From: Brouwerij West [email protected]
Subject: Grand Opening - This Saturday 12-9pm
Date: February 23, 2016 at 9:45 PMTo: [email protected]
Grand Opening is here this Saturday! View this email in yourbrowser
GRAND OPENING: SATURDAY 12-9pm
ISPE LA Chapter GMP Expo (Vendor Night) Exhibit Show
and Technical Sessions Featuring an FDA Speaker MAY 26, 2016
at Brouwerij West A Newly Opened Brewery in San Pedro
Technical Session #1 3:30 - 4:30 pm
State of the Art Biopharmaceutical Manufacturing in the Developing World
Speaker: John M. Hyde, Chairman and Founder, Hyde Engineering + Consulting, Inc.
Program Manager: Chris Wilkinson, Regional Manager, Southern California, Hyde Engineering + Consulting, Inc.
This Session will Feature Case Studies: New, compliant facilities that minimize capital and operating costs while maximizing manufacturing efficiency
Biopharmaceutical products offer uniquely effective treatments for serious disease conditions. For economic reasons, these drug products have typically only been available to patients in developed countries, but demand is growing in developing countries as their economies expand at relatively rapid rates. This growing demand is being addressed by in-country manufacture of biopharmaceutical products at costs that make treatments accessible to the growing middle classes in the developing world. Biopharmaceutical manufacturing facility case studies will be presented, highlighting strategies and methodologies for minimizing capital cost and construction timelines and maximizing operational efficiency. Cost saving and efficiency maximizing techniques, including the utilization of single-use components, modular construction, islands of automation, flexible and efficient process system configuration, will be discussed.
The session will specifically address: • Design bases for new biopharma manufacturing facilities in the developing world • Strategies and methodologies for minimizing capital cost and construction timelines • Maximization of operational efficiencies for minimization of cost of goods • Role of single use components and modular construction • Automation strategies that maximize operational flexibility while minimizing complexity and costs
About the Speaker: John Hyde founded Hyde Engineering + Consulting in 1993 to serve the Pharmaceutical and Biopharmaceutical community. Prior to the formation of Hyde Engineering + Consulting, John was a Senior Project Engineer with a biopharmaceutical research and manufacturing company located in Boulder, CO. His work included design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm’s large scale and clinical manufacturing facilities. From 1982-1993, John was Manager, Process Systems Design with an engineering firm specializing in the design and start-up of pharmaceutical, dairy and food process systems and the application of CIP technology.
John has published and presented papers at numerous engineering conferences and short courses on topics including biopharmaceutical process systems design, cleaning and cleaning validation principles and practices, FDA compliance strategies, and control systems design for manufacturing processes. John served as a member of the PDA Subcommittee for Biopharmaceutical Cleaning validation and in this capacity he contributed two chapters to “Cleaning and Cleaning Validation, Volume 3”. John serves on the board of the Society of Bioprocess Professionals (SBP) and is a regular speaker at conferences sponsored by SBP, ISPE, PharmaConference, IVT, Microrite and other professional societies. He holds bachelor’s degrees in Food Science and Business Administration and a master’s degree in Food Engineering from Ohio State University.
Thank you To Our Platinum Sponsors
Technical Session #2 5:30 - 7:00 pm
Preparing for an FDA Audit
Speakers: Raymond W. Brullo, DPM, Compliance Officer, Office of Regulatory Affairs, FDA Los Angeles District Vincent J. Cebular, Principal and Senior Vice President of Compliance, Integrated Project Services
Program Managers: Margaret Stava, Sales Rep, GMP Lab Specialists Mehron “Ron” Mirian, Validation Manager, BBraun
Synopsis: The presentation will begin with a presentation by Dr. Raymond Brullo “Preparing for an FDA Inspection: A Compliance Officer’s Perspective. Following will be Vincent Nebular who will focus on how to prepare for a successful PAI (Pre-Approval Inspection) for newly constructed and/or renovated facilities. The approach will follow the FDA’ Six-System Inspection Model with an emphasis on the engineering aspects of Facilities and Equipment Systems and Production Systems. The session will highlight the cGMP requirements throughout a project lifecycle leading up to and supporting a facility inspection. It will include recommendations for interacting with the FDA and planning/conducting Pre-operational Reviews of Manufacturing Facilities (FMD-135). Following a successful plan review, the presentation will progress throughout the project and culminate with the facility inspection / PAI.
About the Speakers:
Dr. Raymond W. Brullo, D.P.M. is a Compliance Officer for the FDA/Office of Regulatory Affairs (ORA) in the Los Angeles District Office. Ray has a B.S. degree in Biology from Loyola University of Chicago. He is a D.P.M., Doctor of Podiatric Medicine from Rosalind Franklin University of Medicine and Science. Ray was previously a Biologics, Bioresearch Monitoring and Medical Device Investigator.
Mr. Cebular is a principal and the Sr. VP of Compliance at Integrated Project Services (IPS). IPS is an industry leader in providing full-service engineering, integrated EPCMV, construction management, project controls, commissioning, validation, and regulatory consulting services to the pharmaceutical, biotech, health care, and specialty manufacturing industries. Vince has over twenty five years of experience in cGMP consulting, engineering, commissioning, and validation of capital projects within the pharmaceutical, biotech, medical gas, and medical device industries. He has a broad range of experience in the areas of bulk drug manufacturing, aseptic processing, solid dosage manufacturing and packaging, vivariums and R&D laboratories. At IPS, Mr. Cebular’s primary responsibilities include leading the day-to-day compliance operations, performing facility audits and design reviews, working with department leaders to promote efficiency and quality work practices, and conducting internal and external training on technology advancement and innovative methodologies.
Thank you to Our Gold Sponsors
Thank you To Our Silver Sponsor
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ISPE LA GMP Expo (Vendor Night) Exhibitors May 26, 2016Company Table Company Table
ABEC 36 Eichleay 28
ACT Environmental Services 37 Ellab, Inc. 47
Advanced Cleanroom Microclean 20 Evoqua Water Technologies 16
Advanced Professional Engineering Consultants Inc 8 Fourstep Automation, Inc. 23
ASTRO PAK 25 FPS 14
Attention to Detail 62 GEMU Valves Inc 73
Azzur Group 52 GF Piping Systems 43
California Electrical Services 6 Grifols 60
Caltrol Inc. 70 Hamilton Company 54
Camfil 58 Holloway America 5
Cannon Building 75 Hyde Engineering + Consulting 21
ChargePoint Technology Inc 46 IPS-Integrated Project Services, LLC 71
Cleanseal Door Systems 59 ISA Los Angeles Section 19
Cockram Construction Inc. 69 JPR Systems 41
Commissioning Agents, Inc. 2 Kinetic Systems, Inc. 35
CRB 40 LabEquipCo 55
DPR Construction 42 Leonard Engineered Products 67
Duhig Stainless 49 Lewa Inc 34
Lives International 76 R2A Architecture 31
M.D. Stainless Services, Inc. 29 ROTRONIC Instrument Corp. 56
Measurement Science Conference 38 Royal Welding & Fabricating 11
Meco 30 Safe-T-Proof Disaster Preparedness Co 15
Millipore Sigma 7 Sani-Matic, Inc. 4
ModWave LLC 48 SEMITORR GROUP 65
Murray Company 64 SGS Life Sciences 1
NeoTech Aqua Solutions 32 Siemens Building Technologies Inc 10
Novatek International 57 Spectrum Labs 33
Pacific Ozone 39 Statco Engineering & Fabricators Inc 27
Pacific Rim Mechanical Contractors 24 Steris Corp Life Sciences 50
Paul Mueller Company 53 Stilmas SpA 22
Pharma-Bio Serv 72 StoneL 51
Piercan USA, Inc. 63 Technical Safety Services 3
Ponton Industries, Inc. 13 Trinity Process Solutions Inc 66
ProcessHQ, Inc. 74 Vanrx Pharmasystems, Inc. 18
ProSys 45 WaterSaver Faucet Co. 61
PSC Biotech 26 WIKA Instrument, LP 44
Purity Systems Inc 68 Xyntek, Inc. 17
BY SARAH BENNETT
Brouwerij West’s New San PedroSpace Is Amazing. So Are Its Beers
FRIDAY, FEBRUARY 26, 2016 AT 8:42 A.M.
Opening-day lineup
Sarah Bennett
Brouwerij West’s expansive San Pedro facility, housed inside a70-year-old Port of Los Angeles receiving warehouse a few hundredfeet from the water, officially opens Saturday after nearly threeyears of construction.
Brouwerij West’s New San Pedro Space Is Amazing and So... http://www.laweekly.com/restaurants/brouwerij-west-s-new-s...
Awash with exposed wood, the historic building is an open-air marvel that providesvisitors with views of the surrounding palm trees and blue skies and lets the sea breezewaft through owner Brian Mercer’s modestly sized brewhouse, which he says uses 30percent less water than a normal brewery and runs entirely off of power generated bysolar panels installed on the roof.
“It’s like a big tent in here,” Mercer says, under the glow of the tasting room’s soft-whiteChristmas string lights. “It suits us with our mixed fermentation.”
While much attention has been paid to Brouwerij West’s breathtaking space, even moreexciting are the mixed-fermentation beers Mercer is now making inside of it.
Tasting room inside the 72-year-old building
Facebook/Brouwerij West
Mixed fermentation is how funky or sour beers are made – by “mixing” multiplemicroorganisms such as Brettanomyces (a yeast) or Lactobacillus (a bacteria) into an
otherwise “clean” brew. In American and British-style beers, mixed fermentation is rare,but in Belgium, where Mercer has been traveling for much of the last 10 years as part ofhis candy-sugar importing business, creating highly nuanced beers through this processis common.
Brouwerij West’s New San Pedro Space Is Amazing and So... http://www.laweekly.com/restaurants/brouwerij-west-s-new-s...
Sponsor Content
Since 2010, Mercer has been gypsy-brewing his own Belgian-inspired ales at differentbreweries, from Bayhawk in Irvine to Hermitage in San Jose, and selling bottles and kegsof regular-fermentation beers such as his blonde, tripel and quadrupel across the state.He says that working within another brewery’s scheduling confines made it nearlyimpossible to experiment beyond the standards; a mixed-fermentation beer often needsto sit around until it develops the ideal flavors.
“When I was a contract brewery, we had a strict two-week turnaround,” Mercer says.“There’s only so much you can do in that time.” The San Pedro brewery is a chance forMercer to finally try something different. In addition to having a state-of-the-artbrewhouse where he can brew on his own time, Mercer utilizes a mash filter instead of alauter tun during the brewing process. That not only helps achieve more efficiency inextracting sugars from the malt but also allows Brouwerij West to make mixed-fermentation beers with grains that are ordinarily off-limits to other breweries.
Of the seven first-batch beers that will be on draft this weekend, three of them – a SourOrange Wit (a 100 percent wheat beer), an extra orange-y version of the Sour Orange Witand a spelt saison – were made possible by this mash filter. Mercer also is currentlyfermenting another odd-grain beer, made with 55 percent buckwheat.
“This brewery gives us the ability to do all sorts of weird things,” Mercer says.
Though you can find familiar Brouwerij West beers like the tripel and blackberry saisonon the opening-day tap list, Mercer doesn’t plan on having any core beers for now; hesays he’s just excited to be chasing new recipes and seeing when they’re ready.
Don't expect an IPA anytime soon.
"I don't even know how to make an IPA. We’re like a Japanese restaurant,” he says. “Wedon’t have burritos. We’re doing something different, and we hope people like it.”
Brouwerij West's grand opening is Saturday, Feb. 27, noon to 9 p.m. (it's free!), and features food
trucks and performances by San Pedro bands. 110 E. 22nd St., Warehouse No. 9, San Pedro; (310)
833-9330, brouwerijwest.com.
Brouwerij West’s New San Pedro Space Is Amazing and So... http://www.laweekly.com/restaurants/brouwerij-west-s-new-s...
Schedule 12:30 - 2:30 pm Exhibitor Set Up
2:30 - 3:30 pm Networking in Exhibit Area
3:30 - 4:30 pm Technical Session State of the Art Biopharmaceutical Manufacturing in the Developing World
4:30 - 5:30 pm Break in Exhibit Area
5:30 - 7:00 pm Technical Session Preparing for an FDA Audit
6:30 - 8:00 pm Happy Hour Exhibit Show & Student Poster Contest with Appetizers
Registration Instructions To Register and Receive an immediate receipt, use our on-line registration: http://atdevents.net/register.php
ISPE Members: If you are an ISPE Member in California, please do not set up a new account as you should already be in our system.
Non Members and Members of Other Chapters: If you do not have an account on our system, you can set one up on the site using letters (not numbers) as your username.
Registration Assistance: If you need help setting up your account or if you are having problems with the site or need a new password, please email Rob Fleming ([email protected]) for assistance.
All badges will be at the event for pick up.
Registrations can be faxed using this form with credit card payment to 949-266-8461.
Phone Call: If you cannot log on or are too busy to register online, call 949-387-9046 with your credit card payment. Our office is not always staffed, feel free to leave a message with your credit card information and email address. It will be processed and a receipt will be sent.
Checks should be made payable to: ISPE Greater Los Angeles Chapter, 5319 University Dr., Suite 641, Irvine, CA 92612. ISPE LA Federal Tax ID #95-4452996. Tel: 949-387-9046
Cancellations: Send an email to: [email protected] by May 1, 2016 for refund. No smoking on premises.
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REGISTRATION FORM ISPE Greater LA Chapter
GMP Expo (Vendor Night) Exhibit Show May 26, 2016
Brouwerij West 110 West 22nd Street, Warehouse 9, San Pedro, CA 90731
Attend Technical Sessions and Visit the Table Tops ___ $20 For All Industry Professionals - Includes parking, 1 drink ticket and appetizers
Exhibitor Table Top Cost ___ $805 Includes Two Attendees, 1 Drink Ticket Per Person, Table Cover and Electricity ___ $75 Purchase Package of 10 Attendee Tickets to give to Employees and Customers
Sponsors ___ $500 if Sponsoring but Not Exhibiting ___ $250 for Existing Exhibitors Please indicate: ____Beer Sponsor ____Dinner Sponsor ____Sweets Sponsor Includes Two Attendees, 1 Drink Ticket Per Person and a Sign at the Event
Additional Exhibitor Attendees ___ $20 For Each (includes parking, 1 drink ticket, appetizers and technical sessions) Exhibitors: Please bring door prizes to give away during the event. Prizes will be announced, winners will be sent to your table to claim their prize.
List your Top 10 Table Choices:
Note: Tables will be given in the order paid All exhibit 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).
First/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:
Brouwerij West 110 West 22nd Street, Warehouse 9 Next to Crafted LA San Pedro, CA 90731 Lots of Free Parking
DRIVING DIRECTIONS From Los Angeles International Airport (LAX) Take 405 Freeway South to 110 Freeway South. Take Exit 1A for CA-47 toward Vincent Thomas Bridge/Terminal Island/Long Beach. Take Harbor Blvd. Exit. Turn Right onto N. Harbor Blvd. Harbor turns into Miner St. Continue onto Miner St. Turn Right onto E. 22nd St. Turn Right into parking lot for Crafted LA and Brouwerij West.
From San Diego Take 5 Freeway North to 405 Freeway North to 110 Freeway South. Take Exit 1A for CA-47 toward Vincent Thomas Bridge/Terminal Island/Long Beach. Take Harbor Blvd. Exit. Turn Right onto N. Harbor Blvd. Harbor turns into Miner St. Continue onto Miner St. Turn Right onto E. 22nd St. Turn Right into parking lot for Crafted LA and Brouwerij West.
It is recommended that you look up driving directions from your own starting point using GPS.
Driving Directions
List of All Who Will Be Attending: Note: 2 attendees are included with your table payment, $20 per attendee for each additional attendee Please make sure to email an Excel list of your company employees and customers who will be at the vendor table top along with payment if you have not already paid online, so we can prepare name badges for them (first name, last name, company and email address for each person),. Email to: [email protected]
Set Up Time: 12:30 - 2:00 pm
Table Size: 6 feet long by 21/2 feet wide
These are table tops only, not exhibit booths. We have found that since these are small table tops, many vendors stand in front of their tables eliminating a barrier between you and your potential clients. Each table will be covered, however, you are welcome to bring your own table cover. Your entire display must fit on your table with no items on the floor. Please see the next page which are guidelines established by ISPE explain-ing the maximum size of displays. Chairs will be available for those needing them.
Electricity: Each table will receive one outlet. If more outlets are needed, please bring a power strip and extension cord.
Payment: If you have not sent in your payment for your table top, please do so as soon as possible. We must receive your payment by May 1, 2016. TABLE TOP PAYMENTS WILL NOT BE ACCEPTED AT THE DOOR.
Deadlines May 12, 2016 ListofYourCompany’sAttendees May 12, 2016 Table Payment Due
Pass The Word: This is your show. Please tell everyone in the industry about our event. We are competing with many other shows and to continue our success, we need your help. Please forward the event email to people you are in contact with at local biotech, pharmaceutical, medical device and related industry firms.
General Information for Exhibitors
ISPE ExhibitorGuidelines
The following restrictions for table tops are set by ISPE Headquarters:
1) Exhibits must be staffed at all times during exhibit hours. Exhibitors may not take down display before closing hours.
2) Exhibits must conform to the following:
• The entire display must be confined to the top of the table only (nothing will be allowed to hang off, behind, or along side of the table).
• Themaximumheightofanydisplayshallbe60”abovethetabletopincluding lights, signs, etc. However, taller roll up displays will also be allowed on the table or on the floor butted up against the back of the table (looking as if it is part of the table).
• Themaximumwidthofanydisplayshallbe72”.Displaysmustnotoverhang top of the table.
• Onlystaticdisplaysareacceptable.Nooperatingmachineryofanytypewill be allowed, however, computers are acceptable.
3) ISPE reserves the right to restrict table top exhibits which are objectionable because of size, noise, glaring or flashing lights, method of operation, or any reason and, therefore, to prohibit or evict any exhibitor who, in the opinion of ISPE, may detract from the overall good of the exhibit. This reservation includes person, conduct, printed matter or anything ISPE judges to be objectionable.
4) Anyfailuretocomplywiththeaboverestrictionsmayresultinexclusionfromparticipationin future ISPE table top events.
NOTE: If your company’s display does not conform to the guidelines listed above, table top displays can be rented by the day. You can find display companies by looking up “Display” in the yellow pages.
Venue Information: Brouwerij West
110 West 22nd Street, Warehouse 9San Pedro, CA 90731
Shipping Information:There is no shipping to or from the venue. All display materials need to be brought with you to the venue and taken by you at the end of the event.
Area Hotels:We do not have a room block for sleeping rooms. Here is a list of San Pedro hotels:DoubleTreeSanPedro-PortofLosAngeles(nicehotelinthemarinaveryclosetothevenue)Best Western Plus San Pedro Hotel & Suites (have not stayed there, on busy street, but photos on line look nice)
Downtown Long Beach hotels (about 10 miles away):Hyatt Regency Long Beach, Hilton Long Beach, Hyatt Centric The Pike Long Beach, Renaissance Long Beach, Hotel Maya - DoubleTree, Westin Long Beach
Food and Beverage: Nofoodorbeverageofanykindshallbepermittedtobebroughtintothepremises.Exhibitorscanhandoutcandyattheir table, but not food or drinks. Please contact the hotel for any food or bevarage needs for your exhibit table.
Damages: The exhibitor(s) will be financially responsible for repair of any damage to walls, floors, permanent fixtures or furnishings.
Garbage and Trash Removal: Pleaseremoveallmaterialsandemptycartonsfromyourexhibitareauponconclusionoftheevent.Allmaterialsshouldberemovedfromexhibitareaswhenunattended.NeitherISPEnorthehotelareresponsibleforlost,damagedorstolenarticles.
Signage: ItemsmayNOTbeaffixedtowallswithnails,pushpins,tape,staples,orbyanyothermeans.
Smoking: This is a non smoking event.
ISPE Greater Los Angeles Chapter
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