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NEWSLETTERVolume 15, No. 3
Published by the ISPE Greater Los Angeles Chapter Serving Southern California’s
Los Angeles, Orange, Ventura and Riverside CountiesEditor: Kimberly Syre Email: [email protected]
Information: Phone 949-387-9046 and Fax 949-266.8461
IN ThIS ISSuE
President’s MessagePAGE 1
Engineer’s CornerPAGE 2
May 21Vendor Night and GMP Expo
Featuring a Technical Session“FDA Enforcement & Recalls”
by FDA Director, Alonza CruseFree for All To Attend
Exhibit Tables AvailablePAGES 3-5
FDA Co-SponsorsISPE June CGMP Conference
PAGE 6
Chapter is Forming Rock Group PAGE 7
ISPE Releases Updated Water and Steam Guides
PAGE 8
May 8 - City of Hope Tour with cGMP and Validation Seminar
PAGES 9-10
Chapter Board of DirectorsPAGE 11
Photos from March MeetingPAGE 12
ISPE Annual Meeting DetailsPAGE 12
Winery Tour PhotosPAGE 13
New MembersPAGE 14
ISPE Event CalendarPAGE 15
I am pleased to announce that Alonza E. Cruse, Director, FDA’s Los Angeles District Office will be the speaker for our Chapter’s GMP Expo (Vendor Night) on May 21st at the Petersen Museum in Los Angeles. Mr. Cruse is responsible for providing executive
leadership to one of the largest District Offices within FDA’s-Office of Regulatory Affairs. Mr. Cruse implements, manages and evaluates FDA’s regulatory operations within the District which is comprised of the State of Arizona and Southern California including the ports of Los Angeles, Long Beach and an Int’l Mail Facility. He provides the Executive leadership and technical direction to a multidisciplinary staff in the execution of investigations, enforcement and compliance programs and in the District’s day-to-day management. Please join us for Mr. Cruse’s presentation entitled “FDA Enforcement and Recalls”. We are very excited and honored to have him present to our group and have decided to make the session free for all attendees. See inside the newsletter for registration instructions. Another upcoming program is being held on May 8 at the City of Hope, hosted by our Chapter’s Past President, Matthew Atwong, Engineering Manager at City of Hope. Technical presentations will be given by Brian Cantwell of DPR Construction and Dr. Charles Heldebrant of PSC Biotech Corp, who will cover cGMPs, validation and risk assessment. The LA Chapter is also pleased to announce the following new ISPE Board Members: Matt Bauer of Neutrogena Corp/J&J; Russell Early of PSC Biotech Corp; Nick Haycocks (Commissioning & Qualification COP) of Amgen; Gary Incorvia (PCC Examination Development Committee) of Amgen; Klaus Krause (GAMP COP) of Allergan, Inc.; Alex Mendoza of Baxter; Rachel Skiba of DPR Construction and Margaret Stava of Laboratory Equipment Co. We have also asked some of our active Past Presidents to join the Board again to help the Chapter: Paul Crissman of Biotechnical Solutions and Denise Luckhurst of DL Engineering. These new Board Members are committed to be involved and ensure the success of the ISPE Greater Los Angeles Chapter. We wish you the best of success for 2012, please let us know how we can provide better pro-gramming and more value to the Greater Los Angeles Chapter Membership.
President’s Messageby John Clapham of PSC Biotech
www.ispe.org/greaterla
Rudolph and Sletten (R&S) hosted the March meeting (see more photos inside the newsletter.) (L-R) Board Members John Clapham, Denise Luckhurst, Scott Tiedge, Jan Karl, (R&S cut out of Curtis the Superintendent), Speaker Dr. Barry Holtz, Stu Levenshus, Kimberly Syre, Paul Crissman and Matthew Atwong.
2
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Engineer’s Cornerby Denise Luckhurst, PE, DL Engineering
How do we represent ourselves as engineers? Do we cry “wolf” when there’s really nothing wrong? Maybe we have cried “wolf” once too often and created a situation where our employers no longer believe us. Engineers are cautious people. When there is something to be concerned about, we are concerned. When there is something to be alarmed about, we
are. In most aspects of life, there is a certain amount of risk. When you tell your boss (who – gasp! - may not be an engineer), that this newly installed WFI system works fine now, but there is a chance an operator could get burned if the pump were to rotate backwards, causing the flows to change with hot water flowing into an ambient loop. You start it up ok, the maintenance staff and production team are trained and it’s out of your hands. They don’t remember the risk you mentioned. The equipment runs fine and nothing goes wrong. On your next project, the same thing happens. The process gets started up and the equipment works, even though you warn people that if that steam is allowed to cool down with all the valves closed, it will create a vacuum powerful enough to completely collapse that tank. That used tank somebody bought for such a great price didn’t come with any paperwork. Is it rated for full vacuum? You’re not sure, but you operate it carefully and nothing goes wrong.
You have worked long and hard to find that perfect o-ring that you know will work under normal process conditions. However, this is a very cold day in Florida and the possibility exists that a small liquid hydrogen leak has been created in another part of the system. The weather alone might have created a low temperature around your special gasket, but the hydrogen leak for sure has chilled things too far. You tell your bosses that this is not a good situation. There is a risk that this gasket may fail under this super-cold condition. Your boss says he will consider that. You stress that this really is a problem, not just a matter of concern. Once again, your boss says “I’ve got it.” He knows you are always too conservative. You always are concerned about the risks surrounding your work. However, the next thing you know, that shuttle launch takes place under conditions that were not been fully evaluated. Everything seems to be going well, however, right up until the launch commander calls for “Throttle up!” The next thing you know, seven astronauts are hurtling back to earth with no possibility of being rescued. You are devastated and outraged because no one listened to your warning.
So in your specific work environment, what would you do? Keep your eyes open; tell people about the risks that exist even when they don’t want to hear them; and in this day and age, document everything!
Author’s Note: This article was written in honor of the aerospace engineer who warned of a potential tragedy if NASA’s space shuttle Challenger launched in cold weather. This engineer, Mr. Roger Boisjoly, passed away two months ago at the age of 73.
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The Chapter’s 19th annual exhibit show and technical session will be held on May 21st at a new location, The Petersen Automotive Museum in Los Angeles featuring several unique galleries including: Sculpture in Motion: Masterpieces of Italian DesignScooters: Size Doesn’t Always MatterRacing GalleryHot Rod GalleryAlternative Power Vehicle GalleryHot Wheelsand Hollywood Gallery: Cars of Film and Television
We hope you can join us for a fun event at a unique location.
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ISPE Greater Los Angeles Chapter
May 21, 2012 Annual Vendor Night “GMP Expo” Exhibit Show
Featuring a Complimentary Technical Session: FDA Enforcement and Recalls
Presented by Alonza Cruse, District Director, FDA Los Angeles District
3
Exhibit Tables AvailableFree to Attend FDA Seminar Free to Walk the Show
Register Online at:http://www.atdevents.net/register.php
Or Email Rob Fleming:[email protected]
Alonza E. CruseDistrict DirectorU.S. Food and Drug AdministrationLos Angeles District Office
Alonza E. Cruse is the Director, FDAʼs Los Angeles District Office where his responsibilities includes providing executive leadership to one of the largest District Offices within FDAʼs-Office of Regulatory Affairs. Mr. Cruse implements, manages and evaluates FDA's regulatory operations within the District which is comprised of the state of Arizona and southern California including the ports of Los Angeles, Long Beach and an Intʼl Mail Facility; and provides the Executive leadership and technical direction to a multidisciplinary staff in the execution of investigations, enforcement and compliance programs and in the District's day-to-day management.
Mr. Cruse assumed his current position in October 2000. Prior to assuming his current position, Mr. Cruse was the Director, Import Operations in FDAʼs-New York District Office. He serves on numerous committees within FDA including the Medical Device Field committee and the Import Programs committee.
Alonza also works with a number of other organizations including serving on the Board of Directors for the Greater Los Angeles-Federal Executive Board. He is a past Chairman of the organization.
Alonza also serves on the Combined Federal Campaign - Local Federal Coordination Committee. This committee is responsible for overseeing and directing the yearly campaign where federal employees can make charitable contributions to charities. The Combined Federal Campaign is the only authorized solicitation of employees in the Federal workplace on behalf of charitable organizations.
Mr. Cruse holds a B.S. Degree in Medical Technology from York College and is a graduate of USDA's Graduate School - Executive Leadership Program.
FDA, Los Angeles District Office19701 Fairchild, Irvine, CA 92612
[949] 608-4414[949] 608-4417 fax
Speaker Bio
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FDA Enforcement and RecallsTechnical Session at GMP Expo (Vendor Night)
Speaker Bio
Vendor Night “GMP Expo” Schedule3:30 - 4:00 pmTechnical Session Check In
4:00 - 5:00 pm FDA Enforcement & Recalls Technical Session
2:30 - 4:00 pmExhibitor Set Up
5:00 - 8:30 pmExhibit Show Hours
Registration InstructionsTo Select Your Table and Receive an immediate receipt, use our on-line registration: http://www.atdevents.net/ispela.php
If you have an account on our system, please log on and register for the event. If you do not have an account, you can set up a new account using letters (not numbers) as your username. Please email Rob Fleming at: [email protected] if you need help logging on, setting up an account or to retrieve your username and password.
Registrations can also be faxed using this form with credit card payment. Fax to 949-266-8461.
If paying by check, please mail your check made payable to: ISPE Greater Los Angeles Chapter, 5319 University Dr., Suite 641, Irvine, CA 92612. ISPE LA Federal Tax ID #95-4452996
Name Badges will be given at the event. Contact Kimberly Syre: [email protected] or call 949-387-9046 with any questions.
ATTENDEE AND EXHIBITORREGISTRATION FORM
ISPE Greater Los Angeles Chapter19th Annual Vendor Night “GMP Expo” - May 21, 2012
Petersen Automotive Museum • 6060 Wilshire Blvd., Los Angeles, CA 90036323-930-CARS
FDA Enforcement and Recalls Technical Session:
___ Free for All Industry Professionals
Visit the Table Tops___ Free For All Industry Professionals
Exhibitor Table Top Cost: ___ $695 Regular Rate ___ $50 ElectricityList your Top 10 Table Choices Here:_____________________________Note: All exhibit tables are 6ʼ long by 2.5ʼ wide. Maximum Height: 60”/Maximum Width: 72”. Everything must fit on your table top (not on the floor or wall).
First Name: !
Last Name: !
Company: !
Title: ! !
Address: !
City/State/Zip: ! ! :
E-Mail: !
Tel: Fax:
Exhibitors: Please List Your Company Coordinator. We will copy your coordinator with the email confirmation package.
Coordinator Name: !
E-Mail:!
5
FDA to Co-Sponsor June CGMP Conference in Baltimore
The Food and Drug Administration (FDA) will co-sponsor the upcoming “Redefining the ‘C’ in ‘CGMP’” Conference in Baltimore, Md. USA on 4 – 5 June 2012. The conference is the first joint ISPE-FDA conference focused on CGMP issues.
The conference will feature a new format with a number of audience-participation and interactive sessions. A Hot Topic Discussion Forum between attendees and regulators will feature discussion on critical industry issues, concerns and collaboration. A mixed panel of FDA and industry leaders will also answer the industry’s most pressing questions during a moderated “Meet the Press” session. Topical plenary and education sessions will be featured throughout the two-day event.
“This first annual co-sponsored conference reflects ISPE’s commitment to engaging its Members, companies and global regulato-ry agencies in dialog around critical problem-solving and learning,” said ISPE’s president and CEO Nancy Berg. “As the indepen-dent pharmaceutical manufacturing association, ISPE is dedicated to strengthening industry through relevant technical education, training and networking. This new conference hits the mark, assembling the entire supply chain to discuss industry’s commitment to identifying and adopting quality and manufacturing techniques that continue to deliver a safe, consistent and available drug supply.”
“FDA is very excited to be working on this joint conference,” said Steven Lynn, Acting Director, FDA/CDER/Office of Compliance/ Office of Manufacturing and Product Quality (OMPQ). “Our goal is to make this a highly collaborative Agency and Industry confer-ence, where we can come together to discuss the current and future state of CGMPs in the quest to ensure high-quality/fit-for-use drugs are continually available to the community that we serve.”
More information on the Redefining the “C” in “CGMP” Conference is available at www.ISPE.org/2012CGMPCompliance.
6 –7 June Baltimore, Maryland USA
Designing, Implementing and Maintaining Pharmaceutical Supply Networks
Ensure high quality, reliability and secure product delivery to patients! Gain insight in the critical aspects of the Supply Network from around the world. Hear regulatory and senior level industry experts address current challenges in the global support network. Plenary Sessions and networking events are also included.
Customize your experience by attending either of the following tracks.• Designing and Establishing Supply Networks • Maintaining and Optimizing Supply Networks
Extend Your Stay and Attend Valuable Training on 4 – 5 June• GAMP® 5: A Risk-Based Approach to Process
Control Systems• Sterile Product Manufacturing Facilities – New
Course and Guide!
Register Today and Save!www.ISPE.org/SupplyChainNetworkConference
Sponsorship and Table Top Exhibit Opportunities Available
HOST SPONSOR PLATINUM SPONSOR SILVER SPONSOR SILVER SPONSOR
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7
Attention Rock Star Wannabes
Open call for all musicians interested in putting together a night of Rock ‘n’ Roll fun in the first ISPE West Coast All Star
(sic) Jam. Anyone looking to release that inner “Iggy” is encouraged to contact Scott Tiedge of Flotek for further info. -
949.770.5899 or email: [email protected]. Our goal is a live performance in South Orange County to raise funds for
local charities. NO DISCO.
ISPE 2012 Training Series
Classroom Training ISPE is offering a variety of Training Courses throughout the year to allow you the opportunity to enhance your career. Each course is taught by ISPE Members who are experts in their fields and face the same daily challenges you do. You will also utilize recently published ISPE Guidance Documents to enhance your expertise.
Upcoming Training Courses:
Sponsorship and Table Top Exhibit Opportunities Available
www.ISPE.org/Training
San Francisco, California USA11 – 14 November 2012Turning QbD Into a Reality (New Course and Guide), Quality Risk Management (New Course) and GAMP® 5
Tampa, Florida USA3 – 6 December 2012 Water (New Course), Modern C&Q, Cleaning Validation and QRM (New Course)
FACILITIES AND OPERATIONS Baltimore, Maryland USA 4 – 7 June 2012Turning QbD Into a Reality (New Course and Guide), Process Validation, Sterile Manufacturing (New Course and Guide) and GAMP® 5 Process Control
FACILITIES AND OPERATIONS Brussels, Belgium 19 – 20 September Facility Project Management (New Course), GAMP® 5, Turning QbD Into a Reality (New Course and Guide) and Quality Risk Management (New Course)
FACILITIES AND OPERATIONS Chicago, Illinois USA 24 – 27 SeptemberWater (New Course), Sterile Manufacturing (New Course), Facility Project Management (New Course), Clinical Trial Materials (New Course), GAMP® 5 and HVAC
ISPE Releases updated Water and Steam Systems Baseline® Guide
--Guide has been FDA reviewed and addresses ten years of changes in regulations and industry practices --
ISPE has released the long-awaited ISPE Baseline® Guide Volume 4: Water and Steam Systems (Second Edition). The revised and expanded second edition builds on the ground-breaking Water and Steam Systems Guide first published ten years ago. The second edition has been completely revised to address changes in industry practices and global regulations over the past de-
cade. Additionally, this comprehensive, industry-driven document will promote consistent and practical interpretation of regulatory requirements for water and steam systems worldwide. It includes tools to help pharmaceutical manufacturers meet safety require-ments while avoiding unnecessary cost.
This Guide, which is the only comprehensive guidance of its kind, aims to assist with the design, construction, operation, and maintenance of new water and steam systems that meet current Good Manufacturing Practices (cGMPs) and comply with existing regulations and related guidance. The Guide was written by a global team of critical utilities experts with a combined experience of more than 500 years. Much of the team responsible for the original Water and Steam Systems Baseline Guide has returned to con-tribute to the revised Guide, providing continuity and longevity of vision to the Guide’s contents. The Guide also has been reviewed by the US Food and Drug Administration (FDA), and their comments have been taken into consideration in the final version of the Guide.
“In light of the fact that ISPE has literally ‘written the book’ on water and steam systems, we know the industry is highly interested in this revision. We’re glad to say that it is complete, the FDA has reviewed it, and the Guide is headed to the printer,” says Cameron Sipe, leader of the Task Team responsible for authoring the Guide. “Water is involved in the manufacture of every pharmaceutical product in every facility around the world, so the updates in this Guide are incredibly important to the manufacture of safe, pure medicines for patients all over the globe.”
The ISPE Baseline® Guide: Water and Steam Systems (Second Edition) has been expanded to include new chapters on labora-tory water systems and the latest theories and industry practices addressing the rouge phenomenon in high purity water and pure steam systems. New chapters also cover microbiological considerations, such as biofilm formation, use of sanitizers, sampling, testing, and control levels, as well as the overall impact of microbial considerations on unit operations and finished water.
For more information on ISPE Guidance Documents, including the FDA-reviewed Baseline Guides series, or to order copies in either bound or electronic form, visit www.ISPE.org.
8
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May 8 Event at City of hopeThe Principles of Implementing Good Manufacturing Practices
(cGMPs) and Validation of FDA Licensed Facilities
Join us on May 8th at City of Hope for our next ISPE LA Chapter event. The session will address the necessary cGMP princi-ples associated with the design, construction and commission-
ing of a FDA licensed facility. The Validation session will address the implementation of the qualification program, necessary docu-mentation and executions of all qualified systems and equipment.
Good Manufacturing Practices (GMPs)What are they? Who do they apply to? Why are they required? Who regulates them? When do they start and how are they controlled? The session will cover the following aspects: Design, Construction and Commissioning - Documentation (TOP’s).
Validation What is it? Why is it required? The Purpose. When does it start on a project? Who does it? Key Elements of Validation: Qualifica-tion, VMP, SOPs, IQ, OQ, PQ Protocols, Executions, Final Reports /Stability Lots and BLA License.
Program Manager: Frank haughey, Director, DPR Construction
Presenters: Brain Cantwell of DPR Construction Inc. has 27 years experience in the design, construction and commissioning of validated facilities.
Charles hildebrandt, PhD of PSC Biotech has over 35 years experience in the qualification of validated facilities. He started his career at Abbott Scientific Products Division (ASPD) in 1975.
The event is divided in sections, starting with a tour of City of Hope, followed by networking, dinner and an evening program. We understand that the tour portion starts earlier than we normally would begin an event; this is due to the staffing requirements at City of Hope. We encourage you to join us for some or all of the event.
Schedule3:30 - 4:00 pm MeetMeet at City of Hope Parking Lot2240 Buena Vista Ave., Duarte, CA
4:00 - 5:00 pm City of hope ToursThose arriving by 4pm will be escorted to a meeting area. Then we will break into two groups. The first group will leave for a tour, the other will hear about the GMP Lab at City of Hope. Once the first group arrives back, the second group will start the tour and the first group will hear about the GMP Lab.
5:00 - 5:30 pm Tour Groups Escorted Group goes to Beckman Research Institute for Dinner and Presentations
5:30 - 6:30 pm Networking and Dinnerat Beckman Research Institute at City of Hope1500 East Duarte Rd, Duarte, CA
6:30 - 7:30 pm Presentations
Building Great Things.
9
Thank You To our adverTisers
Advertise WithISPE Greater Los Angeles Chapter
Cost: $125 Per Issue (business card ad)
Contact Kimberly Syre at [email protected] More Information
Registration FormRegister Online at: http://www.atdevents.net/ispela.php
To Register via Fax, Complete this form and Fax it to (949) 266-8461. To Pay by Check: first fax your registration form to (949) 266-8461, then mail your check one week prior to the meeting to ensure it is received in time. Make checks payable to: ISPE Greater Los Angeles Chapter, 5319 University Dr., Suite 641, Irvine, CA 92612. Cancellations must be received in writing via fax or email to: [email protected] by May 1 for refund. After the cancellation date if you have reserved a space but do not attend, your pay-ment MUST be remitted, however, if your alternate is a non-member, they will be required to pay the difference in fees.
❑ ISPE Member $35 ❑ City of Hope Employees Free (up to 10) ❑ Non-Member $50 ❑ ISPE Student Members Free
MEMBER INFORMATION
First Name:
Last Name:
Company:
E-Mail:
Title:
Address:
City:
State: Zip:
Tel Number:
Fax Number:
CREDIT CARD PAYMENTType of Credit CardCircle One
Name on Card: Credit Card #: Exp Date: Signature:
The Principles of Implementing cGMPsGood Manufacturing Practices and
Validation of FDA Licensed Facilities
Tuesday, May 8, 20123:30 - 7:30 pm
Location: City of HopeTour: 2240 Buena Vista Ave., Duarte CADinner and Presentation: 1500 East Duarte Rd., Duarte CA
If Registering as a Member, Please Supply Membership Information
ISPE Member:
Chapter Affiliation:
Schedule3:30 - 4:00 pm Meet at City of Hope Parking Lot, 2240 Buena Vista Ave., Duarte, CA
4:00 - 5:00 pm Tours-Thosearrivingby4pmwillbeescortedtoameetingarea.Thenwewillbreakintotwogroups.Thefirstgroupwillleaveforatour,theotherwillhearabouttheGMPLabatCityofHope.Oncethefirstgrouparrivesback,thesecondgroupwillstartthetourandthefirstgroupwillhearabouttheGMPLab.ThegroupwillbeescortedtoBeckmanResearchInstitutefor the second part of the program.
5:30 - 6:30 pm Networking and Dinner at Beckman Research Institute at City of Hope, 1500 East Duarte Rd, Duarte, CA
6:30 - 7:30 pm Presentations
ISPE LA Board of DirectorsPosition Name Company Telephone E-mailPresident John Clapham PSC Biotech Corporation (626) 792-1649 [email protected]/Continuous Improvement Mary Clare Smithson, PE Jones Lang LaSalle Americas (805) 755-4777 [email protected] Brent Oswald c | a Architects (562) 355-6118 [email protected] Wilson Hsing Anchen Pharmaceuticals (714) 360-9504 [email protected]/Marketing/Membership Stephania Armani, PhD Children’s Hospital LA (323) 361-2188 [email protected] Expo Matt Bauer Neutrogena Corp/J&J (310) 216-5341 [email protected] Student Affairs Andrew Chang Anchen Pharmaceuticals (714) 336-8111 [email protected] Professionals Chair Russell Early PSC Biotech Corporation (909) 239-1499 [email protected]/Marketing/Membership Tom Golden PSC Biotech Corporation (805) 908-2230 [email protected]/Marketing/Membership Frank Haughey DPR Construction (949) 255-0061 [email protected] Co-Chair Nick Haycocks Amgen (805) 313-0082 [email protected] Chair Gary Incorvia Amgen (805) 447-3799 [email protected]/Marketing/Membership Jan Karl Rudolph and Sletten, Inc. (949) 223-6808 [email protected] Co-Chair Klaus Krause Allergan, Inc. (714) 246-2379 [email protected] Alex Mendoza Baxter [email protected]/Golf Chair Bill Neal PSC Biotech Corporation (541) 588-0706 [email protected] Expo Rachel Skiba DPR Construction (949) 606-5875 [email protected] Margaret Stava Laboratory Equipment Co (562) 355-5859 [email protected] Program Chair Dona Tseng Baxter BioScience (818) 550-8575 [email protected] Stan Wendzel BioRealty, Inc. (949) 498-2391 [email protected] President/Programs Paul Crissman Biotechnical Solutions (805) 844-1103 [email protected] President Lanie Geldert EwingCole (949) 417-6487 [email protected] President/Finances Stu Levenshus M.D. Stainless Services (562) 904-7022 [email protected] President/Communications Denise Luckhurst, PE DL Engineering (818) 525-1827 [email protected] President/GMP Expo Scott Tiedge Flotek South (949) 770-5899 [email protected] Manager Kimberly Syre Attention To Detail (949) 387-9046 [email protected]
Validation & Calibration ServicesValidation Equip. RentalsWe CAL V2000s, IRTDs, LTRsFacility MonitoringWireless DataloggersGMP BioPharma Storage
888-433-MASY (6279) www.masy.com
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VALIDATION
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Nicki HallCell: [email protected]
Photos from March MeetingCase Study of Caliber Biotherapeutics Facility
Design/Build of Flexible Facilities
12
Thank you to Jan Karl and Rudolph and Sletten in Irvine for hosting the Chapter’s March meeting. Over 40 Members met
to hear Dr. Barry Holtz, the Chief Science and Technology Officer at Caliber Biotherapeutics present a Case Study for the
Design and Build of Flexible Facilities. Thank you to Dr. Holtz and to Paul Crissman, the program chair for an informative
presentation.
WWW.ISPE.ORG/2012ANNUALMEETINGConnecting a World of
Pharmaceutical Knowledge
E x p e r i e n c e a N e w F o r m a t t h a t i s P o w e r P a c k e d a n d T o p i c - S p e c i f i c !
THROUGH INNOVATION AND TRANSFORMATION
2012 ISPE ANNUAL MEETINGSAN FRANCISCO, CAL IFORNIA USA MARR IOTT MARQU IS SAN FRANC ISCO
11 – 14 NOVEMBER
GLOBAL
GMP SOLUTIONS
S A V E T H E D A T E
LA and SD Chapters Gather for Joint Social EventWinery Tours in Temecula
2012 started with a fun event bringing together ISPE
Members from the Greater Los Angeles and San
Diego Chapters. Limo buses picked up attendees at
the Santa Ana and Oceanside train stations and in Old Town
Temecula for winery tours in Temecula. It was a beautiful
day in January when we visited the vineyards at Leoness
Cellars. The group then headed to Oak Mountain Winery for
a gourmet pizza lunch and wine tasting. We were treated to
music by Jonny Tarr from Encinitas. Following lunch we had
a final tasting at the beautiful hilltop estate of Gershon Bachus
Vintners.
If you did not make our event this year, we hope you can join
us for a similar event next year.
Thank You SponsorsISPE San Diego and Los Angeles Chapter Temecula Winery TourJanuary 26, 2012
Premium Pour Sponsors:
Limo Bus Sponsor:
Winery Sponsors:
13
Luis Alvarado, Staff Engineer, J&J NeutrogenaMichael Annett, Regional Sales Manager, Aquafine Corp
Chander Badwal, Associate Director, Bristol-Myers Squibb Co.Sabuj Banerjee
Antoinette Bunkley, Project Manager, GenslerVijay Chiruvolu, Director, Amgen
Judith Corpuz, Quality Staff Engineer - Micro, Johnson & JohnsonStephen Hsu, Student, Keck Graduate Institute
Justin Klein, Client Service Rep., Johnson Controls Inc.Alexander Le, Validation Engineer, Gilead Sciences
Carla Lundi, Investigator, FDADanny Makhijani, Engineering Consultant, PSC Biotech
John McDowell, Controls Engineer, Mangan Inc. Stephen Hsu, Keck Graduate Institute
Michael Peerenboom, Sr. Manager, Lewa Inc.Manuel Perez, Outside Sales Engineer, Endress+Hauser
Mike Ray, VP North America Sales & Service, Auqafine CorpKristine Taber, Quality Assurance Manager, Gilead Services
Brandon Wong, Student, University of California - Los Angeles
Welcome New Members January - March, 2012
West Coast Operations Manager
400 Oyster Point Blvd, Suite 520South San Francisco, CA 94080
650.588.2660 of�ce650.588.2857 fax646.283.7987 cell
Maura Lynch
Toll-Free (888) 242-0559
www.propharmagroup.com
COMPLIANCE SERVICES VALIDATION
AUTOMATION PROGRAM/PROJECTMANAGEMENT
In A SeaOf Change,Some ThingsAre Constant.
Regional Manager - Dori Carlson1522 South Ave., Lewis Run, PA 16738800-542-0650 • www.alleghenybradford.com
Skids • Tanks • Valves • Pumps Heat Exchangers • Filter Housings
ALLEGHENY BRADFORDCORPORATION
Engineering
Architecture
Process Technology
Process Automation
Systems Integration
Construction Management
Startup & Commissioning
Procurement
Project Management
Nino Borsoni, PMP - Senior Vice President
c. 925.348.2157
p. 562.256.8660
f. 562.256.8699
Foster Wheeler Biokinetics, Inc.Susanne Lage’ Cost
VP, Business Development, Western RegionWalnut Creek, CA 94597
Phone: [email protected]
• Process Development & Scale-Up • Critical Utility Design • cGMP Upgrades • cGMP Facility Design • Debottlenecking • Custom Process Equipment • Commissioning/Qualification/Validation 14
ISPEGREATER
LOS ANGELESChAPTER
5319 University Dr.Suite 641
Irvine, CA 92612949-387-9046
Fax:949-387-9047
or 949-266-8461
For Newsletter Advertising Deadlines/Costs:
www.ispe.org/LosAngeles_______________________________
For additional ISPE Educational Offerings and Publications
www.ispe.org
ISPE is a Society of pharmaceutical
professionals who use expert knowledge to create high-quality, cost-effective
GMP solutions.
Photos by Kimberly Syreand Stock Photos from
[email protected]. Schmitz
@sdmix@sebastianreuter
2012 ISPE Event Calendar1-3 May INTERPhEX 2012 Javits Center, New York, New York www.interphex.com/
8 May City of hope Tour and Implementing cGMPs and Validation of FDA Licensed Facilities at City of hope, Duarte, CA
21 May Vendor Night and GMP Expo 19th Annual Exhibit Show and Technical Session FDA Enforcement and Recalls, Presented by Alonza Cruse, FDA Los Angeles District Director Free To Attend Exhibit Tables Available at Petersen Automotive Museum, Los Angeles, CA
4-5 June Redefining the “C” in CGMP Baltimore, MD www.ispe.org
6-7 June Pharmaceutical Supply Networks Baltimore, MD www.ispe.org
20 June Joint Meeting with Lean Construction Institute (LCI) Integrated Project Delivery: Case Study Gonda Research Building, City of hope National Medical Center at Amgen, Thousand Oaks
25 July Dendreon Tour & Presentation at Dendreon, Seal Beach, CA
20 September Golf Tournament
17 October Evening Event TBD
11-14 November ISPE Annual Meeting
12 December Evening with an Industry Executive CALL FOR SPEAKERS We are looking for industry executives to invite to speak Pharmaceutical company CEO, VP of Engineering or Facilties, Plant Manager, etc. Please contact Kimberly Syre, Chapter Manager If you have any speaker ideas ([email protected])
All events subject to change due to availabilityof venue and speakers.
For More Details please visit ISPE Los Angeles Web sitewww.ispe.org/LosAngeles
and ISPE’s Global Calendar
www.ispe.org15
