ISPE SF Newsletter December, 2014 ISPE San Francisco Bay Area Chapter Newsletter December 2014 Save These Dates! All ISPE California Events Featured in Emails 11 December 2014 ISPE San Francisco Chapter Dinner Meeting at DoubleTree Berkeley Marina 17 December 2014 ISPE San Francisco Chapter YP Ugly Sweater Holiday Social at The Patio in Palo Alto 2015 Working Calendar (subject to change) 21 January 2015 ISPE LA Chapter Program 29 January 2015 ISPE San Francisco Chapter CEO Night 30 January 2015 ISPE San Diego and LA Chapter Joint Temecula Winery Tour 26 February 2015 ISPE San Diego Chapter Electrical Utilities and Water Infrastructure 10 February 2015 ISPE San Francisco Chapter Commuter Conference 18 February 2015 ISPE LA Chapter Program 21 February 2015 ISPE San Francisco Chapter Young Professionals Leadership Forum 12 March 2015 ISPE San Francisco Chapter Vendor Night and Student Poster Contest 18 March 2015 ISPE LA Chapter Program 19 March 2015 ISPE San Diego Chapter Who's Coming, Who's Going in San Diego 2 April 2015 ISPE San Diego Chapter Networking Bowling Event 8 April 2015 ISPE LA Chapter Program 23 April 2015 ISPE San Francisco Chapter Joint Lunch Meeting with DBIA (Design-Build Institute of America) at Marriott SF Union Square President's Message By Simon Forder, Principal Consultant and CEO Hyde Engineering + Consulting, Inc. Hello All, I hope you are well and had an enjoyable Thanksgiving. I wanted to take a few moments and talk a little about what we would like accomplish this year in the ISPE San Francisco/Bay Area Chapter. There are three areas we would like to focus on: 1. Membership - As you may or may not know, our Chapter's membership level is lower than in past years. There are many reasons we hear for this including "my company will not pay for membership" or " We do not see the value". We will need to better understand and address these concerns in the coming year and in doing so, get back to our past membership levels. Our goal this year is to increase by 10-15%. We currently have 763 Members in the Chapter. We would like to add an additional 80 Members by the end of summer 2015. As part of this effort, you can help us achieve this goal. Speak with your colleagues and associates about becoming an ISPE Members. Tell them why you participate and what you see as the value of an ISPE membership. 2. Programs/Commuter Conferences - We would like to increase the technical content and relevancy of Chapter programs and Commuter Conferences. One of the main goals of ISPE is to provide technical training and up-to-date knowledge to the industry, strengthening the technical aspects of our programs and conference will help address this. We welcome feedback or your ideas of what topics you would like to see developed as a program or Commuter Conference. 3. Social media - We plan to increase and establish our social media outlets as an organization. Many folks have commented on the fact that we do not have our a LinkedIn page. We also do not tweets about our upcoming events to help promote the activities of the Chapter. We would like to establish a more focused effort in this area in the coming months. The first thing to be addressed will be to "plan" our online presence and then look at putting it together. We welcome any thoughts or volunteers in this area! As you can see, we have our work cut out for us this year! I would encourage everybody to help us grow our membership, provide feedback and ideas on programs and conferences, and give us your ideas on growing our online presence. Enjoy the holidays and we will see you in the new year, Regards Simon Forder For information on San Francisco / Bay Area Chapter events, or to become a Member of the Chapter, contact Chapter Manager Kimberly Syre by telephone at +1-949-387-9046 or by email at ksyre@cox.net. Chapter President Simon Forder can be reached at simon.forder@hyde-ec.com. ISPE SF Newsletter December, 2014 1 May 2015 ISPE San Diego Spring Golf Tournament La Costa 7 May 2015 ISPE LA Chapter Vendor Night 19 May 2015 ISPE San Francisco Chapter Commuter Conference 24 May 2015 ISPE LA Chapter Program 18 June 2015 ISPE San Francisco Chapter Facility Tour for Members Only ISPE San Francisco/Bay Area Chapter Presents Bayer HealthCare Building 60 Renovation Project Case Study and Lessons Learned With Panel Discussion Dinner Meeting Thursday, December 11, 2014 Event Location DoubleTree Hotel Berkeley Marina 200 Marina Blvd., Berkeley, CA 94710 Speakers/Panelists: Joerg Blaesing, Head Project Management/Engineering Bayer Technology Services 25 June 2015 ISPE San Diego Chapter CEO Night Trevor Auer, PE, Associate, Core Team Leader, CRB 15 July 2015 ISPE LA Chapter Program Schedule 5:00 - 6:00 pm Registration and Networking Reception 16 July 2015 ISPE San Francisco Chapter Fun Day Golf Tournament and Winery Tours, Chardonnay Golf Course Napa, CA 23 July 2015 ISPE San Diego Chapter Networking Event 6 August 2015 ISPE San Diego Chapter Vendor Night 7 August 2015 ISPE San Diego Chapter Golf Tournament 18 August 2015 ISPE San Francisco Chapter Commuter Conference 19 August 2015 ISPE LA Chapter Program 3 September 2015 ISPE San Diego Chapter Networking Event 16 September 2015 ISPE LA Chapter Program 24 September 2015 ISPE San Francisco Chapter Evening Meeting 7 October 2015 ISPE San Diego Chapter Clinical to Commercial Meeting 8 October 2015 ISPE LA Chapter Program 15 Oktober 2015 ISPE San Francisco Chapter Oktoberfest End of October 2015 ISPE San Diego Chapter & Biocom Joint Facilities Reception 3 November 2015 ISPE San Francisco Chapter Commuter Conference 4 November 2015 ISPE LA Chapter Evening with Industry Executives Isidro Reyes, MEP Specialist, Dome Construction 6:00 - 7:00 pm Dinner 7:00 - 8:30 pm Panel Discussion Download the event flyer Abstract: How do you implement a significant renovation project for a new product directly across the corridor from where you are concurrently manufacturing your product? How do you evaluate and mitigate the risks to business continuity as well as alternatives to the significant capital investment required? How do you execute design and detailing activities in a space-constrained facility with limited access? Bayer HealthCare, LLC faced all of these challenges and more in bringing its next generation rfVIII therapy into its existing cGMP commercial manufacturing building in Berkeley, CA. As the $100 million manufacturing investment in Berkeley that created a lot of buzz in the local news in 2010, new rFVIII Project presented unique opportunities for Bayer and its design, construction and validation team. This panel discussion with project representatives from Bayer, the designer and constructors will focus on the innovative approaches that the project team took to meet Bayer's project goals and objectives and some of the lessons learned along the way. Register Today! ISPE SF Newsletter December, 2014 8-11 November 2015 ISPE Annual Meeting Philadelphia, PA 3 December 2015 ISPE San Francisco Chapter Evening Meeting TBD 10 December 2015 ISPE San Diego Chapter Networking Event All events subject to change due to availability of venue/speakers. Join us for Young Professionals (YP) Ugly Sweater Holiday Social Wednesday, December 17, 2014 5:30 - 8:00 pm Event Location The Patio 412 Emerson Street, Palo Alto, CA 94301 To Register for Any ISPE LA, SD or SF Chapter Meetings Click Here ISPE's Global Calendar and Additional ISPE Educational Offerings and Publications: www.ispe.org Download the event flyer Cost: $5 for members Cost: $10 for non-members Come join us for an opportunity to meet other young professionals and enjoy a drink and appetizers on us. Please register online by Tuesday December 16th Any questions contact Marlene Meza at marlene.meza@grifols.com This event is for professionals in the biotech/pharma industry with 0 to 10 years experience. Members and Non-members are welcome. Register Today! ISPE SF Newsletter December, 2014 Overview of Student Tour of Novartis by Gunjan Patel, SJSU ISPE Student Chapter President Collin Dubois, SJSU ISPE Student Chapter Senator Thanks to our regional Chapter Vice President Karl Wilks, the ISPE SF Bay Area Student Chapters were granted the opportunity to attend an industry tour hosted by Novartis at their Vacaville production facility on November 6th. Considerable numbers of students from San Jose State University (SJSU), UC Berkeley and UC Davis attended to tour their facilities. The tour was hosted by Todd Johnson and Nancy Katindov of Novartis. A team of Novartis' experienced professionals in both utilities and production imparted great industry knowledge that cannot be presented in a classroom. The attending students were able to extend their acquired classroom knowledge to physical reality while learning how principles of GMP and GAMP are applied in industry, as they are both absolutely crucial to the drug manufacturing process; a consistent patient experience being the ultimate goal. Notably, the production facility was large enough to understand how production is scaled, yet small and organized enough for students to take it all in without being overwhelmed. With the majority of those attending coming from a chemical engineering background, students were familiarized with the mechanics of batch fermentation, separations and purification processes. Our visit was also made possible by circumstances that leave the future of the Novartis facility in some doubt, soon transitioning to Eli Lilly Animal Health. It is our sincerest wish, that those circumstances reach a happy conclusion soon. We shall always fondly recollect our visit to your facility, and for all the advantages that you so liberally bestowed we can only add, thank you. ISPE SF Newsletter December, 2014 Call for Proposals ISPE 2015 Annual Meeting ISPE is now accepting proposals for Education Sessions (90 minutes) and Innovation Showcase Presentations (25 minutes) for the 2015 Annual Meeting on 8 - 11 November 2015, in Philadelphia, PA. All proposals must be submitted online through the ISPE Abstract Studio Submission site by 16 February 2015. Selected sessions will be placed in one of five education tracks. ! End-to-End Supply Chain Management ! Facilities and Equipment ! Information Systems ! Product Development and Production Systems ! Regulatory Compliance and Quality Systems Quality initiatives, case studies, benchmarking data and technical solutions for all educations levels are encouraged. If you have any questions, please contact Marianne Bock at mbock@ispe.org. Highlights of ISPE Annual Meeting by Kimberly Syre, Chapter Manager Among the higlights of this year's ISPE Annual Meeting in Las Vegas was the news of this year's Graduate Student Poster contest winner, an ISPE SF Chapter Member, Jack Morel of UC Davis. Below he is accepting his award at the Membership luncheon with about 1,000 other ISPE Members. During the Membership luncheon, Genentech was awarded company of the year. ISPE also announced the following initiatives for 2015: * Focus on Drug Shortage Prevention * ISPE is engaged in an outreach to global regulatory agencies * New COP (Communities of Practice) section of the ISPE website - it's designed more like a social network where you can see the photo of other COP Members and their profile. It's easier to navigate and looks much nicer. * With new incentives to join (reduced fees, bundling publications with membership, gifts with membership), ISPE's membership is starting to rise again. * John Bournas (below) was announced as ISPE's new CEO. He speaks seven languages and will be located in the new ISPE Washington DC office, scheduled to be opened in 2015 ISPE SF Newsletter December, 2014 L-R: Victoria Smoke, ISPE VP of Administration/CFO, John Bournas, ISPE President/CEO and Alicia Montes, ISPE Sr. Director of Training. Sokhorn Yim of Genentech at ISPE's 5K run. Janette Buechler of Pharmatech (on right). (L-R) Sue Cost of Harris Group and Shannon Chesterfield Yonker of Exemplar Compliance. ISPE SF Newsletter December, 2014 Photos from Fun Day by Cynthia Wiggins of VERSA Engineering & Technology Thank you to Cynthia for posting her photos. To see all of the photos and to download your favorites, please click here. ISPE SF Newsletter December, 2014 Insight to Operation Global Leader in BioPharma Process Systems Support Northern California Office 48400 Fremont Boulevard Fremont, CA 94538 Tel. 510-683-6000 Fax. 510-683-6001 Contact: Mike Cables michael.cables@kinetics.net People | Process | Product cagents.com Commissioning Agents Inc USA | Canada | Puerto Rico | Europe | Asia astropak.com est. 1959 Call Today! 703.542.0608 Control Solutions for Evolving Plants... in the Life Science Industry and Industrial Process Automation Contact: Greg Banks, President 707.451.1100 Ext. 203 • Cell 707.330.5860 600 E. Main Street, Suite 200, Vacaville, CA 95688 • www.BanksIntegration.com Sandra Medlin (510) 290-1232 Cell smedlin@Sani-TechWest.com 1-800-726-4835 www.Sani-TechWest.com www.SaniSure.com 1020 Flynn Road Camarillo, CA 93012 COMPLIANCE SERVICES VALIDATION Chambers, sterilizers, warehouses CALIBRATION NVLAP Accredited and NIST traceable GMP STORAGE From -196°C to 70°C environments RENTALS/SALES For validation and calibration MONITORING Continuous, wireless solutions AUTOMATION 978.433.6279 | masy@masy.com | www.masy.com PROCESS DESIGN COMPLIANCE CIP/SIP CORE LAB VALIDATION PROGRAM/PROJECT MANAGEMENT 500 Airport Blvd., Suite 100 • Burlingame, CA 94010 Toll-Free (888) 242-0559 • Office (650) 320-1788 www.propharmagroup.com Brian Vaughn brian.vaughn@crbusa.com 760.496.3714 We Listen. We Deliver. www.crbusa.com 855.411.HYDE • HYDE-EC.COM CONSULTING | DESIGN | CONSTRUCTION | COMMISSIONING | QUALIFICATION ISPE SF Newsletter December, 2014 Welcome New 2014 ISPE Members Moustapha Adoum, Validation Engineer, Delta Project Management James Ahearn, Roche/Genentech Xavier Alcaraz, Principal, EORM Kerry Anderson, Principal Compliance Specialist, Genentech Inc Nicole Aneloski, Thermo Fisher Scientific Warren Bacat, Genentech Inc Warren Baker, Chief Executive Officer, Pharmatech Associates, Inc. Jerry Beers, Marketing and Business Development, Pharmatech Associates Adam Benzuly, Project Manager, Lend Lease Henry Berman, Division Sales Manager, Engineered Air Padma Bindingnavaley, CSV Strategy Auditor, Genentech Nils Blomquist, DPR Construction Andrea Bosshardt Chris Branan, Project Manager Ross Browne, Student, Stanford University Griselda Cardona, Project Engineer, Bayer Technology Services Jon Cassel, VP, Operations, Genomic Health Carlos Castro Izaguirre, Packaging Manager, Gilead Sciences Nitin Champaneria, Senior Technical Mgr, Genentech, a Roche Group Company Tate Chandler, Sr. Project Manager, XL Construction Marc Charles, Gilead Sciences, Inc. Brian Chase Lori Chelemedos, Sr. Technical Mgr., Genentech, Inc. Sandeep Chera, Student, San Jose State University Andy Cheung, Process Engineer, Foster Wheeler Anthony Chikere, Scientist, BioMarin Pharmaceuticals Inc Ankita Chitre, Head of Steriles, North America, External Quality, Genentech Inc Jeffrey Chu, Student, University of California-Berkeley Jack Commins, Sales, Clipper Controls Darwin Constantino, Student, University of California-Davis Phillip Contreras, Sales Engineer, M-I-C, Inc. Brian Conway, Sales, Owens Design James Cottle, Sales Manager, Dur-A-Flex, Inc Beatrice Curran, Director, Genentech Christopher Dalton, Sr Director - Governance, Risk & Compliance, ServiceNow Mark Danna, VP Sales and Marketing, Owens Design Serge Degrandpre, Sr Engineer Automation & Controls, Novartis Pharmaceuticals Jude Dike, Investigator, FDA Linh Do, San Jose State University Jillian Doherty, Student, UC Davis Collin Dubois, San Jose State University Robert Dubuc III, Outside Sales Engineer, Flotek Alfie Duque Alicia Eikenberry, Senior Structural Engineer, AEPC Group LLC Adam Entizne, Student, UC Davis John Espinosa, Senior Engineer, ACCO Engineered Systems Leto Farrales, Staff Engineer, Life Technologies Joe Fielding Kell Fong, Engineer, Versa Engineering & Technology Jeffrey Gosdigian, Sr Project Manager, DF Pray General Contractors Rudy Grant, Sr. Manager, Supply Chain & Manufacturing, Raptor Pharmaceutical Vanessa Guardini, Quality Systems Specialist III, Gilead Sciences, Inc. Kayhan Guceli, Genentech - Roche Senthil Gurumoorthi, Manager, IT Compliance, Gilead Sciences Frank Guzzardo, Sr Manager QA, Gilead Diane Hagerty, Vice President, Genentech Inc Barry Hamory, Senior Sourcer, Theranos Paula Hansen, Sr Project Engineer, Environmental Engineering & Contracting, Inc. Chithkala Harinarayan, Principal Quality Engr, Genentech Inc John Henley, Genentech, Inc Jon Hildreth, Student, Western Governors University Dwayne Hill, Onyx Pharmaceuticals Samuel Ho, Technical Services Engineer, Impax Laboratories Michael Huynh, Grifols Diagnostic Solutions Shawn Inks, Facilities Validation Manager, Gilead Sciences Juliana Ipuz, Account Manager, Charter Medical Jaydeep Jha Jessica Jimenez, Engineer, Banks Integration Judy Joice, VP Operations & Corporate Quality Assurance, DURECT Corporation Maryam Kacyra, Project Engineer, Bayer Technology Services Lief Kaiper, Business Development Manager, Degenkolb Engineers Sanjil Karki, Student/Intern, San Jose State University Laurel Khiabani, QA Validation Specialist, Pearl Therapeutics, Inc. Kenneth Kilborn, President/CEO, Kilborn & Associates Business Process Excellence JohN Klaric, Principal Biostatistician, Grifols Mikhail Krasner, Student, San Jose State University Samantha Kubeck, San Francisco State University David Kunz, Sales Engineer, Engineered Air Robert Lamorena, Manufacturing Engineer, Impax Laboratories, Inc. Joseph LaPoint, Account Manager, Caltrol Inc. Alexander Lee, Sr. Dir Global Mfg Tech Services, Impax Labs Maryann Lee, Consultant, ML Quality Consulting Henry Leong, Bio-Rad Laboratories Amy Leung, Process Engineer, Grifols Diagnostic Solutions Cecilia Leung, Learning Technology Manager, Genentech Roche Pei Lin Lin, San Jose State University Laura Ling, Medivation David Lopez, Quality Engineer, Boehringer-Ingelheim ISPE SF Newsletter December, 2014 John Luna, Manager, Biodecontamination Services, Steris Corporation Tung Luong, Account Manager, Asahi Kasei BioProcess Amy Ly, Student, UC Davis Maura Lynch, Operations Director, Delta Project Management Sara Magzoub, Engineer, Banks Integration Group, Inc. Corey May, Associate Facilities Engineer, BioMarin Pharmaceutical Inc George Medina, Account Manager, Restoration Management Company John Miles, Industry Account Manager, Rockwell Automation Tom Miller, Senior Director, Gilead Sciences, Inc. Jason Montplaisir, nora systems, Inc. Jack Morel, Student, University of California-Davis Alan Moyal, Sr Engineer, Genentech, Vacaville Vignesh Namburi-Murugesan, Research Assistant, Texas Tech University Sujatha Narayan, Principal Regulatory Program Director, Genentech Inc Aruna Natarajan, Associate Process Engineer David Nelson, Facilities, Bio-Rad Laboratories Duyen Nguyen, RA, Genentech Simon Overton, Staff Engineer, Life Technologies Jonathan Palomo, Facilities Supervisor, Asterias Biotherapeutics Hemal Panchal, Manufacturing Manager, Carbylan Therapeutics Irene Pang, Validation Engineer, Commissioning Agents, Inc. Nikhil Pargaonkar, Staff Engineer, Proteus Digital Health Inc. Jim Park, Architect Bakul Patel, Senior Validation Engineer, Grifols Diagnostic Solutions Gunjan Patel, Chemical Engineer, San Jose State University Sandeep Patel, Founder, Nexus Automation Thomas Pinedo, Consultant Chris Power Loan Quach, Manager QA CSV and Compliance, Impax Labs Don Rackham, QA Manager, Proteus Khalid Ramahi, Student, San Jose State University Kristine Marie Ramos, Student, University of California-Irvine Ayesha Rashid, Staff Engineer, Life Technologies Kathryn Reynolds, Western Allied Mechanical Brian Richards, Project Engineer, Bayer Yvonne Richardson, Head Global Quality System Processes & Subject Matter Expertise, Genentech Ki Nam Ro, Application Engineering Manager, Gilead Sciences, Inc. Vanessa Ruiz Vijay Sabesan, Engineer, Theravance Lorraine Sandoval, QA Associate Director, Ultragenyx Pharmaceutical Inc Marc Jeremy Santos, Sr. Engineer, Bayer Imad Sawaya, San Jose State University Shachi Sharma, Associate Director, Computer Systems, Bayer Healthcare Sarah Shtargot, Student, San Jose State University Peter Shwonek, Calithera Biosciences, Inc. Debbie Silva, Laboratory Furniture Specialist, ISEC, Inc Priscilla Spradlin, Marketing Assistant, CRB Engineers Derek Stenhouse, Genentech Inc Lauren Streb, Head of DS Transfers, Genentech / Roche Joshua Sumabat, Student, San Jose State University Neti Tailor, Sr Validation Engineer, Impax Laboratories Inc Lawrence Tam, Sr Quality Systems Specialist, Gilead Sciences Inc. Simon Tam, Manufacturing Associate, Revance Therapeutics Kristin Tan, Engineer, Pharmatech Associates, Inc Jose Tavarez, Director, Fourstep Automation, Inc Randall Tedder, Principal, RTR Group Phu Thach, Quality Systems Specialist III, Gilead Sciences Renwick Thompson, Sales, Owens Design Jeffrey Tillack, COO, SafeShot Technologies Inc Jing To, Director of Marketing, Veeva Systems Rodney Tom Caitlin Tretter, Advent Engineering Services Jonathan Tsang, Associate Director API Technology Transfer, Bayer Healthcare Trish Uden, Manager, Fujitsu Janet Wang, Lead PU Engineer, Novartis Pharmaceuticals Nina Wang, Engineer Consultant, PhamaTech Associates, Inc. Theodore Wang, Director of Engineering, Impax Labs Tyler Westcott, Assoc. Dir. of Process Development, Anacor Pharmaceuticals, Inc John Westphal, Principal/Owner, KPW Structural Engineers, Inc. Brian Wheale, Application Specialist II, BioMarin Pharmaceutical Inc. Pawel Wiejata, Sr. CQV Specialist, FW Biokinetics Inc Michael Wilson, Architect, CRB Jon Wolfsen, Manager, Baxter Bioscience Christopher Woo, IMPAX Laboratories Cindy Wu Doug Yamamoto, Sr. Validation Engineer, Delta Project Management Victoria Yan, Sr Project Controls Engineer, Genentech Inc Gloria Ye, QA Validation Engineer, BioMarin Pharmaceutical Inc Gregory Young, Professor & Chair, San Jose State University Jonathan Young, Validation Engineer, Bio-Rad Laboratories ISPE SF Newsletter December, 2014 ISPE SF Board of Directors and Committees President: Simon Forder, Hyde Engineering + Consulting simon.forder@hyde-ec.com (415) 748-8753 Vice President: Karl Wilks, Foster Wheeler USA Karl.Wilks@fwc.com (925) 256-2010 Treasurer: Ralf Elsaesser, Dome Construction ralf@domeconst.com (650) 416-5770 Secretary: Patti Larson, XL Construction plarson@xlconstruction.com (408) 240-6089 Directors: Trevor Auer, CRB Consulting Engineers, trevor.auer@crbusa.com Tareq Barakzoy, ACCO Engineered Systems, tbarakzoy@accoes.com Jason Beck, Alexandria Real Estate Equities, jbeck@are.com Heather Bennett, ACCO Engineered Systems, hbennett@accoes.com Marlene Meza, Grifols, meza_marlene12@sbcglobal.net Ulrike Ruppelt, ticular - Strategies For Success, ulrike.ruppelt@ticular.com Brian Vaughn, CRB, brian.vaughn@crbusa.com Chapter Past Presidents: David Bendet, HDR, 2014 Ian Larson, TRUINJECT 2013 Kelly Keen, Genentech 2012 Corey Veverka, TVS, Inc. 2011 Linda Karr, Genentech 2010 Greg Banks, Banks Integration Group 2009 John Kelley, Genentech 2008 Rob Lynch, Dome Construction Corp. 2007 Mark Hannon, Genentech 2006 Greg Burg, Genentech 2005 Melody Spradlin, Apple 2004 Ed Shea, Currie & Brown 2003 and 2004 Jon Sheh, Johnson & Johnson 2002 Scott Laskey 2001 Haleh Banisadr-Hughes, TVS, Inc. 2000 Jeff Hargroves, ProPharma Group 1999 Sue Cost, Harris Group Inc. 1998 John Sugerik, JTS Enterprises 1997 Dennis Mosher, Bay-Tec (retired) 1996 Ian MacLaren, Southland Industries 1995 Pete McArthur, Amylin (retired) 1994 Burt Van Loon 1993 Program Committee Chair: Jason Beck, Alexandria Real Estate Equities Volunteers: Anthony Bonifacio, PMA Michael Cooper, BioMarin Sue Cost, Harris Group Inc. Leroy Ginn, ACCO Engineered Systems Rick Ginn, XL Construction Wei Huang, Newa Technologies Logan Kelley, BioMarin Jim Redenbarger, BioMarin Nathan Temple, Commissioning Agents Inc. Brian Vaughn, CRB Commuter Conference Committee Chair: Ulrike Ruppelt, ticular - Strategies for Success Volunteers: Ashley Ching, Delta Project Management Jack Commins, Clipper Controls Raffy Espiritu, Impec Group Teresa Johnk, ProPharma Group Harvey Steinhaus, Dome Construction Stacy Stocki, Parker Domnick Hunter ISPE SF Newsletter December, 2014 Young Professionals/Student Affairs Committee Chair: Marlene Meza, Grifols Volunteers: Joel Banks, Banks Integration Cassie Gardner, Banks Integration Meriber Gonzales, Foster Wheeler Peter Graham, Foster Wheeler Jason Montplaisir, Nora Systems Kenneth Ng, Genentech Arne Panzer, Bayer Bill Vandervoot, DST Controls Steve Walker, EORM Marie West, Banks Integration Karl Wilks, Foster Wheeler Faculty: Jim DeKloe, Solano College Claire Komives, San Jose State University Dr. Dorian Liepmann, UC Berkeley Dr. Karen McDonald, UC Davis Community Relations Chair: Heather Bennett, ACCO Engineered Systems Volunteers: Charlie Allnutt, DPR Construction Grace Choi, CRB Jason Everett, SJSU Charity Committee Chair: Ed Shea, Currie & Brown Volunteers: Greg Burg, Genentech Sue Cost, Harris Group Inc. Volunteer Appreciation Committee Chair: Kelly Keen, Genentech Volunteer: Corey Veverka, TVS Vendor Night Committee Chair: Brian Vaughn, CRB Volunteers: Heather Bennett, ACCO Engineered Systems Natasha Masand, Gilead Terrence McCarthy, HDR Science & Technology Kenneth Ng, Genentech Meriber Ramos, Foster Wheeler Biokinetics Cynthia Wiggins, VERSA Engineering/Technology Sokhorn Yim, Genentech Membership Committee Chair: Tareq Barakzoy, ACCO Engineered Systems Volunteers: Mike Britting, D.F. Pray Dave Edgar, Iron Construction Terrence McCarthy, HDR Science & Technology Edda Mihaescu, PhD, Bayer HealthCare LLC Cynthia Wiggins, VERSA Engineering/Technology Fun Day Committee Chairs: Trevor Auer, CRB Volunteers: Arnold Asuncion, Total Validation Services Mike Britting, D.F. Pray Dave Edgar, Iron Construction Claudia Folzman, Iron Construction Edda Mihaescu, PhD, Bayer Healthcare Kevin Norman, DES Architects & Engineers Ravi Shankar, Endress & Hauser Newsletter/Web Site Committee Chair: Sandra Medlin, Sani-Tech West Volunteers: Jane Adams, Quality and Regulatory Compliance Consultants Vamshi Gangupomu, PhD, TVS Inc. ISPE SF Newsletter December, 2014 Advisory Council Chair: Sue Cost, Harris Group Council Members: Jane Adams, Quality and Regulatory Compliance Consultants Carl Albertson, Novartis Pharmaceuticals Mike Batie, Bayer HealthCare Pharmaceuticals Paul Bezy, Genentech Joerg Blaesing, Bayer HealthCare Pharmaceuticals Rob Cone, BioMarin Kay Cowen, Bayer HealthCare Pharmaceuticals Al Dadson, XOMA Al DeGroot, Gilead Sciences Scott Donald, Grifols/Novartis Scott Foell, BioMarin Ross Graves, CRBE Matt Gray, BioMarin Dave Hengel, Genentech David Huff, Genentech Stephen Johnson, SR Johnson Consulting Drew Johnston, Bayer HealthCare Pharmaceuticals Paul Lauer, BioMarin Binh Le, Gilead Sciences Alex Lee, Impax Laboratories Andy Lorenc, Grifols/Novartis Steve Sharon, Genentech Joe Tarantino, Novartis Pharmaceuticals Liaisons (ISPE Past Presidents): Greg Banks, Banks Integration Group, Inc. Greg Burg, Genentech Linda Karr, Genentech Kelly Keen, Genentech John Kelley, Genentech Ian Larson, TRUINJECT Rob Lynch, Dome Construction Corp Corey Veverka, TVS, Inc. Published by ISPE San Francisco/Bay Area Chapter Serving Northern California Newsletter Chair: Sandra Medlin, Sani-Tech West Editor: Kimberly Syre Email: ksyre@cox.net Phone: 946.387.9046 cover photo: Christin Lola @ Fotolia.com #70137005 | ISPE San Francisco/Bay Area Chapter | 5319 University Dr, Suite 641 | Irvine | CA | 92612