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Published by the ISPE San Diego Chapter Serving Southern California from San Diego to Orange County
Editor: Kimberly Syre Email: [email protected]: Phone 1.949.387.9046 and Fax 1.949.266.8461
IN THIS ISSUE
Our ISPE San Diego Chapter is wrapping up a summer full of revitalized programs fol-lowing our 2011 theme Live, Learn and Lead.
Live - This year we revamped our Annual Vendor Night by getting more owner/end user companies involved in the planning and attendance. The results were a noticeable increase in owner company attendees, increased exhibit tables, increased overall attendance and a tremendous amount of positive feedback. It was a fun evening filled with live entertainment, raffle prizes and a trip to Vegas was won by Victor Khachatourians of PaxVax.
Our Annual Summer Golf Tournament was held the following day at Encinitas Ranch. This was a new, more centrally located course for our tournament that was well received by all of the participants.
NEWSLETTER • Volume 17, No. 4 • www.ispe.org/sandiego
President’s MessagePAGES 1-2
15 September Full Day
Project Management ClassPAGES 3-5
2011 ISPE Annual MeetingPAGE 6
Overview of Process Safety MeetingPAGE 7
ISPE Partners with U.S. EPAOn ENERGY STAR Program
PAGE 8
Welcome New MembersPAGE 9
Photos from Clinical Trials and Student Poster Contest Meeting
PAGE 10
ISPE Releases 2nd Edition GAMP® Guide on GxP Process
Control SystemsPAGE 11
14 October Deadline for Facility of the Year Award Entries
PAGE 12
Photos from Bring Your Kid to ISPE Night
PAGE 13
Your Board of DirectorsPAGE 14
2011 ISPE Event CalendarPAGE 15
(continued on next page)
President’s Message by Christy Pavano of CRB
ISPE’s Award Winner for Excellence and Innovation 2007-2010
The Chapter’s Student Poster Contest included 10 posters from ISPE Student Members at UCSD. Poster Contest Participants and Judges in photo above.
President’s Message (continued)
2
Engineering
Architecture
Process Technology
Process Automation
Systems Integration
Construction Management
Startup & Commissioning
Procurement
Project Management
Nino Borsoni, PMP - Senior Vice President
p. 925.363.3112
f. 925.689.7006
San Diego/OCSTERIS Corporation
David Spencer-Capital [email protected](949) 228-0269
Stacey [email protected](949) 436-1513
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6'!.99/BC!!777D%#$%&#'$E'F)D3'G!!!
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Dendreon is Hiring – Los Angeles Region ! Facilities and Engineering Talent with specific cGMP
experience ! Facilities Maintenance Technicians ! Facilities Maintenance Supervisors ! Facilities Engineer
To Apply: www.dendreonjobs.com !!
Learn – We had three new technical programs; Process Safety, Clinical Trials combined with our USCD Student Poster Competition and 483 Observations by former FDA Investigator Jeff Yuen.
Lead – In an attempt to lead kids towards a career in science we held a unique facility tour of an endangered species lab. This was our first “Bring your kid to ISPE” event.
On September 15th, we will be having a full day class on Project Management being held at Genentech. Look for details on that and the other programs in this newsletter.
I look forward to seeing you at our next event!
Christy
Meeting and Facility Tour Locations NeededIn an attempt to keep meeting prices down for our Members, the Chapter is looking for new companies to host our meetings. If you have a facility that can host a tour or a meeting for 5o+ attendees for evening and/or full day classes, we would like to discuss options with you. A benefit of hosting an event is free training for your employees.
Please contact our Chapter Manager Kimberly Syre to discuss details:Tel: 949-387-9046 • Email: [email protected]
Full Day ExtEnDED EDucation class
Thursday, sepTember 15, 2011 Project Management Class
LOCATION: Genentech1 Antibody Way, Oceanside, CA 92056
This Project Management Class will help participants learn some of the basic tools in implemen-tation of a successful project. Proven industry experts will do a walk-thru of the basic steps in the following categories:
• Setting up a project Charter
• Selection and Management of Subcontractors
• Building a solid team
• Quality Management
• Risk Management and mitigation
• Management of Scope and Change Control
• Project Execution
After attending this course, you should have a basic understanding of the critical components of executing a successful project and how not managing these things well can cause increased time and cost to project delivery.
Sponsors:Endress + Hauser Inc.
Project Management Advisors, Inc.3
Full Day ExtEnDED EDucation class
Thursday, sepTember 15, 2011
Project Management ClassLOCATION: Genentech
1 Antibody Way, Oceanside, CA 92056
Program Managers: Steven Chung, Control Systems Engineer, Dynalectric Dan Cooper, Instrumentation and Controls/Commissioning, CRB
Schedule of Presentations7:30 - 8:30 am Registration and Breakfast
8:30 - 9:30 am Project CharterPresented by Frank Jones, Project Executive, DPR Construction
9:30 - 10:30 am Subcontractor Management and Selection ProcessPresented by Carlos Crabtree, Project Executive, DPR Construction
10:30 -10:45 am Break
10:45 - 11:45 am Team Building and CollaborationPresented by Laura Cribbons, Director of Program Management, ProPharma Group, Inc.
11:45 - 12:45 pm Lunch
12:45 - 1:45 pm Quality Management/Organization Change ManagementPresenter TBD 1:45 - 2:45 pm Risk Management Presented by Frank Jones, Project Executive, DPR Construction
2:45 - 3:00 pm Break
3:00 - 4:00 pm Management of Scope and Change ControlPresented by Patrick A. Deming, Quality Assurance & Change Control, Genentech
4:00 - 5:00 pm Project ExecutionPresenter TBD
Additional Sponsorships Available, See Registration Form for DetailsTo Join ISPE: www.ispe.org
4
Sponsors:Endress + Hauser Inc.
Project Management Advisors, Inc.
Full Day ExtEnDED EDucation class Thursday, sepTember 15, 2011
7:30 am - 5:00 pm
REGISTRATION PROJECT MANAGEMENT CLASS - September 15, 2011To Register and Receive an immediate receipt, use our on-line registration:
http://www.atdevents.net/ispesandiego.phpIf you have an account on our system, please log on and register. If you do not have an account, you can set one up on the site using letters (not numbers) as your username. If are an ISPE Member in California, you may already be in our system. Your ISPE Member number is your username. The website will email you your password or username if you do not know them.
Registrations can also be faxed using this form with credit card payment. Fax to 949-266-8461 or 949-387-9047. Mail your check made payable to: ISPE SAN DIEGO CHAPTER, 5319 University Dr., Suite 641, Irvine, CA 92612. Chapter Hotline (800) 869-9621 or (949) 387-9046. Name Badges will be given at the event. ISPE San Diego Chapter Tax ID#33-0551783. Contact Kimberly Syre: [email protected] with any questions.
Cancellations must be received in writing by September 8, 2011 for refund. After the cancellation date if you have reserved a space but do not attend, your payment MUST be remitted, however, an alternate person may attend in your place. If the alternate is not a member, they will need to join
Name Badges will be given at the on-site registration desk.
Continental Breakfast and Lunch Provided
COST ❑ Free For Genentech employees (please Fax this Form or email: [email protected] to Be added to the list)
❑ $195 ispe memBers ❑ $100 ispe student memBers/Government
❑ $275 non-memBers
❑ $500 meetinG sponsor
First Name:
Last Name:
Title:
Company:
Address:
City:
State: Zip:
Tel Number:
Fax Number:
E-Mail:
CREDIT CARD PAYMENT
Type of Credit CardCircle One
Name on Card:
Credit Card #:
Exp Date:
Signature:
ISPE Member:
Chapter Affiliation:
Project Management ClassLOCATION: Genentech, 1 Antibody Way, Oceanside, CA 92056
Program Managers: Steven Chung, Control Systems Engineer, Dynalectric Dan Cooper, Instrumentation and Controls/Commissioning, CRB
Sponsors:Endress + Hauser Inc.
Project Management Advisors, Inc.
Industry Experts and Regulators Present
6-9 November
GayloRd TExaN dallas/FT. WoRTh (GRaPEvINE)
TExas | Usa
Join us at Annual Meeting to connect and engage with industry leaders and contribute to the advancement of your industry.• 30+ education sessions and three training courses • More than 250 exhibitors from around the world• Networking Opportunities including: Activities for Young Professionals and Students Community of Practice (COP) Special Events 3rd Annual Charity 5K Race
2011 Annual Meeting Sponsorship and Exhibit Opportunities are Available!
For details contact Daniel Murphy at [email protected] or John Phillips at [email protected].
Register Early and save! Early Bird Pricing Ends 10 Octoberwww.ISPE.org/2011AnnualMeeting
2011 ISPE Annual Meeting:Preparing Professionals and organizations for Rapid Change
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Overview of Process Safety MeetingPhotos by Kimberly Syre, Chapter Manager
On March 24th we had an event at Amylin Pharmaceuticals with presentations on Process Safety Systems. The presenta-tions addressed a variety of safety issues pertaining to process systems and methods to avoid catastrophes from happen-ing. The presentations included:
Safety System Standards and Best Practices by Joe Hohn, Control Systems Engineer, Dynalectric Joe discussed the best policy for assurance of safety is also the best policy for economic considerations. The risk associated with lack of attention to process hazards is a major threat to both life and plant availability. The presentation was a fast-paced course that used the approach specified in ANSI 84.01 and IEC61511, ‘Application of Safety Instrumented Systems for the Process Indus-tries’ to provide a framework for evaluating and quantifying process risk and to designing and implementing systems that mitigate that risk and prevent propagation of the hazard.
Design Concerns when using Flammable Liquids by JT Cochran, Process Engineer, CRB
Jobsite Safety during Construction by Randy Gompper, Safety Coordinator, DPR Construction
Thank you to our speakers, to Amylin Pharmaceuticals for hosting the meeting, and to BN Builders, CRB, DPR Construction and Project Management Advisors for sponsoring the event.
WWW.COMMISSIONINGAGENTS.COM
Local Contact: David ShenbergerCell: [email protected]
VALIDATION
COMMISSIONING
QUALITY & COMPLIANCE
PROCESS IMPROVEMENT
SPECIALIZING IN SOLUTIONSLOCALLY AND WORLDWIDE
7
ISPE Announces Partnership with U.S. Environmental Protection Agency’s ENERGY STAR Program
--Sustainable Facilities Community of Practice to spearhead involvement--
ISPE has partnered with the U.S. Environmental Protection Agency (EPA) on its successful ENERGY STAR Program. Through
participation in the program, ISPE aims to improve pharmaceutical industry exposure to the program and help ISPE Members
drive cost savings and green initiatives for their companies.
“Sustainability and environmental stewardship have long been a part of the ISPE culture and goals,” said Bob Best, ISPE President
and CEO. “And helping our Members to deliver cost effective GMP
solutions has always been an integral part of ISPE’s mission. There-
fore, the ENERGY STAR Program is a perfect fit for us. By helping to
disseminate the ideas behind the program, we hope that our Members
around the globe will be more successful in improving energy efficiency
throughout the industry.”
The ENERGY STAR Challenge for Industry calls upon businesses
to create a five-year plan to reduce energy intensity by 10% or more.
Companies that publicly join the Challenge and meet the goal are
recognized by the U.S. EPA for their efforts, and gain the right to capi-
talize on one of the most recognizable names in energy efficiency by
communicating publicly that they have completed the ENERGY STAR
Challenge.
The driving force within ISPE for ENERGY STAR information and
participation will be the Sustainable Facilities Community of Practice
(COP). Interested parties may join the Sustainable Facilities COP to
gain information, engage in conversation, share best practices, and
report progress on the Challenge. More information on the Sustainable
Facilities COP can be found at www.ispe.org/sustainablefacilities. More
information on the ENERGY STAR Challenge can be found at www.
energystar.gov/index.cfm?c=industry_challenge.industry_challenge.
Please send all mail correspondence to :
600 N. Westshore Blvd. • Suite 900Tampa, Florida 33609 • USA
You can still reach us via telephone at: +1-813-960-2105 and
via fax at: +1-813-264-2816
www.ISPE.org
ISPE Headquarters Has Moved!
Connecting a World of Pharmaceutical Knowledge
www.ISPE.org
Please send all mail correspondence to :
600 N. Westshore Blvd. • Suite 900Tampa, Florida 33609 • USA
You can still reach us via telephone at: +1-813-960-2105 and
via fax at: +1-813-264-2816
www.ISPE.org
ISPE Headquarters Has Moved!
Connecting a World of Pharmaceutical Knowledge
www.ISPE.org
Please send all mail correspondence to :
600 N. Westshore Blvd. • Suite 900Tampa, Florida 33609 • USA
You can still reach us via telephone at: +1-813-960-2105 and
via fax at: +1-813-264-2816
www.ISPE.org
ISPE Headquarters Has Moved!
Connecting a World of Pharmaceutical Knowledge
www.ISPE.org
Have an idea for a meeting topic in 2012?
Please contact our Program Chair
Steven Chung
Tel: 858-712-4723
Email: [email protected] 8
Welcome New Chapter MembersMarch - July 2011
Kevin Balliger, Sales Rep, Mettler ToledoAvril Bland, Consultant, PSC Biotech
Samuel Boykin, Student, Solano Community CollegeErnesto Canello, Facility & Engineering Manager, AllerganBryce Caputo, Student, University of California-Berkeley
Brian Chancler, Siemens IndustrySean Conroy, Student, University of California-San Diego
Steve Dorland, Director, QA, Sangart Inc.Joe Fabian, Field Sales Engineer, George T. Hall Company
Barbara Galangue, Adjunct Faculty, Gateway CollegeYukti Gangwani, Student, University of California-San Diego
Danielle Goodlett, Associate Director, Ardea Biosciences, Inc.Gregory Heiland, Executive Director, GSFCC
Banu Inceoglu, Sr Validation Scientist, Bayer HealthCareScott Karney-Grobe, University of California-San Diego
April Kim, University of California-San DiegoMargaret Kuleshova, University of California-San Diego
Tonya LemmonJieying Li, Student, University of California-San Diego
Juan Pacio, Engineer, CRB Consulting EngineersBryan Phillips, Sr Manager, QA Validation, Herbalife, Inc
Bryan PospisilAlan Priester, Student, University of California-San Diego
Andrew Richards, Student, University of California-San DiegoJames Roensch
Carl Sandvik, Director, Business Systems, Beckman CoulterTim Schultz, Stonhard
Jim Shatting, North American Sales Manager Contamination Control, TSI Inc.Vishnu Sridhar, Student, University of California-San DiegoChia-Hung Tai, Student, University of California-BerkeleyZhala Tawfiq, Student, University of California-San Diego
Barbara Thomsen, Construction Engineer, CRB Consulting Engineers, Inc.Francis Tse, University of California-San Diego
Deepthi Vijayraghavan, Student, University of California-San DiegoTravis Wagner, Mechanical Engineer, CRB
Qianqiong Wang, Student, University of California-San DiegoChris Watts, Partner, NNE Pharmaplan
Carson Whiting, Director QA, PrimPharm Inc.
9
Photos of the Student Poster Contest and Clinical Trials Meeting in AprilHosted by Amylin Pharmaceuticals
By Christy Pavano, CRB
10
(L-R): Student Poster contest winner Scott Revelli and ISPE’s UCSD Student Chapter Faculty Advisor, Dr. Melissa Micou.
(L-R): Trinh Le receives speaker certificate from Chapter President, Christy Pavano.
Thank you to our sponsor MEIRxRS CRO, Recruiting and Staffing.
UCSD Student Chapter Vice PresidentKenneth Ng.
In April we had event at Amylin Phar-maceuticals on Clinical Trials. Our speaker was Trinh Le from Intellikine
and she gave us a presentation on why some products make it to market while others do not and exactly what is going on behind the scenes. Her presentation was very informative and relevant to some of the pains felt by local San Diego Biotech and Pharmaceutical companies. Thank you to our sponsor MEIRxRS CRO, Re-cruiting and Staffing.
Prior to the clinical trials presentation we had our Annual Student Poster Competi-tion that included 10 finalists from UCSD. The judges were Ryan Shore from Amylin, Maulik Trivedi from Amylin, Kelly Cooper from Genentech, and Christy Pavano from CRB. All of the posters were great and reflected the amount of effort that each team put into them.
The Third Place winner was Deepthi Vijayraghava, Second Place went to Jes-sica Yang and First Place went to Scott Revelli. Scott won a trip to the ISPE Annual Meeting in Dallas, TX where he will present his poster titled Design Of An Injection Catheter For Delivering Biomate-rials To The Heart for a chance at winning the national student poster contest.
Thank you to all of the other students who participated; Andrew Richards, Kelli Xu, Sean Conroy, Alan Priester, Kenneth Ng, Wen-Wai Yim, and Neil Gahdi.
Scott Revelli is the current President and Kenneth Ng is the Vice President of our ISPE UCSD Student Chapter and have done a phenomenal job of growing our Student Members and interest in ISPE.
We look forward to working with our new ISPE UCSD Chapter President Yutki Gangwani and Vice President Kate Ja-cobsen.
To learn more about the ISPE UCSD Student Chapter, please visit the website at
http://ispe.ucsd.edu/
ISPE Releases GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems, Second Edition
--Guide updated to align with recent regulatory and industry developments--
ISPE has recently released GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition.) The Guide, which provides guidance on how to achieve process control systems that are fit for intended use and meet current regulatory requirements, has been significantly updated to align with the concepts and terminology of recent regulatory
and industry developments.
Developed by the GxP Process Control Systems Document Revision Task Team, and members of the ISPE GAMP Community of Practice (COP) Process Control Special Interest Group (SIG), the Guide recognizes that Good Engineering Practice meets most of the applicable compliance requirements. The Guide also emphasizes that in order to be efficient, appropriate specification and veri-fication activities should be an integral part of the normal system life cycle. The Guide recognizes that many suppliers of systems now have mature quality management systems and system development, test, and support documentation. The Guide promotes the leveraging of supplier documentation and activities to avoid unnecessary duplication, cost, and waste.
Concepts addressed by the new Guide include the International Conference on Harmonisation (ICH) Guidance setting out expecta-tions for the application of science- and risk-based approaches to drug development and manufacture supported by pharmaceuti-cal quality systems and ISPE’s Product Quality Lifecycle Implementation® (PQLI®) global initiative for a practical approach to implementation of ICH guidances Q8 (R2), Pharmaceutical Development, Q9, Quality Risk Management, and Q10, Pharmaceuti-cal Quality System. FDA cGMPs for the 21st Century Initiative and other emerging industry standards also were influences as the Guide was developed.
The GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems will be available for purchase in book form and is already available as a downloadable PDF. The cost of the document is US$145/€115 for ISPE Members and US$405/€345 for non-members. More information can be found at www.ISPE.org/GuideanceDocs/GAMP-GxP-Process-Control-Systems.
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• Process Development & Scale-Up • Critical Utility Design • cGMP Upgrades • cGMP Facility Design • Debottlenecking • Custom Process Equipment • Commissioning/Qualification/Validation
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GESensing & Inspection TechnologiesLeader in: Wired/Wireless Validation Systems:Kaye Validator®, Kaye ValProbe®, Kaye RF ValProbe®Stability Monitoring: LabWatch™, Kaye RF ValProbe®
Calibration: References and Standards SALESCALIBRATIONSERVICERENTALS
www.gesensing.com/kayeproductscontact: [email protected]
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Chelants for derouging and passivation for the Pharmaceutical Industries.
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§ Services include new system passivation, derouging / passivation
maintenance, system inspection, biofilm removal, and sanitization.
Facility of the Year Awards2012 Call for Entries
The Facility of the Year Awards program is an annual program that recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to both improve the quality of the project and to reduce the costs of producing high-quality medicines. The Awards program provides a platform for the pharmaceutical manufacturing industry to showcase its new products and accomplishments in facility design, construction, and operation.
Projects from around the world have already been named Category Award Winners in the annual Facility of the Year Awards program, and we would like to receive a submission from you. The Facility of the Year Awards program, co-sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, recognizes projects that demonstrate global leadership by showcasing cutting-edge engineering, innovative new technology, or advanced applications of existing technology.
Don’t let your company pass up this outstanding opportunity to showcase its new or renovated facility!
For additional information about the Awards program and submission procedures, visit www.FacilityOfTheYear.org. You may also contact Scott Ludlum, ISPE Director of Business Initiatives, by tel: +1-813-739-2284 or by email: [email protected].
Connecting a World of Pharmaceutical Knowledgewww.FacilityOfTheYear.org
2012
Deadline For Submissions:14 October 2011
In an effort to get kids interested in science we had our first Bring Your Kid to ISPE event held at the Beckman Center for Conser-vation Research facility at the San Diego Safari Park (formerly Wild Animal Park). The event started with live animal demonstra-tions and dinner in the beautiful courtyard. Then we were led on an informative and interactive tour of the facility which houses
six laboratories and six research divisions and is a Silver-level LEED certified facility.
The facility is dedicated to making ground-breaking innovations in science and technology that helps solve complex conservation problems. The facility houses a Genetics Division which is home to the one-of-a-kind Frozen Zoo. The Reproductive Physiology Di-vision uses innovative technologies to assist in the reproduction of endangered species, including giant pandas, kiwis, and several aquatic species.
The kids really enjoyed all of the animals and had some fun during the tour where they did a pretty good job answering questions posed by our guide. Some of kids even identified lab equipment that their parents work with. I think we had some future scientists in the crowd.
Bring Your Kid to ISPE Nightby Christy Pavano, CRB
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Oscar Garcia Technical Sales Representative (323) 252-1110 Cell [email protected]
Sandra Medlin Technical Sales Representative (510) 290-1232 Cell [email protected]
Bob Miller Technical Sales Representative (510) 967-9397 Cell [email protected]
www.sani-techwest.com www.sanisure.com
High Purity Liquid Handling Products Engineered Single Use Solutions
ISPE San Diego Chapter Board of Directors PHONE EMAIL
President Christy Pavano, Director Business Development, West Region, CRB 760-496-7091 [email protected]
Vice President Daniel Cooper, Instrumentation & Controls/Commissioning, CRB 858-668-6247 [email protected]
Treasurer Mike Barbera, Sr. Project Manager, Project Management Advisors 858-704-1980 [email protected]
Secretary Stacy Sutton, Director of Engineering, Althea Technologies 858-882-0123 [email protected]
Director Jonathan Bradley, Sr. Systems Engineer, Siemens Industry 858-880-2043 [email protected]
Director Steven Chung, Control Systems Engineer, Dynalectric San Diego 858-712-4723 [email protected]
Director Laura Ellery, Climatec 858-212-8411 [email protected]
Director Mike Fino, Professor, MiraCosta College 760-757-2121 [email protected]
Director Rod Freeman, Validation Manager, Beckman Coulter 760-908-7305 [email protected]
Director Aaron Godwin, Automation /Controls Engineer, ATG Commissioning 858-568-0099 [email protected]
Director Nicole Hall, Business Liaison, Pacific Region, Commissioning Agents 215-237-5127 [email protected]
Director Dave Stewart, Automation, Genentech 760-231-2473 [email protected]
Director Ashlee Ujifusa, Field Sales Representative, ProcessHQ 760-730-9376 [email protected]
Past President Don Holden, Sr. Electrical Designer, CRB 760-496-3714 [email protected]
Still Fail-safe. Now, even better.Veriteq is now a Vaisala Company.Learn about our expanded monitoring,alarming & validation/mapping systems.
ISPE SAN DIEGOCHAPTER
5319 University Dr., Suite 641 Irvine, CA 92612
Chapter Hot Line:(800) 869-9621 or
(949) 387-9046--------------------
Fax:(949) 387-9047 or
(949) 266-8461
For advertising information:www.ispe.org/SanDiego
_______________________ISPE is a Society of pharmaceutical
professionals who use expert knowledge to create high-quality,
cost-effective GMP solutions.
Join ISPE Today For Great Membership Benefits:
• Member Only Events/Facility Tours• Discounts to Educational Programs and Technical Documents• Subscription to Pharmaceutical Engineering magazine, with access to on-line article archives• Connection to more than 24,000 Members from 90 countries through an on-line Membership Directory
and More!
Cover Photo from fotolia.com: by photographer Janet Wall
ISPE Event Calendar Theme for 2011 ISPE San Diego Chapter
Live, Learn and Lead
15 September Full Day Project Management Class at Genentech in Oceanside Tools for Implementation of a Successful Project • Setting up a project Charter • Selection and Management of Subcontractors • Building a solid team • Quality Management • Risk Management and mitigation • Management of Scope and Change Control • Project Execution 20 October Full Day HVAC Class
6-9 November 2011 ISPE Annual Meeting: Preparing Professionals and Organizations for Rapid Change Industry Experts and Regulators Present Global GMP Solutions for Manufacturing, Technology, Regulations, Facilities and Investigational Products Featuring 30+ Education Sessions and Three Training Courses More than 250 Exhibitors from Around the World Networking Opportunities Including: • Activities for Young Professionals & Students • Community of Practice (COP) Special Events • 3rd Annual Charity 5K Race Location: Gaylord Texan in Dallas/Ft. Worth (Grapevine) Texas Register by October 10 for Early Bird Discount
17 November Temecula Winery Tour Social Event
All events subject to change due to availability of venue/speakers.
To Register for Any ISPE SD Meetings:http://www.atdevents.net/ispesandiego.php
Chapter Website: www.ispe.org/sandiego
ISPE’s Global Calendar and Additional ISPE Educational Offerings and Publications:
www.ispe.org
15