor Night) in May. Then inLife
June
we are hoping to
Southern California
organize a facility tour. If your 800-989-7575
faciltiy can host the tour,
please let our Chapter Manager,
Kimberly Syre know:
www.steris.com
ksyre@cox.net.
STERIS Corporation
Stacey Betts
STERIS
ISPE
Consumables
In the summer we will offer another
social event folExt. 23218
lowed by a full day class on HVAC
in September, the
stacey_betts@steris.com
Golf Tournament in October and
Evening with Industry
David J. Spencer
Executives in December.
Equipment
Ext. 23178
22-25 February 2010
Life Sciences Group
Southern California
800-989-7575
www.steris.com
Victor
®
STERIS Corporation
STERIS
®
STERIS Corporation
STERIS
®
STERIS Corporation
®
Conference
Applying Solutions
to Emerging
Industry Challenges
david_spencer@steris.com
We are featuring 2009 event photos
throughout this
newsletter. Enjoy the flashback and I hope to see you
at one of our upcoming events.
STERIS
Tampa
Grand Hyatt Tampa Bay
Tampa, Florida, USA
SEMINARS:
• Aseptic Processing
• Inspection Readiness
• OSD Guidance
• Lean Project Delivery
• Syringe Processing
• Containment Forum
• Technology Transfer
• Good Engineering and
Maintenance Practice
TRAINING:
HVAC for Pharmaceutical Facilities
Applying the GAMP®5 Guide:
A Risk-based Approach
to Compliant GXP Computerized Systems
Stacey Betts
Consumables
Ext. 23218
stacey_betts@steris.com
David J. Spencer
Equipment
Ext. 23178
david_spencer@steris.com
www.ISPE.org/2010TampaConference
Sponsorship and Table Top Exhibit
Opportunities Available
Life Sciences Group
Southern California
800-989-7575
www.steris.com
Stacey Betts
Consumables
Ext. 23218
stacey_betts@steris.com
David J. Spencer
Equipment
Ext. 23178
david_spencer@steris.com
Environmental Monitoring, Alarming, Reporting,
Validation/Mapping
Life Sciences Group
Southern California
800-989-7575
www.steris.com
Stacey Betts
Consumables
Ext. 23218
stacey_betts@steris.com
David J. Spencer
Equipment
Ext. 23178
david_spencer@steris.com
Life Sciences Group
Laboratories,
Stability &
Clean Rooms
Refrigerators,
Freezers
& Coldrooms
2
Warehouses
& Archives
Keith Loftin
(480) 657-9911
kloftin@veriteq.com
www.veriteq.com
Automated
Reporting
Flexible
Alarming
Redundant
Recording
Evening Meeting
ISPE Disposables Community
of Practice (COP) Update
and
How to Implement Disposables Into Your Facility
Wednesday, January 20, 2010
Location: TEVA PARENTERAL MEDICINES, INC.
11 Hughes, Irvine, CA 92618
Presenter:
Adam Goldstein, Purification Manager, Clinical Operations, Genentech Oceanside
Program Managers:
Victor Lee , Associate Director, Manufacturing Engineering & Equipment, Teva Parenteral
Medicines, Inc.
Paul Crissman, Principal, Biotechnical Solutions
Free To Attend for Teva Employees
Schedule:
4:30 - 5:30 pm Registration and Networking with Appetizers and Soft Drinks
5:30 - 6:30 pm 6:30 - 6:45 pm Presentation
Q&A Session
This session will cover the following items:
• Implementation of disposables
• Waste management for disposables
• Commissioning & qualification of facilities for disposables
• Practical aspects: How to get involved with the Disposables COP
TO REGISTER:
http://event-confirmation.com/ispela_meetings.htm
Sponsorships are available. Please email ksyre@cox.net to inquire.
8
ISPE Disposables Community of Practice (COP) Update
and
How to Implement Disposables Into Your Facility
Wednesday, January 20, 2010
Location: TEVA PARENTERAL MEDICINES, INC.
11 Hughes, Irvine, CA 92618
Presenter:
Adam Goldstein, Purification Manager, Clinical Operations, Genentech Oceanside
Program Managers:
Victor Lee , Associate Director, Manufacturing Engineering & Equipment, Teva Parenteral Medicines, Inc.
Paul Crissman, Principal, Biotechnical Solutions
Free To Attend for Teva Employees
Schedule:
4:30 - 5:30 pm Registration & Networking with Appetizers
5:30 - 6:30 pm Presentation
6:30 - 6:45 pm Q&A Session
Registration Form
Please Use Our On-Line System To Register: http://event-confirmation.com/ispela_meetings.htm
FAX YOUR REGISTRATION FORM TO: (949) 266-8461 or (949) 387-9047 with your credit card payment information
or to pay by check, first fax the form then mail your check at least one week prior to the meeting to ensure it is received
on time. Checks should be made payable to: ISPE Greater Los Angeles Chapter, 5319 University Dr., Suite 641, Irvine,
CA 92612. Call 949-387-9046 with any questions. Cancellation Deadline for refunds: January 13, 2010. Sponsors
receive 6’ table top, two free admissions to the meeting, recognition at the event, any future emails sent out and in the
Chapter newsletter.
❑ ISPE Member
❑ Non-Member
$25
$35 MEMBER INFORMATION
❑ Students - Free
❑ Meeting Sponsor
$500
First Name:
If Registering as a Member, Please Supply
Membership Information
ISPE Member:
Last Name:
Chapter Affiliation:
Company:
CREDIT CARD PAYMENT
Type of Credit Card
Circle One
Title:
Address:
City:
State:
Tel Number:
Fax Number:
E-Mail:
Zip:
Name on Card:
Credit Card #:
Exp Date:
Signature:
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Does Your Company Offer Services or Supplies to the
Pharmaceutical or Biotech Industry on the West Coast?
2010
ISPE WEST COAST
RESOURCE DIRECTORY
ALL ADS ARE 4-COLOR!
DEADLINE
FOR
SUBMISSION: FEBRUARY 5, 2010
Sponsored by the Following ISPE Chapters
GREATER LOS ANGELES
PACIFIC NORTHWEST
SAN DIEGO
SAN FRANCISCO/BAY AREA
The ISPE West Coast Resource Directory is an invaluable way for companies to
inexpensively reach decision makers and connect with those purchasing
products and services.
Available in Book, CD and Electronic Versions:
• Book version is mailed to nearly 2400 ISPE members on the West Coast.
• CDs are available at Chapters events.
• The electronic version is posted on all four ISPE Chapter Web sites:
http://www.ispe.org/greaterla
http://www.ispe.org/sandiego
http://www.ispe.org/sanfrancisco
http://www.ispe.org/pacificnorthwest
Reserve Your Ad Today by Visiting:
http://event-confirmation.com/2010 ISPE West Coast Directory Ad Payments.htm
5
Insight from Baxter’s Plant Manager/Site Leader
Overview of Scot DeAthos’ Presentation in December
O
by Kimberly Syre, Chapter Manager
ne of the most important meetings the Chapter offers each year is our Evening with Industry Executives. It’s our chance
to hear from a local business leader and gain some invaluable insight into running a successful pharmaceutical operation.
In December, Scot DeAthos, Plant Manager/Site Leader of Baxter Los Angeles, provided a presentation on Sustaining
Continuous Improvement. Scot spoke of the U.S. National Healthcare plan and how nearly all major manufacturers support a
revised plan but do want fairness in the plan. Any revised plan would increase costs so the need to reduce production costs and
improve cash flow have never been more important.
Implementing Lean Manufacturing requires a relentless elimination of waste. He used
some popular Lean manufacturing practices to improve cash flow. Some of the methods
included SMED, a lean production method for reducing waste in a manufacturing process
and Kanban, which is the practice of just-in-time production. The idea is to convert your
manufacturing process from running the current product to running the next product. By
utilizing these methods, companies can reduce scrap and improve yields.
He used his early experiences in the military to describe how he first got in the practice
of using Lean measures in the workplace. It was at this time that he learned 5S, a workplace organization methodology that uses five words beginning with the letter S: sort,
set, standardize, shine and sustain. By implementing 5S, the team has a clear understanding of how work should be done and ownership of the process is instilled in each
employee.
He expressed the vision of Lean: All employees treat the company as if they owned it
and strive to eliminate all waste from their processes.
(continued on next page)
VALIDATION
No Standard
Is Too High
For ABC.
COMMISSIONING
TRAINING
AUDITS
ALLEGHENY BRADFORD
CORPORATION
500 Airport Blvd, Suite 100 • Burlingame, CA 94010
Toll-Free (888) 242-0559 • Office (650) 320-1788 • Fax (650) 320-1789
www.propharmagroup.com
6
Regional Manager - Dori Carlson
Skids • Tanks • Valves • Pumps
Heat Exchangers • Filter Housings
1522 South Ave., Lewis Run, PA 16738
800-542-0650 • www.alleghenybradford.com
Insight from Baxter’s Plant Manager (continued)
Lean is a cultural change and leadership drives
culture. An effective team leader communicates
expectations, encourages risk taking and makes
it fun to participate. When recognizing the need
to improve, you must listen to feedback from others including employees, customers, peers and
competitors.
He indicated that an effective team leader would
set the example for others. Scot gave personal
anecdotes about using small but meaningful
gestures, like picking up trash when he sees it
around the facility, which eventually caught on as
a company-wide practice.
By encouraging risk taking and challenging the
status quo, it will build team confidence and an
empowered team will emerge.
In conclusion he stressed the need to:
• understand how your customers see you
• benchmark others for improvement ideas
• conduct post mortems to learn from successes
and failures
• revise processes and your behaviors based on
the learning
Thank you to Scot for sharing these valuable
tools for continuous improvement. Prior to the
presentation an extended reception and mini
trade show took place. Thank you to the sponsors of the event:
• Cannon Building Services
• CRB Engineers + Builders
• DPR Construction
• EwingCole
• Rudolph and Sletten
• Turner Construction
• Vertical Construction
• Xnergy
7
Full Day Class
Pharmaceutical Cleanroom
Standards
Wednesday, February 17, 2010
8:00 am - 5:00 pm
Location: GRIFOLS BIOLOGICALS, INC.
555 Valley Blvd., Los Angeles CA 90032
(Parking is Limited, Please Carpool if Possible)
Host: Estela Solano-Gomez, Quality Assurance Project Manager, Grifols Biologicals, Inc.
Program Managers:
John Clapham, Pharmaceutical Services Corp.
Brent Oswald, Business Development, Cannon Building Services Inc.
This class will cover the following items:
1. Sterility Control
2. Sterile Filling
3. Environmental Management (HVAC)
Presenter: Omar Hamidi, Baxter Bioscience, Mgr, Project Management Engineering
4. Isolators
5. Risk based validation and auditing
6. European Union Requirements
Breakfast and Lunch Provided for All Attendees
TO REGISTER:
http://event-confirmation.com/ispela_meetings.htm
Sponsorships are available. Please email ksyre@cox.net to inquire.
®
3
Full Day Class
Pharmaceutical Cleanroom
Standards
Wednesday, February 17, 2010
8:00 am - 5:00 pm
Location: GRIFOLS BIOLOGICALS, INC.
555 Valley Blvd., Los Angeles CA 90032
Host:
Estela Solano-Gomez, Quality Assurance Project Manager, Grifols Biologicals, Inc.
Program Managers:
John Clapham, Pharmaceutical Services Corp.
Brent Oswald, Business Development, Cannon Building
Registration Form
Please Use Our On-Line System To Register: http://event-confirmation.com/ispela_meetings.htm
FAX YOUR REGISTRATION FORM TO: (949) 266-8461 or (949) 387-9047 with your credit card payment information
or to pay by check, first fax the form then mail your check at least one week prior to the meeting to ensure it is received
on time. Checks should be made payable to: ISPE Greater Los Angeles Chapter, 5319 University Dr., Suite 641, Irvine,
CA 92612. Call 949-387-9046 with any questions. Cancellation Deadline for refunds: February 10, 2010. Sponsors
receive a 6’ table top, one free admission to the meeting, recognition at the event, and in the Chapter newsletter.
❑ ISPE Member
❑ Non-Member
❑ Meeting Sponsor
MEMBER INFORMATION
First Name:
Title:
CREDIT CARD PAYMENT
Type of Credit Card
Circle One
Address:
City:
Fax Number:
E-Mail:
If Registering as a Member, Please Supply
Membership Information
Chapter Affiliation:
Company:
Tel Number:
❑ Students $50
ISPE Member:
Last Name:
State:
$150
$210
$500
Zip:
Name on Card:
Credit Card #:
Exp Date:
Signature:
ISPE Announces 2009 Membership Award Winners
I
And Photos From Annual Meeting
SPE announced its 2009 award winners and recognized their contributions to the pharmaceutical industry and the Society. Robert P. Best, ISPE’s President and CEO, presented the
honors at the Society’s 2009 Annual Meeting held in November in San Diego. “ISPE is fortunate to have such dedicated Members who aspire to bring out the best in themselves, their colleagues, and the industry they serve,” said Best. “We are grateful for the many roles our active
Members serve and their contributions to the Society.”
Award winners included:
Jason Tang won the Max Seales Yonker Member of the Year, which honors the ISPE Member
who made the most significant contribution to the Society during the past year.
Gordon Farquharson received the Richard B. Purdy Distinguished Achievement Award. This
award honors an ISPE Member who made significant, long-term contributions to the Society.
Named after one of the Society’s founders and most accomplished Presidents, recipients are
considered to be Members of ISPE’s “Hall of Fame.”
Nuala F. Calnan, Alice Redmond and Stan O’Neill won the Roger F. Sherwood Article of
the Year Award for their article titled, “The FDA’s Draft Process Validation Guidance –
A Perspective from Industry,” published in the May/June 2009 issue of Pharmaceutical
Engineering magazine.
Poland Affiliate is ISPE’s Affiliate of the Year
Commissioning Agents, Inc. was named Company of the Year.
Istanbul University Faculty of Pharmacy is the 2009 Student Chapter of the Year
The Pharmaceutical Engineering Committee was named the Committee of the Year
The International Student Poster Competition Awards:
Graduate Category - Matthew J. Metzger of Rutgers University
Undergraduate Category - Aaron D. Rella of Stevens Institute of Technology
North American/South American Affiliate Council Awards
Boston Area Chapter - Platinum Grand Award for Excellence and Innovation.
San Diego Chapter - Platinum First Place Award for Excellence and Innovation for the third year
in a row along with the Outstanding Award for Innovation in Student Programs.
Carolina-South Atlantic Chapter and San Francisco/Bay Area Chapter - Platinum
Outstanding Award for Excellence and Innovation.
Chesapeake Bay Area Chapter - Grand Award for Innovation in
Communications.
Greater Los Angeles Chapter - First Place Award for Innovation
in Communications.
San Francisco/Bay Area Chapter - Grand Award for Innovation
in Membership Services and Innovation in Events, and the First
Place Award for Innovation in Student Programs.
Chesapeake Bay Area Chapter - First Place Award for Innovation
in Events and the Outstanding Award for Innovation in Student
Programs.
10
Carolina-South Atlantic Chapter - Grand Award for Innovation in
Student Programs.
Great Lakes Chapter - First Place Award for Innovation in
Student Programs.
A Healthier Outlook for All
O
Short Paper for Pharmaceutical Regulations MPE 8865
By Thomas Golden of Avrio Biopharmaceuticals
Company (BD) Biosciences, a leading developer of diagnostic
and research tools that advance the understanding of disease
and help improve patient care.
ne of the best business sectors for recovery in this current economy downturn is the Biotech Sector. The
biotech company Human Genome Sciences (HGSI),
has a promising lupus drug that will benefit mankind for the
potential cure of lupus. Human Genome’s joint venture with
GlaxoSmithKline (GSK) has benefited both companies from the
promising lupus drug cure.
As recently stated by BD Bioscience’s president Bill Rhodes,
“The stimulus package and the Obama administration’s change
in position on embryonic stem cell research will create momentum in the health care industry.“ BD Biosciences is continuing
investing into Research and Development, so that when the
opportunities become available BD Biosciences will be there at
the cutting edge of technology.
In the end of year 2006, HGSI and GSK entered into a codevelopment and co-commercialization agreement, with HGSI
having the responsibility of conducting the latest lupus latest
trials with assistance from GSK. This mutual agreement continues to present day. The companies share equally in the ongoing development costs, sales and marketing expenses, as well
as any profits from product commercialized under the current
established agreement. This is an example of a big pharmaceutical company teaming up with Biotech to improve their drug
pipeline. This agreement benefits the following stakeholders:
patients, the drug companies, the regulating bodies, and the
overall healthcare industry.
BD Biosciences provides grants to researchers to generate
new drug breakthroughs. BD Biosciences has also built a new
90,000 square foot animal free as well as antibiotic free manufacturing facility in Miami to support the future needs of the biotech industry. The facility, which will open in 2010, will produce
cell culture media designed to increase both the production
yields and the quality of biological medicines. These products
could help the biopharmaceutical industry save millions of dollars.
According to the Biotechnology Industry Organization (BIO), an
advocacy group for 800 biotech companies, an alarming amount
of these companies are down to their last six to twelve months
of cash. Some have gone out of business and others have
merged with or been acquired by other companies. Traditional
sources of support for new products came primarily from university endowments and pension funds that unfortunately lost value
over last two years. In addition, a significant amount of venture
capital has retreated from this industry.
The US is the leader in the Biopharmaceutical Industry because
the United States has the largest amount of entrepreneurs willing to take the risks of investing into the Biopharmaceutical
Industry with significant Return on Investments (ROI). The
power of US Biotechnology remains strong, even as the BRIC,
(BRIC = Brazil, Russia, India, and China) nations apply competitive pressure on the Biopharmaceutical sector.
There are many stakeholders who will benefit from the successes of all the above companies. The stakeholders include the
patients, the general public, the investors, the affiliated universities, and the National Institutes of Health (NIH). Others who will
benefit economically are the company’s share holders, the drug
companies’ management, the drug companies’ employees, the
architectural and engineering firms, the equipment suppliers, the
consultants, the regulatory bodies, and the overall healthcare
industry.
The road ahead looks promising, with healthy biotech companies well positioned to initiate projects or launch products as
early as next spring. There is good cause for optimism. The
industry will enjoy new opportunities because of the advances
in technology and an aging US population. Also, Congress is
currently debating a new health care plan that could give tens
of millions of Americans better access to health care in future
years, expanding the overall healthcare market.
Recovery for companies who participate and invest in the
biotech industry looks financially promising. Business growth
and development will continue to increase for companies in
this arena as the population ages and government and industry aspire to meet the needs of these groups. The numerous
stakeholders of the biopharmaceutical industry are positioned
to achieve financial gain as well as providing significant medical
contributions to the world.
Capital is also becoming available for the life sciences business
sector. President Obama gave the National Institutes of Health
(NIH) an amount of $10.4 billion as part of the stimulus package
that he signed in February, with the majority of the funding going
to a wide range of life sciences-related grants and research projects. There was a fifty three percent (53%) increase in biotech
funding from the first to second quarters in 2009.
Companies that invested in the health and medical testing
arena are looking particularly strong now because they have
solid data being generated from research and development.
Companies like Onyx Pharmaceuticals have a promising
research and development program with its later Phase trials for
a drug to treat cancer looking very positive. As part of a broad
clinical development program, Onyx’s cancer drug, Nexavar,
is being developed and marketed in collaboration with Bayer
Healthcare Pharmaceuticals. Amgen has an osteoporosis drug,
and BioCryst Pharmaceuticals has good data with regard to an
influenza drug fighting the current H1N1 pandemic. Another
company that appears to capitalize is Becton, Dickinson and
11
Bibliography
1. Human Genome Sciences and GlaxoSmithKline Announce
Full Presentation at ACR of Positive Phase 3 Study Results for
BenlystaTM in Systemic Lupus Erythematosus
2. BD Biosciences Advertisement “A Healthier Outlook” Fortune
07DEC09
3. Downloaded on 06DEC09 Onyx Pharmaceuticals web site
4. Downloaded on 06DEC09 Amgen web site
5. Downloaded on 06DEC09 Biocryst Pharmaceuticals web site
6. Downloaded on 06DEC09 Becton, Dickinson and Company
(BD) Biosciences web site
ISPE Releases its Oral Solid Dosage Forms Baseline Guide
Second Edition
I
SPE announced the release of its Oral Solid Dosage (OSD) Forms Baseline® Guide, Second Edition ― the latest ISPE publication reviewed by the US FDA.
“This second edition of the OSD Forms Baseline Guide is truly a compilation of the expertise and lessons-learned from some of
the most seasoned and experienced industry minds as they endeavor to assist their colleagues and improve the pharmaceutical
manufacturing process for oral solid dosage forms,” said ISPE President and CEO Robert P. Best.
This second edition updates content from the original Oral Solid Dosage Forms Baseline® Guide to current industry standards,
practices, and regulatory requirements. Specifically, it addresses the latest interpretation of GMP requirements, as well as a riskbased approach to regulatory compliance relating to the design, construction, and validation of the OSD manufacturing facility.
As with all ISPE technical documents, the OSD Baseline Guide, Second Edition utilizes a practical, pragmatic, non-theoretical
approach, giving the reader guidance on solving problems and serving as a valuable tool for addressing regulatory inspections
and compliance issues.
Highlights from the Table of Contents include Concepts and Regulatory Philosophy, Product Protection, Product and Processing,
Process Support and Utilities, HVAC, Electrical, Control and Instrumentation, Risk-Based Approaches to Commissioning and
Qualification, Cost Factors in OSD Manufacturing, Summary of Quality Risk Management Process, Risk Management Tools, and
HSE International Regulations and Standards Cross References.
Pharmaceutical
Engineering
Entire Certificate Online!
PAID
Classes begins in January
Fullerton, CA
Permit No. 487
Spring 2010
Certificate in
Nonprofit Org.
U.S. Postage
6766_Pharmaceuticalengineering_dwayne:layout 1 11/19/09 1:52 PM Page 1
The first public introduction of the guide will be at the ISPE 2009 Annual Meeting Session, “Why the New OSD Guide is Vital,”
held on 11 November in San Diego, California, USA. The importance of the new guide will in helping pharmaceutical manufacturing professionals avoid compliance issues, improve quality, and reduce costs.
Update the skills you need today with this convenient,
online program. Upon completion, graduates will know:
■ FDA regulations and the drug approval process
■ Quality control and assurance issues specific to
the manufacturing of drugs for mass production
■ Manufacturing and commercially distribute safe
and effective drug products
required for GMP compliant facilities
validation programs
California State University, Fullerton
University Extended Education
www.csufextension.org
ed or distributed at taxpayers’ expense.
09
■ How to interact with regulatory agents to explain
ty Extended Education
6870
, CA 92834-6870
Spring 2010
Pharmaceutical
Engineering
Certificate in
■ Integrated design elements and practices
12
I
Photos from Golf Tournament in October
t was a beautiful day on the course in October during the Chapter’s annual Golf Tournament. There were lots of winners
throughout the day. In addition to our winning teams showed here, there were several individual winners:
Closest to the Pin - Kevin Bauer, John Foran, Larry Lien and Doug Turner
Men’s Longest Drive - George Eichleay
Women’s Longest Drive - Mary Clare Smithson
Putting Contest - Keith Kenner and Mark Magnuson
The last place team, Control Air Conditioning received hula hoops and frisbees in case the players decide to take up a new sport!
A raffle including two flat screen tvs, golf items and many other great prizes were a big hit. Thank you to all who participated and
all of the hole sponsors.
1st Place Team - Duhig Stainless
2nd Place Team - Sani-Tech West
3rd Place Team - Siemens Building
Technologies
13
More Golf Tournament Photos
A Foster Wheeler Company
Susanne Lage’ Cost
Vice President,
Business Development
• Process Development
Emeryville, CA
& Scale-Up
Direct: 1.510.594.3003
• Critical Utility Design
sue.cost@biokinc.com
• cGMP Upgrades
www.biokinc.com
• cGMP Facility Design
• Debottlenecking
• Custom Process Equipment
• Commissioning/Qualification/Validation
14
E
Report from Board of Directors
Annual Strategic Planning Meeting
ach year your volunteer ISPE LA Board of Directors meets for a full day to plan
the events for the next year, establish a budget and discuss how to move forward. Each Board Member participates in the process. This year’s meeting was
held in August in a round table fashion with all ideas taken into consideration before
decisions were made. This brainstorming format worked really well and we hope that
you will be happy with what we have in store for you in 2010.
Please see the last page of the newsletter showing our 2010 schedule.
Julie Lees
Regional Manager, Southern CA
619.395.3748 cell
julie.lees@hyde-ec.com
www.hyde-ec.com
15
N
Photos from September’s Full Day Class
Computer Systems in the Life Science Industry
early 70 ISPE Members and B. Braun employees attended the Chapter’s full day class in September. Thank you to Pete
Klaes, Director of Duplex Business Unit at B. Braun in Irvine for welcoming the group and giving an overview of B. Braun’s
business to kick off the day. Following Pete was a teleconferenced presentation by Holly Baldwwin, a subject matter
expert on computer system validation, from B. Braun from Bethlehem, PA.
Process Control System Validation: from GAMP 4 to GAMP 5 was presented by Glenn Restivo and Dr. Fatime Ly both of
Siemens Centre of Competence Pharma in Spring House, PA. Using MES and EBR to Streamline Production and Quality
Operations was presented by Marc Puich of Werum America and Steve Thompson of SD Thompson (formerly of Amgen) presented Effectively Managing Information Resources in Highly Regulated Industries. Thank you to B. Braun and the speakers.
Building Great Things.
16
Officers
Name
ISPE LA Board of Directors
Company
Telephone
E-mail
President Victor Lee
TEVA Parenteral Medicines (949) 455-4807
victor.lee@tevausa.com
Vice President Lanie Geldert
EwingCole
(949) 417-6487
lgeldert@ewingcole.com
Treasurer Mohit Gupta
Watson Laboratories, Inc.
(951) 493-5123
mgupta@watsonpharm.com
Secretary Herric Chan
Amphastar Pharmaceutical
(909) 980-9484
herricc@amphastar.com
Networking Chair Dan Borton
Amgen
(805) 447-3004 dborton@amgen.com
Program Chair John Clapham
Pharmaceutical Services Corp (626) 792-1649
jclapham@biotech.com
Membership Chair Tom Golden
Avrio Biopharmaceuticals (805) 908-2230
tmgolden@aol.com
Student Affairs Chair Wilson Hsing
Anchen Pharmaceutical
(714) 360-9504
wilson.hsing@anchen.com
Director Justin Miller
Xnergy
(760) 438-7676
justinm@xnergy.net
Golf Chair Bill Neal
Duhig Stainless
(323) 263-7161
wneal520@ca.rr.com
Director Brent Oswald
Cannon Building Services Inc. (714) 630-9570
boswald@cannonbuilding.com
GMP Expo Chair Scott Tiedge
(949) 770-5899
stiedge@pacbell.net
Director Dona Tseng
Baxter BioScience
(818) 550-8575
dona_tseng@baxter.com
Director Stan Wendzel
BioRealty, Inc.
(949) 498-2391
stan@biorealty.com
Past President/Advisory Chair Stu Levenshus
M.D. Stainless Services
(562) 904-7022
stulevenshus@aol.com
Active Past Presidents: Michelle Gonzalez Amgen, Inc. (retired)
(805) 276-0418
atmg@adelphia.net
Matthew Atwong
(626) 398-3388
MatthewAtwong@yahoo.com
Denise Luckhurst DL Engineering
(818) 525-1827
denise@dlengineering.net
Paul Crissman
Biotechnical Solutions
(805) 844-1103
paul@biotechnicalsolutions.com
Chapter Manager Kimberly Syre
Attention To Detail
(949) 387-9046
ksyre@cox.net
Start Up Consultants
Products, knowledge, and quality
Valin delivers
Valin is the West’s leading supplier of fluid
handling, measurement, process heating,
filtration, motion control and automation
products for a wide range of bio-pharm and
bio-tech applications.
Call us today: 1-800-774-5630
Visit us at: www.valin.com
or email: moreinfo@valin.com
1701 E. Edinger Ave. Bldg J. / Santa Ana, CA 92705
Main: 714.953.1635 / Fax: 714.953.2126
Validation Equipment Rentals
Validator 2000s
Digi Dataloggers
RH/CO2 Sensors
Thermocouples
Pressure Transducers
HTR, LTR, CTR & Hart Baths
17
Validation and Equipment Rentals
888-433-MASY (6279)
www.masy.com
Welcome New Members September - December 2009
Scott Becker, Student, UCLA
Cory Bowman, Lead Validation Engineer, VALSPEC
Rebekah Campbell, Student, UCLA
Tao Chang, Engineering Manager, Pump Systems Inc
Wen-hsuan Chang, Student, University of Southern California
Davin Deb, Operation, Pharmaceutica North America
Alfonso Esparza, Account Manager, Siemens Building Technologies Inc
Gabriel Foong, President, Unbound
Clayton Gibbons, Sales Engineer, Siemens Industry
Kenneth Goebel, Senior Manager - PMO, Baxter BioScience
Mohsen Heidarinejad, Student, UCLA
Deniece Hicksted, Edwards Lifesciences
Biliang Hu, Student, University of Southern California
Yi-Han Huang, Student, University of Southern California
Jin Jang, Student, UCLA
Tarang Lal, Student, UCLA
Andy Lee, Software Quality Engineer, Edwards Lifesciences
Chi-Lin Lee, Student, University of Southern California
Garrett LeVan, Genie Scientific
Li Liang, Student, Keck Graduate Institute
Sun Yi Lim, Student, UCLA
Jamelo Mellejor, Manager, Pilot Plant, Watson Pharmaceuticals
Shih-Chun Ou, Student, University of Southern California
Jayesh Padhya, Project Manager, Sinpex Inc.
Cathleen Pantess, Project Manager I, Quality, Baxter Healthcare Corp
Jesse Rau, Student, UCLA
Erik Reinertsen, Student, UCLA
Joanna Ryther, Project Lead, Sinpex Inc.
Natalie Ryther, Project Lead, Sinpex Inc.
Kyle Seeman, Sr. Project Executive, Rudolph and Sletten, Inc.
Christopher Sheehy, Account Manager, Siemens
Pin Wang, Assistant Professor, University of Southern California
Ching-Jung Weng, Student, University of Southern California
Andy Wiedmann, Project Leader, Baxter Healthcare
Po-i Wu, Student, University of Southern California
Fady Youssef, Student, UCLA
Engineering
High Purity Liquid Handling
Products for Pharmaceutical &
Biotech Industries
Architecture
Process Technology
1-800-726-4835
Process Automation
Systems Integration
Construction Management
Nino Borsoni, PMP - Senior Vice President
borsoni@eichleay.com
c. 925.348.2157
p. 562.256.8660
f. 562.256.8699
Oscar Garcia
Chris Ballew
ogarcia@sani-techwest.com
cballew@sani-techwest.com
Technical Sales Representative
(323) 252-1110 Cell
Startup & Commissioning
Procurement
Technical Sales Representative
(805) 906-1533 Cell
Project Management
18
321 Irving Dr., Oxnard, CA 93030
www.sani-techwest.com
2010 ISPE Calendar
20 January
ISPE Disposables COP Update
and How to Implement Disposables into Your Facility
Presenter: Adam Goldstein, Purification Manager, Clinical Operations, Genentech
Location: Teva in Irvine
17 February
Full Day Class: Pharmaceutical Cleanroom Standards
1.Sterility Control
2.Sterile Filling
3.Environmental Management (HVAC)
Presenter: Omar Hamidi, Baxter Bioscience, Manager,
Project Management Engineering
4.Isolators
5.Risk based validation and auditing
6.European Union Requirements
Location: Grifols Biologicals, Inc.
22-25 February
ISPE Tampa Conference
17 March
St. Patrick’s Day Social Event
For Newsletter Advertising
Deadlines/Costs:
www.ispe.org/LosAngeles
7 April
Professional Development Training: Lean
Location: Amgen
20-22 April
INTERPHEX
_______________________________
6 May
GMP Expo Exhibit Show (formerly Vendor Night)
2 June
Facility Tour
7-10 June
ISPE Washington Conference
10 August
Social Event
22 September
Full Day Class: HVAC
7 October
Golf Tournament
7-10 November
ISPE Annual Meeting
Swan and Dolphin Resort
Orlando, FL
1 December
Evening with Industry Executives
ISPE
GREATER
LOS ANGELES
CHAPTER
5319 University Dr.
Suite 641
Irvine, CA 92612
949-387-9046
Fax:
949-387-9047
or 949-266-8461
For additional ISPE Educational
Offerings and Publications
www.ispe.org
ISPE is a global,
not-for-profit membership
organization that
provides education,
training, and technical
publications to
pharmaceutical
manufacturing
professionals.
Photos by Kimberly Syre
and Christy Pavano of CRB
19
All events subject to change due to availability
of venue and speakers.
For More Details please visit ISPE Los Angeles Web site
www.ispe.org/LosAngeles
and
ISPE’s Global Calendar
www.ispe.org