Outgoing President's Message by wuxiangyu


									                   Published by the ISPE San Diego Chapter
    Serving Southern California San Diego to Orange County
                 Editor: Kimberly Syre Email: ksyre@cox.net
   Information: Phone 1.949.387.9046 and Fax 1.949.387.9047
                                                                 NEWSLETTER • Volume 17, No. 2 • www.ispe.org/sandiego

  ISPE’s 2007, 2008 and 2009 Platinum First Place Award Winner for Excellence and Innovation


Outgoing President’s Message
                PAGES 1 & 2

            Join Us 12 August
        That 70s Vendor Show
   With Free Novartis Seminar
                  PAGES 3-4

Spring Golf Tournament Photos
                     PAGE 5

           Padre Game Photos
                     PAGE 6

 How to Avoid and Respond to
             FDA 483 Letters
                  PAGES 7-9

       Student Poster Contest
                    PAGE 10

    Overview of Ultra Efficient           Photo of Kinetics and Siemens Building Technologies teams in the Spring Golf Tournament at La
  Chilled Water Plants Meeting                                    Costa in May. See additional photos on Page 5.
                      PAGE 11

       Announcing New Board
                   PAGE 12
                                                     Outgoing President’s Message
           New Member Lunch
                   PAGE 13                                     by Don Holden of CRB

                                            s my term as the San Diego Chapter President has come to an end, I would like to
         ISPE Career Sources
                    PAGE 14                 thank all of you for your support of our local Chapter. It has been a privilege serv-
                                            ing you for my 2009-2010 term. I know that as I leave, the chapter will be left in very
   ISPE Electronic Documents         capable hands. As you know ISPE is driven by its Members so along that line we encourage
                    PAGE 15          each and every one of you to have as full a share as possible. Not only is ISPE a great place
                                     to network, but it’s a great resource for knowledge.
      Welcome New Members
                  PAGE 16
                                     On a local level the Board of Directors attempts to plan a year of educational activities that
   Photos of Wild Animal Park        will help you in your careers and to achieve your goals. Many hours are put in by those on
                       Event         the Board, so I would like to personally thank them. Of course along the way we find time to
                    PAGE 17          have fun.

    2010 ISPE Event Calendar
                    PAGE 18
                                                                                                                    (continued on next page)
                                                          President’s Message
I would also like to encourage all our Chapter Members to reach out and get involved with your local Chapter. We are looking for
those who would like to volunteer to serve on committees and eventually be a part of the board of directors. Please let any of us
know if you would be interested.

I would also like to thank all those who have been sponsors of our events, companies that have allowed us to use their facilities
and the employers who allow the employees to be a part of this organization.

On an international level, ISPE continues to make great strides to provide you with great value for your membership. At our
recent Washington DC conference we learned of a number of new and improved things that will benefit you like:

•    A new and improved Web site with easier search functions

• The 19 COPs are developing new web pages and search engines which will define each COP’s core competencies and make
it easier to access information

• One or two free webinars will be offered per month for ISPE Members only. So look for the ‘orange’ banner and a message
that may read ‘Free Gift for ISPE Members”

•    A new Career Solutions webpage

                                                                                       •       Young Professionals Connections

                                                                                       So I believe in the coming months and year you will continue to
                                                                                       see how ISPE is working to provide benefit and value to you!

                                                                                                                       Don Holden

                                                                                                STERIS                   ®       Life Sciences Group
                                                                                                                                 Southern California                                   STE
                                                                                                STERIS Corporation               Stacey Betts                                          STERIS
                                                                                                                                 Ext. 23218
                                                                                                                                 David J. Spencer
                                                               619.395.3748 cell
                                                                                                                                 Ext. 23178
    Julie Lees                                         julie.lees@hyde-ec.com                                                    david_spencer@steris.com
    Regional Manager, Southern CA                            www.hyde-ec.com

                              Products, knowledge, and quality                                                                                                         Engineering
                                                Valin delivers                                  STERIS                   ®       Life Sciences Group
                                                                                                                                 Southern California                    Architecture
                               Valin is the West’s leading supplier of uid                                                       www.steris.com                  Process Technology
                               handling, measurement, process heating,
                                                                                                                                                                Process Automation
                                ltration, motion control and automation                         STERIS Corporation                   Stacey Betts                                      STERIS
                               products for a wide range of bio-pharm and                                                            Consumables                Systems Integration
                               bio-tech applications.                                                                                Ext. 23218          Construction Management
                                                                                           Nino Borsoni, PMP - Senior Vice President                      Startup & Commissioning
                                                                                                                                     David J. Spencer
                                      Call us today: 1-800-774-5630                        borsoni@eichleay.com                      Equipment                         Procurement
                                          Visit us at: www.valin.com                       p. 925.363.3112                           Ext. 23178
                                      or email: moreinfo@valin.com                         f. 925.689.7006                           david_spencer@steris.com  Project Management

                 1701 E. Edinger Ave. Bldg J. / Santa Ana, CA 92705
                      Main: 714.953.1635 / Fax: 714.953.2126

                                                                                                STERIS                   ®       Life Sciences Group
                                                                                                                                 Southern California                                   STE


    10950 N. TORREY PINES RD.
          LA JOLLA, CA
                                    JOIN US FOR THAT 70S

                                         VENDOR NIGHT
                                              FREE TO ATTEND
                                        CASH PRIZE FOR BEST 70S LOOK

                                FREE SEMINAR
                                2:00 - 3:00 PM
                                CASE STUDY OF NOVARTIS SOLAR PROJECT
                                BY DIANE JOHNSON, DIRECTOR OF ENGINEERING
                                NOVARTIS VACAVILLE

                                3:00 - 7:00 PM
                                EXHIBIT SHOW
                                COMPLIMENTARY APPETIZERS
                                LOTS OF DOOR PRIZES

                                FREE TO ATTEND
                                FOR NAME BADGE, EMAIL YOUR NAME & CONTACT INFO TO:
                                                       VENDOR NIGHT
                                                                       ExHIbIT SHOw
                                     THuRSDay, auGuST 12, 2010
                                     aT HIlTON la JOlla TORREy PINES                                              e:
                                      10950 North Torrey Pines Rd., La Jolla, CA 92037 (858) 558-1500
                                                                                                             h  at
                                                                                                           T   h s
FREE SEMINAR                                                                                                 T 0    r
                                                                                                              7 do
Case Study of Novartis Solar Project
                                                                                                              en w
2:00 - 3:00 pm                                                                                              V ho
Presenter: Diane Johnson, Director of Engineering, Novartis Vacaville
Program Managers: Marcella Goodnight of Genentech Inc. and Jerry Yaddgo, PE of Biogen Idec

                         Cash Prizes for Best Dressed Table and Best Dressed Attendee
               All tables are 6’ long by 2.5’ wide. Maximum Height 60”/Maximum Width 72”.
                        Everything must fit on your table top (not on the floor or wall).

                      VENDOR NIGHT REGISTRATION
                                                                                                        PINK SLIP PARTY
 ❑ FREE TO WALK THE SHOW & VISIT EXHIBITS (3:00 - 7:00 pm)                                          Please bring your resume
                                                                                                       to post for potential
 ❑ FREE FOR ALL Case Study of Novartis Solar Project (2:00 - 3:00 pm)                                   employers to see.
 ❑ $610 Table Top      Table Choices Given Based On Order Paid
                                                                                                         Please bring your job
 For an immediate receipt, use our on-line registration:
 http://event-confirmation.com/ispesd_meetings.htm                                                      postings. A free table is
 Registrations can also be faxed using this form with credit card payment.                              available for employers
 Fax to 949-266-8461 or 949-387-9047. ISPE SAN DIEGO CHAPTER                                               with job postings.
 5319 University Dr., Suite 641, Irvine, CA 92612. Chapter Hotline (800) 869-9621
 or (949) 387-9046. ISPE San Diego Chapter Tax ID#33-0551783.                                           Contact Kimberly Syre to
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                                          Spring Golf Tournament Photos
                                    Photos by Kimberly Syre, Chapter Manager

                                    In A Sea
                                    Of Change,
                                    Some Things
                                    Are Constant.
                                                           ALLEGHENY BRADFORD

                                    Regional Manager - Dori Carlson

 Skids • Tanks • Valves • Pumps     1522 South Ave., Lewis Run, PA 16738
Heat Exchangers • Filter Housings   800-542-0650 • www.alleghenybradford.com
                                  Memories of Padre vs Dodger Game in July
                                           by Stacy Sutton of Althea Technologies
                                        Photos by Kimberly Syre, Chapter Manager

                                       here is only one way to usher in the summer season – the San Diego Chapter
                                       Annual Baseball Social Event! This is our fourth year of celebrating the boys of
                                       summer. ISPE Members, the Board of Directors and the Chapter’s newly orga-
                                 nized Advisory Council met to see the San Diego Padres take on local rivals, the Los
                                 Angeles Dodgers. The group was in a private area overlooking the Padre bullpen.
                                 We won’t mention the final score…

                        2011 Facility of the Year Awards
                             Call for Submissions
                                 DEADLINE OCTOBER 8, 2010
                Submission for the 2011 Facility of the Year Awards Program is now open.

The Facility of the Year Awards (FOYA) program recognizes the accomplishments, commitment, and dedica-
tion of companies worldwide with innovation and advancement of pharmaceutical manufacturing technology.
           Send your Intent to Submit Form today if your company has a new or renovated facility.

             For additional information about the Awards program and submission procedures
                           contact Ryan Smith, ISPE Communications Manager
                                      by tel: +1-813-960-2105, Ext. 277
                                              or rsmith@ispe.org                                                  6
            How to Avoid and Respond to FDA 483 Letters
     for Temperature, Humidity and other Controlled Environments
             By Ken Appel of Veriteq, a Vaisala Company

        o cGMP manufacturer wants to receive a Form 483                 Sample Deviation #2
        letter (Notice of Inspectional Observations). In such           To a blood bank:
        stringently controlled industries as pharmaceutical and         “Failure to have quality control procedures and follow those
biotechnical development, manufacturing and warehousing,                procedures for periodic tests of containers to maintain proper
receiving a list of deficiencies can feel like a heavy blow to          temperature...as required by 21 CFR 606.160(b)(5)(iv)...”
your quality system. Worse, with the 2009 increase in enforce-
ment staff 1 and the September 2009 change to the response
time—now 15 days—the FDA appears to be ramping up its
enforcement mandate.2

The following article shows three excerpts from some of the
more common “observations” noted in Form 483 Letters dur-
ing 2008-2009. (The names have been left out in this article,
but are a matter of public record).3 Each of these deviations
involved environmental conditions (temperature, humidity, etc.)
in a variety of cGMP settings; they range from failure to prop-
erly validate containers for human cell and tissue products to
a lack of temperature records in an aseptic processing area of
a drug manufacturing facility. None of the deviations excerpted           There must be documented evidence at any point in time that
here are unique, but all are avoidable.                                    an environment was within its recommended specifications.

After the excerpts, we’ll outline some best practices of a 483          Sample Deviation #3
response, providing you with a 10-point checklist that should           To a major manufacturer of OTC Pharmaceuticals:
make that 15-day time limit more manageable, and some links              “Failure to establish and maintain procedures to adequately
for further research. Finally, we’ll look at ways to simplify and       control environmental conditions, as required by 21 CFR
automate monitoring, alarming and reporting on FDA regulated            820.70(c). Specifically, temperature conditions within the
environments. Options range from low-tech manual methods,               aseptic processing area are not being documented to ensure
to hybridized systems that combine written and electronic               such conditions are consistently within established specifica-
methods of documentation, to fully automated systems.                   tions... For example, during the inspection we observed that
                                                                        your firm was recording the relative humidity (RH) in the pro-
                                                                        cessing room, but not in the sterilization chamber. We also
                                                                        observed that your firm was not maintaining or reviewing the
                                                                        temperature recorder charts generated during your sterilization
                                                                        process of [product x]...”

  Many opportunities are available to tighten up documentation
     of controlled environments with modern technology.

Sample Deviation #1
To a Contract Pharma manufacturer:
“Requirements for stability testing of drug products are not
being met. For example, you do not have, as part of the stor-
age condition, any documentation that stability samples are
maintained at the designated temperature [21 CFR 211.166(a)
(2)]; and you do not have appropriate stability data to sup-
port the four year expiration date for the product. [21 CFR
                                                                        Controlling environmental conditions is more often about
                                                                        being notified of a problem than the actual failure itself.

                                                                  711                                            (continued on next page)
             Guide for US FDA-Regulated Organizations (continued)
There is no regulatory requirement to respond to a 483.                8. If the inspector noted something that you feel was an iso-
According to the agency, they are merely                               lated incident, document this fact and note it in your response.
“…inspectional observations, and do not represent a final              Be sure your data is complete and accurate. If you find some
agency determination regarding your compliance.” Sort of like          of the observations were in error after receiving the 483, there
an offer to help you with your compliance concerns. However,           is a formal dispute resolution process outlined in the agency’s
not responding quickly and carefully will most likely result in        “Guidance for Industry - Formal Dispute Resolution: Scientific
further investigation. In addition, all Warning Letters are posted     and Technical Issues Related to Pharmaceutical CGMP.5”
on the FDA’s site4 in html format and are therefore indexed by
search engines. Once you receive a 483, all anyone needs to            9. Be proactive. Reassess your internal compliance programs
do is type [Your Company/Lab’s Name] + FDA (or +483) into              — Why were 483 deficiencies not detected internally? Mention
the search box, and there you are.                                     this in your response letter, noting your commitment to QC/
                                                                       QA audit management. The definitive guide to what FDA
101/2 Tips for the Right Response                                      inspectors are looking for (at least in theory) is the agency’s
Your initial response must do three things: it must establish          “Investigations Operations Manual” accessible at:
credibility, it must demonstrate acknowledgement of the obser-         http://www.fda.gov/ICECI/Inspections/IOM/default.htm
vations and an understanding of the specific requirements
referenced, and it must show that your facility is committed to        10. If you need clarification, seek it—in writing and from the
corrective actions, any and all.                                       correct party. Ideally, when the investigator gave you the Form
                                                                       483 after the inspection you asked a lot of questions to clarify
You can show commitment by working cross-departmentally;               each observation. Try to be sure you are clear on each obser-
include a statement from all relevant department heads that            vation before the inspector leaves your facility and make notes
briefly but specifically addresses each observation. Each              while he/she is explaining the observations. If your questions
observation needs to have a corrective action—either planned           involve policy, contact the FDA headquarters—don’t contact
or accomplished—and it must be feasible and deliverable                your local FDA because policy is set at HQ.
within a predetermined time-frame.
                                                                       10.5 You may need an industry expert. There are many com-
Here are some tips—some simple, some in depth—for                      panies who specialize in creating and implementing regulatory
responding appropriately to 483 letters:                               strategy, whether from the ground up or from your existing
                                                                       quality and regulatory systems. If it’s worth doing, it may be
1. Get your response in on time and in writing. You have 15            worth hiring someone who knows how to do it really well. As
days, so ensure that final proofing and substantive editing is         regulatory compliance issues grow more complex, many com-
done at least by day 10.                                               panies have been created to provide solutions in common
                                                                       compliance areas like: response to agency queries and help
2. In the first paragraph of the response letter, be explicit in       with agency meetings, regulatory gap analysis and remedia-
your understanding of and desire to comply with FDA regula-            tion, internal GLP/GMP auditing and pre-approval inspections.
                                                                       Ways to Avoid 483s with Audit-Ready Environmental
3. Respond individually to each item that was addressed in             Monitoring
the Warning letter. Be specific. Do not try to solve all issues in     Ideally, your regulated environments and equipment are
one paragraph or your response may be rejected, prompting              always in full compliance with FDA regulations. An automated
further action from the FDA.                                           monitoring and alarming system providing high accuracy data
                                                                       at the point of measurement with back-up recording — can
4. Respond by importance – that is, respond individually to            make your QA/QC efficient, optimal and ready for any critical
items most likely to impact product quality.                           evaluation, internal or external. The continuous records that
                                                                       this type of system should provide could help be part of your
5. Be detailed yet concise in each response. Outline how each          detailed response to quality concerns outlined in a Form 483
deficiency will be corrected, and when, rather than how the            letter.
deficiency came to be. Provide documentation of a corrective
action commitment from the person responsible for it.                  For example, in the 483 excerpt of the CMO, which noted that
                                                                       “documentation that stability samples are maintained at the
6. Use positive statements; avoid language that implies fault.         designated temperature” A validated monitoring and alarm-
Address each item in the form 483 as an opportunity to fine-           ing system would provide secure, gap-free temperature data
tune the quality and compliance systems and personnel.                 recording. Data loggers with long-life batteries (up to 10 years)
                                                                       can continue to record temperature at the point of measure-
7. Include reference to how you will be forwarding evidence to         ment, rendering environmental data immune to network or
support the correction. For example, “<Company X> will use             power failures.
a validated monitoring and alarming system to provide reports
on temperature recordings taken at 10 minute intervals month-
by-month.” Product specifications and protocols of any new
systems can be provided or offered in support of the corrective
action plan.
                                                                     128                                         (continued on next page)
            Guide for US FDA-Regulated Organizations (continued)

                                                                 Every monitoring system should have a detailed IQ/OQ
                                                                 change control document make validation a straightfor-
                                                                 ward process.

                                                                 Some organizations compliant with GMP still use chart record-
                                                                 ers or manual methods to track temperature and humidity.
Monitoring, alarming and reporting are only as good as           The issues with these methods are beyond the scope of this
the measured data—accurate and continuous.                       article, but as more facilities automate processes within quality
                                                                 assurance and regulatory compliance, relying on older tech-
Regarding the blood bank 483 example, the storage units can      nologies is and will continue to be problematic. The FDA, with
be validated with the same equipment used to monitor. Self-      its strong recommendations, cannot insist that organizations
contained data loggers with internal sensors, memory and         upgrade to any given technology. But, a commitment to using
battery can be equipped for periodic testing or mapping the      industry-best instrumentation and systems in FDA-regulated
temperature distribution of the containers.                      research and manufacturing processes can stave off misgiv-
                                                                 ings about a facility’s commitment to quality.
In regard to the observations on the OTC Pharmaceutical
manufacturer, the challenge of not having adequately docu-       About the Author
mented temperature conditions would be solved by following       Ken Appel is Vice President of Regulated Markets at Veriteq
the detailed IQ/OQ and SOPs provided with the monitoring,        in Bellingham, WA. For more information:
alarming and reporting system.                                   www.veriteq.com/avoid-fda-483s

  Parts of this article were sourced, with permission, from two documents 1) “FDA 483 Responses—Compliance
Considerations” by Richard Poska and Ballard Graham, as published in the Journal of Validation Technology, Winter 2010
available with subscription at: http://www.gxpandjvt.com/ivtnews/templates/IVTNews.aspx?articleid=1896&zoneid=27
and the FDA Presentation 2) “Writing An Effective 483 Response” presented by Anita Richardson, Associate Director for
Policy, Office of Compliance & Biologics Quality at the 5th Annual FDA University RI Pharma Conference, January 2009 available
at: http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM102921.pdf
  “FDA’s Enforcement Crackdown To Increase Inspections, Delays”, Drug GMP Report - Issue No. 210, January 2010
  From the FDA’s Warning Letter web page: “Inspections, Compliance, Enforcement, and Criminal Investigations”
  See the ORA FOIA Electronic Reading Room at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Eight Students Participate in Student Poster Contest
           by Mike Fino of MiraCosta College

                     he San Diego Chapter of ISPE held its Second Annual Student Poster
                     Competition on June 3rd, 2010 at the UTC campus of Biogen Idec. The
                     Student Poster Competition is an annual event held regionally throughout the
               world where regional chapters pick the top graduate and undergraduate posters
               to send to the ISPE Annual Meeting. The Annual Meeting will be held in Orlando,
               Florida in November and the top regional picks showcase their work in the final
               International Student Poster Competition.

               Volunteer scientists and engineers from Biogen Idec judged the eight posters that
               participated in the 2010 San Diego competition. All the posters came from the
               Bioengineering Department at UCSD, where the student chapter is entering its sec-
               ond year of service. The Bioengineering Department has been a top ranked program
               nationally, typically placing in the top five. The quality of student and posters on dis-
               play were direct evidence of the esteem this department holds.

               In just the second year of managing the competition in San Diego, we had double
               the number of posters from our inaugural year. In all cases, the posters represent
               many months of hard work and diligence on behalf of the students. The eight posters
               entered into the competition include:

               1. Parameter Sensitivity Analysis in Cardiac Electrophysiological Models
                  Using NIMROD/E by Ramya Chitters

               2. ViewDock TDW: Rapid Visualization of Virtual Screening Results
                  by Christopher Lau

               3. In-silico identification of high potential SSH-2 specific inhibitors
                  by Matthew K. Mui

               4. Implementing Dock 6.2 Across a Grid Architecture:
                  Comparing Virtual Clusters to Opal OP Middleware by Wen-wai

               5. Optimization and Measurement of mCherry Maturation Time in Yeast
                  by David Lisuk

               6. An Amperometric Biosensor to Measure Physiological and Pathological
                  Lactate Levels by Justin R. Tse

               7. A High Throughout Workflow For The Analysis Of Diauxic Shifts In
                  Escherichia Coli In A Paired Carbon Substrate Environment
                  by Akshay Chaudhari
               8. Motion Based Sensing of Catalytic Nanomotors by Daniel Kagan

               The judges commented on the technical skill displayed in the posters but, most nota-
               bly, on the passion and enthusiasm they found in interviewing all of the students
               about their posters. In addition, it was a great opportunity for the students to explain
               their projects in an engaging and accessible manner since even the most technical-
               savvy engineer may have a hard time deciphering the work based on the titles!

               The judges ultimately chose the poster submitted by Justin Tse, entry number 6
               above. Justin will now enjoy an all-expense paid trip to Orlando, Florida to present
               his work in the International Competition. We want to recognize and congratulate all
               of the students that participated in the competition and we wish Justin the best of luck
               in Orlando. We know he’ll represent San Diego well!

               If your company is interested in hosting the 2011 Student Poster Competition or if you
               would like to work with the Student Affairs Committee, please contact the committee
               chair, Mike Fino (mfino@miracosta.edu).

                      Ultra Efficient Chilled Water Plants
             by Mike Barbera of Project Management Advisors, Inc.

      osted by Biogen-Idec, the San Diego Chapter was very proud to have such a strong turnout for the June meeting.
      Covering topics that included what an efficient chilled water plant is, what variable speed technology is, what resultant per-
      formance efficiencies can be achieved, and what the possible return on investment is, Ben Erpelding of Optimum Energy
presented materials for close to an hour before taking questions. At the conclusion of Ben’s question and answer session, Lee
Moran and Alex Ter-Vrugt of SDG&E presented on SDG&E’s incentive structure.

In an unexpected and direct conflict with game one of the Lakers versus Celtics, the strong turnout was a great mix of facilities
engineers and managers, engineering and other professional consultants, controls contractors, mechanical and electrical contrac-
tors, general contractors, and vendors.

 Mr. Erpelding’s presentation illustrated to the audience how central plant efficiency can be compared to the miles per gallon on
an automobile; how age and being near the ocean can have a dramatic affect on efficiency over time; and how an HVAC system
typically performs over time under standard, commissioned, recommissioned, and under variable-speed networked control. The
group was reminded of the importance of a designed load profile developed from the anticipated wet bulb temperature to serve as
the mechanical basis of design. Ben presented a number of case studies (laboratories included) showing the plant’s original con-
dition, the modifications made, the amount spent, energy saved, and cost savings and incentives that resulted in a high internal
rate of return.

Ultimately, Ben geared his presentation to show how a DDC based continuous commissioning system, which he equated to “a big
brother scenario,” would ultimately maximize system efficiencies through a networked solution, utilizing real time kilowatt measure-
ment and control by way variable speed components. Savings on a system-wide platform include a dramatic reduction in peak
kilowatt/hour performance, which results in system-wide savings in power, water, and gas.

Lee Moran and Alex Ter-Vrugt from SDG&E insightfully educated, and in some cases, re-educated the audience on their new
structure for assessment and approving incentive money. Importantly, the audience took away that SDG&E has implemented
their Savings by Design program, that they are available to assist in new design or existing operations overview, and that there
are options available for free third party assessments to determine at a high level what can be achieved for possible energy sav-
ings and incentives.

                                                 Membership Has its Benefits
                                                                 Enhance skills and share best practices.

                                      Knowledge                               Community                      Profession
                                   Increase your understanding            Meet like-minded professionals    Advance your career

                                                                    ISPE ... your Society of Choice.


                                                                                             A Foster Wheeler Company             Susanne Lage’ Cost
                                                                                                                                  Vice President,
                                                                                         • Process Development                  Business 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
                       ISPE San Diego Chapter Board of Directors
                                                                                             PHONE                EMAIL

President        Christy Pavano, West Reg Dir Bus Devel, CRB                                 760-496-7091         christy.pavano@crbusa.com
Vice President   Ashlee Ujifusa, Field Sales Representative, ProcessHQ                       760-730-9376         ashlee@processhq.com
Treasurer        Daniel Cooper, Inst/Controls Commissioning, CRB                             858-668-6247         dan.cooper@crbusa.com
Secretary        Mike Barbera, Sr. Project Manager, Project Management Advisors              858-704-1980         mikeb@pmainc.com
Director         Mujtaba Ali, Genentech                                                      858-458-8690         ali.mujtaba@yahoo.com
Director         Jonathan Bradley, Sr. Systems Engineer, Siemens Building Tech.              858-880-2043         jonathan.bradley@siemens.com
Director         Steven Chung, Control Systems Engineer, Dynalectric San Diego               (858) 712-4723 schung@dyna-sd.com
Director         Laura Ellery, Account Executive, Siemens Building Technologies              858-693-8711         laura.ellery@siemens.com
Director         Mike Fino, Professor, MiraCosta College                                     760-757-2121         mfino@miracosta.edu
Director         Rod Freeman, Mgr Facility Maintenance, Teva Parenteral Medicines            760-908-7305         wrfreeman@gmail.com
Director         Aaron Godwin, Automation /Controls Engineer, ATG Commissioning 858-568-0099                      agodwin@atgcommissioning.com
Director         Tim Price, Process Engineer, X-nth                                          858-597-0555         tprice@x-nth.com
Director         Stacy Sutton, Asst. Dir, Infrastructure/Logistics, Althea Technologies 858-882-0123              ssutton@altheatech.com
Director         Jerry Yaddgo, PE, Sr. Facilities Engineer, Biogen Idec, Inc.                858-401-8062         jerry.yaddgo@biogenidec.com
Past President   Don Holden, Sr. Electrical Designer, CRB                                    760-496-3714         don.holden@crbusa.com

                                                                                                                             High Purity Liquid Handling
                                                                                                                             Products for Pharmaceutical &
                                                                                                                             Biotech Industries


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                                                                                                     Technical Sales Representative
                                                                                                        (805) 906-1533 Cell

                                                                          321 Irving Dr., Oxnard, CA 93030                            www.sani-techwest.com

                                 New Member Lunch
                         by Ashlee Ujifusa of ProcessHQ, Inc.

                                                                            n Tuesday, May 4th we had our first new member lunch
                                                                            for 2010 at Rock Bottom Brewery in La Jolla. We had 21
                                                                            people attend the lunch and there was a good mixture of
                                                                     board members, new members and students.

                                                                     We passed out a brief survey for the new members and students
                                                                     to fill out and give us their feedback as to what they’re looking
                                                                     for from their new ISPE membership that I will actually use when
                                                                     the board of directors discuss ideas about upcoming events and
                                                                     educational courses. Everyone was able to introduce themselves
                                                                     and interact with each other and our board members and get a
                                                                     feel for what ISPE is about and all that ISPE offers its members.
                                                                     Everyone who spoke was very positive about joining and excited
                                                                     to be a part of such an active organization.

                                                                     Thanks to all who attended and for those of you who weren’t
                                                                     able to make this one, we will be having one more luncheon
                                                                     towards the end of the year. I look forward to seeing everyone at
                                                                     Vendor Night on August 12.

Swan and Dolphin Resort | Orlando, Florida, USA                                                        reality retooling growth

 Save the Date: 7-10 November 2010                                            Don’t Miss:
                                                                              Bruce G. Gellin, MD, MPH
   • 50+ Education Sessions totaling 150+ hours of                            Director of the National Vaccine Program Office (NVPO)
     classroom instruction                                                    Dr. Bruce Gellin is one of our Nation’s top experts on
                                                                              vaccines and infectious diseases.
   • Networking Opportunities all 4 days
   • Exhibits from over 250+ Suppliers from around the                        Experience the Business Behind the Magic
     world                                                                    In “Leading through Turbulent Times,” explore the proven
   • Young Professionals and Student Activities                               best practices that underlie the Disney approach to
                                                                              sustaining excellence during turbulent times.
   • COP Special Events
   • 2nd Annual Charity 5k Race                                               2010 Facility of the Year Awards
                                                                              The Overall Winner of the 2010 Facility of the Year Awards
                                                                              program will be announced at the Keynote Session – don’t
 Register Early And Save               Early Bird Pricing ends 11 October     miss this exciting announcement!

         www.ISPE.org/2010AnnualMeeting • Exhibit and Sponsorship Opportunities Available

                                                   ISPE Career Resources

         e understand that time and financial                   Below is a partial list of available articles:
         resources are limited. We know ISPE
         has to earn your continued Membership                  •   I’m Too Old to Change Jobs
by meeting your needs and helping you solve real-               •   Is Self-Employment a Good Option for Me?
world problems.                                                 •   Looking for That “Dream Job”? Utilizing Career Assessments
                                                                •   How Do I Re-enter the Workforce After a Long Absence?
For our Members facing a job transition, ISPE has               •   Successful Transition by Design
just launched “Career Solutions”, a resource-rich               •   Transferable Skills: Create a Winning Resume for a Brand New Industry
Web site portal featuring tools that you can use                •   Is Your Job Secure? How to Protect Yourself from a Slowdown in the
to help you locate a new position, and to help you                  Pharmaceutical and Biotech Industries
navigate during your job search.                                •   Three Ways You Can Protect Your Job in Times of Economic Insecurity
                                                                •   How Do I Make My Job in the Pharmaceutical Industry Recession-proof?
Career Solutions features free resume / CV                      •   Are You Employed? If So, You Need a Resume Now!
postings for job seekers and free job postings                  •   Letters of Recommendation
for employers, dozens of resources and links                    •   Make a Graceful Exit
designed to help maximize your job search, job                  •   Networking – A Lifetime Career Tactic
lists from around the world, and information on                 •   Ten Steps to Attain Your Competitive Edge
ISPE’s Hardship Program that enables you to                     •   Your Personal Brand: A Career Advancement Must-Have
keep your ISPE membership even when you are                     •   The 30-Second Commercial: What’s Unique About You?
out of work.                                                    •   Salary History/Requirements: To Tell or Not To Tell
                                                                •   Turning a Second Interview into a Job Offer
If you have not already done so, please visit www.              •   Interview Checklist: Strategies and Techniques to Help You Make a
ISPE.org/CareerSolutions and see what you’re                        Positive Impression
missing.                                                        •   Negotiating Salary: Avoid Common Land Mines
                                                                •   Some of the Most Commonly Asked Interview Questions - and Effective
This web resources lists jobs from ISPE and other                   Responses You’ll Want to Know
organizations around the globe. Access dozens                   •   Online Job Board Tips: Are You Applying but Getting Zero Responses?
of free videos, webinars, articles, and links to help           •   Keeping Spirits Up When the Job Search Gets Long
maximize your job search.                                       •   Nine Places to Look for the Future of Biotech

The library of articles can be a resource to those              Find more resources at: http://www.ispe.org/CareerSolutions
who are unemployed, those looking to transition,
and those who want to further their careers.

           Sensing & Inspection Technologies
           Leader in:
           Wired/Wireless Validation Systems:
           Kaye Validator®, Kaye ValProbe®, Kaye RF ValProbe®
           Stability Monitoring: LabWatch™, Kaye RF ValProbe®
           Calibration: References and Standards

    contact: Erik.Schmidt1@ge.com


                ISPE Launches Electronic Document Delivery System

  SPEhas announced the launch of its electronic document                         The next five documents slated for electronic download will
  delivery initiative with its first three technical documents.                  be GAMP® 5, Oral Solid Dosage Forms Baseline Guide,
  ISPE will release one to three technical documents per                         2nd Edition, GAMP® Good Practice Guide: A Risk-Based
month in this new format throughout 2010.                                        Approach to Operation of GxP Computerized Systems,
                                                                                 GAMP® Good Practice Guide: Manufacturing Execution
Sterile Manufacturing Facilities Baseline Guide, ISPE Good                       Systems (MES,) and GAMP® Good Practice Guide:
Practice Guide: Heating, Ventilation, and Air Conditioning                       Validation of Process Control Systems (VPCS).
(HVAC), and ISPE Good Practice Guide: Maintenance are
now available for sale as individual PDF downloads from the                      In addition to the upcoming release of the GAMP® Good
ISPE Web site. Professionals who are familiar with ISPE’s                        Practice Guide: Manufacturing Execution Systems (MES),
indispensable industry technical resources can now download                      registrants for the associated MES session at 2010 ISPE
these guides, cut and paste, search, print, and include TOC                      Washington Conference (7-10 June) will receive a free copy
bookmarks and links in the PDF file. Each document is cus-                       of the MES Guide.
tomized with individual watermarks, identifying the user who
downloaded the document.

                                                  Learn how to maximize the new
                                                    Risk-MaPP Baseline Guide®
                                            Available Q3 2010, this much-anticipated Guide provides a
                                            scientific risk-based approach based on ICH Q9 to manage the
                                            risk of cross-contamination in order to achieve and maintain an
                                            appropriate balance between product quality and operator safety.

                                                 Webinar • Conferences • Training

                                           Learn more at www.ISPE.org/Risk-MaPP

  VALIDATION                                       COMMISSIONING
                                                                                    Environmental Monitoring, Alarming, Reporting,
                                                                                       Stability &                             Automated
                                                                                       Clean Rooms        Keith Loftin         Reporting
                                                                                                        (480) 657-9911
                                                                                       Refrigerators,   kloftin@veriteq.com
                                                                                       Freezers                                  Flexible
                                                                                       & Coldrooms                               Alarming
  TRAINING                                                        AUDITS                                 www.veriteq.com

               500 Airport Blvd, Suite 100 • Burlingame, CA 94010                      Warehouses                                 Redundant
    Toll-Free (888) 242-0559 • Office (650) 320-1788 • Fax (650) 320-1789              & Archives                                 Recording

                     www.propharmagroup.com                                 15
                                    Welcome New Chapter Members
Nastaran Afari, Student, MiraCosta College                                  Mehnaz Malek, Student, California State Polytechnic University
Janes Andrade, Supply Chain Manager, Althea Technologies Inc                Judy McMackin, President, CLEAR Solutions, Inc.
Ben Beus, Consultant, Beus Consulting, Inc.                                 Joseph Mendiola, Sr Superior-Process, Althea Technologies Inc
Marcy Beyer, Student, MiraCosta College                                     Juan Mendoza, Compliance/Training Specialist, Anchen Pharmaceuticals
Brian Blasquez, Director QA Validation, Amylin Pharmaceuticals              Gregory Miazgowicz, Student, MiraCosta College
Kreigan Brink, Construction Logic, Inc.                                     Gregory Mills, Director, AxR Tech Lighthouse
Geoffrey Brown, Validation Specialist, Commissioning Agents, Inc.           Matthew Mui, Student, University of California, San Diego
Alvin Cabrera, Student, University of California-San Diego                  Tallie Noble, Student, MiraCosta College
Robert Camilo, Project Manager, Abbott Vascular Quality IT                  John Olsson, President, Q Builders Inc
Jamison Campbell, Validation Consultant, Hyde Engineering/Consulting        Irmingarda Padgett, Student, East Carolina University
Kimberly Chan, Student, University of California-Berkeley                   Michael Passaglia, Student, San Jose State University
Lilyana Chandra, Student, University of California-Berkeley                 Melody Pobuda, Post Undergrad Ed., MiraCosta College
Akshay Chaudhari, Student, University of California San Diego               Jean Purvis, IT Project Manager, Abbott Vascular
Wayne Clark, CEO, Novatron, Inc.                                            Charles Rampersaud, VP, Engineering, AcelRx Pharmaceuticals, Inc
Jurentina De Giso, Student, MiraCosta College                               Samantha Rhodes, Student, MiraCosta College
Liem Duong, Student, MiraCosta College                                      Ryan Rico, Student, MiraCosta College
Adriana Espindola, Caregiver, MiraCosta College                             Tim Schulze, Principal, Pacific Cornerstone Architects Inc
Geoffrey Fortuna, Supervisor, Site Planning, Biogen Idec                    Heather Schutten, Admin, SmartPractice
Jason Gabunilas, Student, University of California-San Diego                John Scott, Application Specialist, Process Integration
Ivanka Gavanski, Sr Analyst Product Quality, Amylin Pharmaceuticals         Jigar Shah, Director of Marketing, GoIndustry DoveBid
Vaidy Gopalan, Staff Validation Engineer, Abbott Vascular                   Scott Sigurdson, General Manager, J&M Keystone, Inc.
Christopher Gregory, Business Analyst, Compliance, Prometheus Labs          Dmytro Sokolovskyy, Student, University of California-San Diego
Michael Hoene, Senior Market Manager, Kimberly Clark                        Kaveh Soofer, VP Sales and Engineering, Plastikon Industries
Seyedeh Mahboobeh Hosseini, Student, UC Davis                               David Sozzani, Student, MiraCosta College
Eugene Hsu, Engineer, MiraCosta College                                     Roger Sparling, Aftermarket Sales, R.F. Macdonald Co
Tadeus Imrich, Sales Rep, IPT Group, LLC                                    Rachel Stuart, Validation Scientist, Commissioning Agents, Inc.
Kate Jacobsen, University of California, San Diego                          Bryan Taggart, Student, MiraCosta College
Suryaprakash Jayaramu, Senior Analyst, Abbott Vascular                      Luigi Tanaquin, Student, MiraCosta College
April Jocson, Process Dev Supervisor, Althea Technologies, Inc.             Reza Tavana, Validation Engineer, Commissioning Agents Inc.
Daniel Kagan, Graduate Student Bioengineering, UC San Diego                 Viet Tran, Recruiter, Proven, Inc.
Amir Katz, University of California-Berkeley                                Justin Tse, University of California, San Diego
Elan Katz, Student, University of California-Berkeley                       Marcos Valencia, University of California-San Diego
Zahra Khedri, Student, University of California-Davis                       Larry Vander, Schaaf, Associate Dir, Instrumentation, Gen-Probe
Keely Landon, Microbiologist, Althea Technologies, Inc.                     Alejandra Varela, Outside Sales Engineer, George T. Hall
Christopher Lau, Student, University of California-San Diego                Xiaodian Wang, Student, University of California-Berkeley
James Lin, Student, University of California-Berkeley                       Alex Yee, University of California-San Diego
Olivia Lin, University of California-San Diego                              Wen-wai Yim, Student, University of California-San Diego
Diana Lok, Student, University of California-San Diego                      Keith Zucca, Site Head of Quality, Novartis
Mark Lovallo, Sales Engineer, Pump Systems, Inc.
Yasmin Lucky, Student, MiraCosta College

                  Tour of Beckman Center for Conservation Research
                     by Dan Cooper of CRB Consulting Engineers
                     Photos by Pam Wammes of Water Works Inc.

                                                              he ISPE San Diego Chapter presented a tour of the Arnold and Mabel Beckman
                                                              Center for Conservation Research on April 29th at the Wild Animal Park. The
                                                              event was a sell-out although somewhat different than the typical ISPE facilities
                                                       tour. Some of the highlights included; the one of a kind frozen zoo which contains more
                                                       than 8,000 living tissue sample of various species; the reproductive physiology division
                                                       that assists in the reproduction of endangered species which included the yellow legged
                                                       frog which was once plentiful in the San Jacinto Mountain area, but was almost brought
                                                       to extinction by the bullfrog. The frogs are being introduced back into the wild after
                                                       successful breeding at these facilities. The trip also included a tour of their vast library
                                                       which is used by researchers of all disciplines.

                                                       The tour was preceded by a great dinner which included presentation of some of the
                                                       Wild Animal Parks animal ambassadors.

                                                       The event was sponsored by Siemens Building Technologies, CRB Engineers/Builders,
                                                       Waterworks, Pacific Rim Mechanical, and Ferguson Pape and Baldwin Architects..
                                                       Thanks to all who attended and/or sponsored this event. A special thank you goes to
                                                       Maggie Reinboldt and the Wild Animal Park for hosting this event.

                                                   High Purity Liquid Handling
                                                   Products for Pharmaceutical &
                                                   Biotech Industries


                               Chris Ballew
                           Technical Sales Representative
                              (805) 906-1533 Cell

321 Irving Dr., Oxnard, CA 93030                            www.sani-techwest.com
                                                    ISPE Event Calendar
                                                    Theme for 2010 ISPE San Diego Chapter
                                                            Investing in the Future:
                                                      Staying in the Black by Going Green

       ISPE SAN DIEGO                  12 August            Vendor Night Exhibit Show
          CHAPTER                                           Free Seminar on Novartis Solar Project
                                                            at Hilton La Jolla Torrey Pines
     5319 University Dr., Suite 641
                                       13 August            Golf Tournament
           Irvine, CA 92612
                                                            at Arrowood Golf Course in Oceanside

         Chapter Hot Line:             30 September         Annual Facilities Reception
         (800) 869-9621 or                                  Joint event with BIOCOM and IFMA
           (949) 387-9046              15 October           Full Day Meeting
                                                            at Mira Costa College
         (949) 387-9047 or             7-11 November        ISPE Annual Meeting - Swan and Dolphin Resort
           (949) 266-8461                                   Lake Buena Vista, FL

     For advertising information:      18 November          Facilities Summit

     www.ispe.org/SanDiego                   All events subject to change due to availability of venue/speakers.
   ISPE is a global, not-for-profit
   membership organization that                             To Register for Any ISPE SD Meetings:
  provides education, training, and                 http://event-confirmation.com/ispesd_meetings.htm
      technical publications to
   pharmaceutical manufacturing                            Chapter Web site: www.ispe.org/sandiego
                                                                ISPE’s Global Calendar
      Join ISPE Today For Great               and Additional ISPE Educational Offerings and Publications:
        Membership Benefits:                                        www.ispe.org
• Member Only Events/Facility Tours
• Discounts to Educational Programs
and Technical Documents
• Subscription to Pharmaceutical
Engineering magazine, with access to
on-line article archives
                                                              Free Career Development
• Connection to more than 25,000
Members from 90 countries through                                  Webinar Series
an on-line Membership Directory
                                                                       For Members Only!
               and More!

            PHOTO CREDITS                           Join us for three ISPE exclusive live Webinars
      Cover Photo from fotolia.com:                 aimed at helping you manage your career options
      by photographer Armin Sepp                    and strengthen your marketability.
            Other Photos                            Register at www.ISPE.org/CareerEvents
       Christy Pavano, CRB
  Kimberly Syre, Attention To Detail       Presented By:
     Ashlee Ujifusa, Process HQ


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