Exhibit Show Free to Attend 3:30 - 8:00 pm Exhibit Tables Available $725 Regular Table / $795 Premium Table No Cost to Visit Exhibits or Attend Technical Sessions

ISPE  Los  Angeles  Chapter’s  22nd  Annual  GMP  Expo  (Vendor  Night)  Exhibit  Show         with  Complimentary  Technical  Seminars  

Renaissance  Long  Beach  Hotel  111  E.  Ocean  Blvd.,  Long  Beach,  CA  90802  

We  hope  you  can  join  us  at  this  fun  annual  event.  It’s  a  great  Tme  to  network,  to  meet  new  industry  associates  and  catch  up  with  friends.  This  year’s  theme:  “Hollywood  Red  Carpet”  at  the  Renaissance  Long  Beach  Hotel.          It’s  free  to  aYend  the  technical  seminars  and  enjoy  networking  with  the  exhibitors  and  other  industry  professionals.  Complimentary  appeTzers  will  be  served.  

Register  Online:  hYp://atdevents.net/register.php

GMP EXPO VENDOR NIGHT

AND TECHNOLOGY SUMMIT

MAY 14, 2015

Exhibit Show and Technical Sessions

http://atdevents.net/register.phphttp://atdevents.net/register.php

Technical Session #1 - Water for Pharmaceutical Systems (2:30 - 4:30 pm) Free to Attend Thank you to our exhibitors for sponsoring these complimentary technical sessions. As an attendee, your only responsibility is to network with the exhibitors, thanking them for allowing us to provide these sessions free of charge. And, be sure to bring lots of business cards.

Program Managers: Justin Cantor, Director, PSC Biotech and Nick Haycocks, Sr. QA Specialist, Amgen Inc.

Speakers: Nissan Cohen, Business Development Manager, Rohrback Cosasco Systems, Inc. J.P. Jiang, Chief Technical Officer, Instant BioScan, Inc.

Part 1: Chemical-Free Pretreatment: How to eliminate GACs, Metabisulfate dosing, Softeners, and their expensive maintenance and water wastage from your Pharmaceutical Water System. This is a Hot topic for California after Governor Brown's edict on April 1. Speaker: Nissan Cohen, Business Development Manager, Rohrback Cosasco Systems, Inc.

Part 2: This presentation describes an optical spectroscopy based real time waterborne microbial detector for pharmaceutical water systems. Application examples of RMS in process verification and process control monitoring of a purified water system will be presented.

The speaker hopes that the attendees will get a technical understanding of a new method for real time microbial monitoring in water, some suggestions in how to use such method in water purification process and application examples for helping in implementing such a method in their facilities. Speaker: J.P. Jiang, Chief Technical Officer, Instant BioScan, Inc.

Part 3: Rapid Microbial Monitoring: Integration and Implementation of an RMS, regardless of detection methodology, for Pharmaceutical Water Systems Speaker: Nissan Cohen, Business Development Manager, Rohrback Cosasco Systems, Inc.

Part 4: There will be a Q&A session to allow the audience to ask the presenters questions. About Nissan Cohen: A worldwide expert, with 40 years experience, in Total Organic Carbon (TOC), high purity, ultrapure, reclaim and recycle water systems, with profound expertise in instrumentation, automation, and organic contamination oxidation systems using ozone, UV, ion exchange and catalysts. Accomplished writer of over 35 technical articles published in Ultrapure Water, A2C2, Pharmaceutical Technology, Pharmaceutical Engineering, Semiconductor International, The Journal of the Institute of Environmental Sciences and Technology. Four times nominated and recipient of Pharmaceutical Engineering’s “Article of the Year” award given to a single article out of over 100 published articles for any given year. Contributing author and Chapter Leader of “Baseline Guide for Pharmaceutical Water and Steam Systems”. Co-chairman and Coordinating Author of the “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems” Good Practice Guide, Contributing author to the Good Practice Guide on Ozone, member of ISPE (International Society for Pharmaceutical Engineering), Technical Editor of the Journal of the Institute of Environmental and Science Technology (IEST), Technical Reviewer of Pharmaceutical Engineering, Chairman of the Water and Steam Forum of ISPE, Founder/Chair of the Discussion Forums of ISPE, Former member of the Technical Advisory Board of A2C2 magazine. Education: University of Wisconsin and Ruppin Institute – degree in Agriculture and Genetics. Bilingual in English and Hebrew. Working knowledge of five additional languages. Member of International Standards Committees: ASTM E-55, IEST (WG 14644 Contamination Control), ASTM D-19.03, ISPE (International Society for Pharmaceutical Engineering) Steering Committee member for Communities of Practice Standards: Critical Utilities.

Former Chairman of ISPE Committees: Membership Services, Publications, Pharmaceutical Engineering and Website. Former Steering Committee member of COPs: HVAC and PAT.

About J.P. Jiang: Jiang obtained his Ph.D. in Physics at the University of Southern California, with his thesis focused on: “Four wave mixing in photorefractive and polymeric materials: ring phase conjugator and time-resolved measurement of third order optical nonlinearity” in 1990. His M.S. in Physics was acquired at Polytechnic Institute of New York, and B.S. in Physics at Peking University, China.

Jiang served as a Postdoctoral Fellow at the University of Arizona Optical Science Center. He also developed an allergen detector for Sunbeam Corporation, and was the lead inventor for the development and manufacture of a laser diode based bio-particle detector at Bio Vigilant Systems, Inc. Currently he has patents pending for the laser diode based bio-particle detector for water at Instant BioScan. He has numerous scientific publications in the field of optics, has presented at national and international scientific conferences and is also a member of the Optical Society of America.

Technical Session #2 (2:30 - 4:00 pm) Free to Attend Thank you to our exhibitors for sponsoring these complimentary technical sessions. As an attendee, your only responsibility is to network with the exhibitors, thanking them for allowing us to provide these sessions free of charge. And, be sure to bring lots of business cards.

2:00 - 2:30 pm Seminar Registration 2:30 - 4:00 pm Two Concurrent Seminars

Session #2 New Regulatory Guidances on the Prevention of Potential Cross-Contamination in Multi-Purpose Pharmaceutical Manufacturing Facilities and To Minimize DNA-reactive Impurities

Speaker: Alan W. Ader, Ph.D., DABT, Vice President, SafeBridge Consultants, Inc.

Program Manager: Paul Crissman, Principal, Biotechnical Solutions

Abstract: The increasing focus of regulatory authorities (US FDA, EMA, MHRA and Health Canada) is on product quality, to ensure that the drugs being given to patients are safe and effective, and are not contaminated by impurities or the product being made on shared equipment.

Recently regulatory action has taken place in Europe to obligate drug manufacturers to determine Permissible Daily Exposure (PDE) values that represent the amount of a residual chemical substance in a drug product that are considered safe for all populations. Previously ISPE had issued in their Baseline® Guide known as Risk-MaPP, the determination of Acceptable Daily Exposure (ADE) values by a similar quantitative health-based risk assessment approach. In both cases, the ADE/PDE is used to develop cleaning limits that would be acceptable and prevent product cross-contamination. Furthermore, changes have been made to European cGMP regulations (Chapter 5) that describes that as part of a Quality Risk Management approach that a potency and toxicological evaluation be made of the drugs to prevent product cross-contamination.

Additionally, on a related front, the ICH M7 DNA-reactive impurities guidelines have also been instituted which obligates drug manufacturers to assess whether materials added to their products or are process related impurities or intermediates are mutagenic / DNA-reactive.

The practical implications of these new guidances will be discussed with example cases described including building these elements into a quality risk management approach to pharmaceutical manufacturing.

About Dr. Alan Ader Dr. Allan Ader has over 20 years experience in toxicology, risk assessment and industrial hygiene. He has an extensive background in evaluating complex environmental, health and safety issues and in developing solutions and programs. Dr. Ader has experience in: • Developing Occupational Exposure Limits and assessing compounds for toxicity and potency for compound categorization / banding and recommending handling practices and controls based on the toxicity/potency characteristics;

• Assisting companies in testing of chemicals for their toxic effects and interpreting data from these tests • Performing risk assessments including evaluating toxicological and exposure information to determine potential health effects of chemicals • Responding to crises caused by occupational health illnesses from chemicals by assessing and evaluating risks and communicating them to employees and management

His pharmaceutical and chemical industry experience includes working for Syntex, Inc. in Palo Alto, CA and Olin Corporation, New Haven, CT. He received a Ph.D. in Industrial Health (Toxicology) from the University of Michigan and an M.S. in Industrial Hygiene from Temple University. He is a Diplomate of the American Board of Toxicology.

Technical Session #3 (5:30 - 6:30 pm) Free to Attend Thank you to our exhibitors for sponsoring these complimentary technical sessions. As an attendee, your only responsibility is to network with the exhibitors, thanking them for allowing us to provide these sessions free of charge. And, be sure to bring lots of business cards.

Session #3 PAT: An Automated Bioreactor Sampling Solution for Assuring On-line PAT Analytical Fidelity

Speaker: Michael Biksacky, President, Flownamics, Inc.

Program Manager: Scott Tiedge, Managing Director, Flotek

Abstract: In the current bioprocessing environment a significant unmet need still exists for precise, automated, real-time analysis of important culture process parameters such as nutrients, metabolites and various cell measurements. Transforming these traditional off-line analytical methods into an effective, automated, on-line process analytical technology (PAT) platform requires certain criteria to be met.

At a minimum, an automated sampling system should (1) not compromise the bioreactor’s sterile environment; (2) establish connectivity of process systems; (3) facilitate a scale-independent strategy; (4) seamlessly integrate the real-time data into the process management system and (5) provide rapid and precise analysis that performs as good as or better than the manual off-line analytical method.

A (blank) automated on-line sampling system, which meets the aforementioned criteria, was evaluated for its ability to preserve the analytical integrity of various integrated 3rd party analyzers typically used for culture process monitoring. The performance evaluation encompassed a broad range of analytes and measurement ranges, while comparing automated on-line analysis with the analyzer’s respective manual, off-line analytical method. In short, the analytical fidelity of each (blank) integrated analyzer was preserved and demonstrated a reliable, automated on-line PAT solution for bioreactor culture monitoring and control.

About Michael Biksacky Michael Bikasky is the founder and President of Flownamics, Inc. The company designs high quality products to assist researchers in developing methods to optimize their fermentation or bioreactor process.

He is a graduate of University of Wisconsin at Madison in Chemical Engineering.

Schedule 1:30 - 3:30 pm Exhibitor Set Up

2:00 - 2:30 pm Technical Seminar Registration

2:30 - 4:00 pm Cross Contamination Seminar

2:30 - 4:30 pm Water Seminar

3:30 - 8:00 pm Exhibit Show Hours

5:30 - 6:30 pm PAT Seminar

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. Your ISPE Member number is your username.

Non Members: 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 (rob.fleming@yahoo.com) for assistance.

Note: For those walking the show or attending the technical seminars (Free attendance), you can also email Rob Fleming (rob.fleming@yahoo.com) asking to be added to the list.

All badges will be at the event for pick up.

Registrations can also be faxed using this form with credit card payment 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. Tel: 949-387-9046

Cancellations: Send an email to: rob.fleming@yahoo.com by May 1, 2015 for refund.

REGISTRATION FORM ISPE Greater Los Angeles Chapter

GMP Expo (Vendor Night) Exhibit Show & Technology Summit

May 14, 2015

Renaissance Long Beach Hotel 111 E. Ocean Blvd., Long Beach, CA 90802

(562) 437-5900

Visit the Table Tops ___ Free For All Industry Professionals Attend Technical Sessions (Please Note: Sessions are Concurrent, Select One) ___ #1 - Water for Pharmaceutical Systems ___ #2 - Regulatory Guidance on the Prevention of Potential Cross Contamination in Pharmaceutical Manufacturing Facilities ___ #3 - PAT: An Automated Bioreactor Sampling Solution for Assuring On-line PAT Analytical Fidelity Exhibitor Table Top Cost - All Tables Receive Table Cover and Electricity ___ $725 (R) Regular Table - White Tables on Diagram ___ $795 (PR) Premium Table - Yellow Tables on Diagram

List your Top 10 Table Choices: Note: 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:

http://atdevents.net/register.phpmailto:rob.fleming@yahoo.commailto:rob.fleming@yahoo.comhttp://atdevents.net/register.phpmailto:rob.fleming@yahoo.commailto:rob.fleming@yahoo.com

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22nd Annual G

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If Registering O

nline, Please use pull down box to select your table

when registering. If registering via fax, please List Your Top 9 Table

Choices in order of preference and Fax to: 949-266-8461

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2._____________ 3._____________ 4._____________ 5._____________

6._____________ 7._____________

8._____________ 9._____________

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Registration Tables

Entrance Entrance

Food Station

Food Station

Food Station

PR23

PR32 PR33 PR39

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PR31 PR34 PR35

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PR11

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PR1 PR2 PR3 PR4 PR5

PR13PR16 PR14PR15

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EntranceEntrance

Technical Sessions

GE

Analytical

Instruments

AzzurGroup

Com

missioning

Agents, Inc.

AtlantiumTechnologies

Ellab

Sani-M

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Sem

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Flownam

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Em

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Beckm

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Purity

System

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LifeS

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Rohrback

Cosasco S

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IPS

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ISPE  LA  Chapter  Vendor  Night  -‐  May  14,  2015

 CompanyAstro  Pak PR 31

Atlantium  Technologies PR 17

Azzur  Group PR 30

Bausch  +  Stroebel  Machine  Co  Inc PR 2

Beckman  Coulter R 30

BioTek  Systems/Process  HQ PR 32

California  Electrical  Services R 15

Caltrol,  Inc. R 32

Camfil PR 14

Cannon  Building PR 11

ChargePoint  Technology  Inc. R 25

Cleanseal  Door  Systems  -‐  ASI  Technologies PR 36

Cockram  Construction,  Inc. PR 38

Cold  Box  Express PR 1

Commissioning  Agents,  Inc PR 29

Cornerstone  Flooring PR 20

CRB PR 34

DPR  Construction PR 39

Duhig  Stainless PR 23

Eichleay PR 12

Ellab,  Inc. PR 28

Emerson  Process  Management-‐Rosemount R 31

Evoqua  Water  Technologies PR 3

Flownamics,  Inc. R 34

Foamtec  International PR 5

GE  Analytical  Instruments R 35

GEMU  Valves  Inc PR 22

Hamilton  Company PR 18

Table  NumberExhibitor  List

Hyde  Engineering  +  Consulting PR 16

IPS R 14

ISA R 6

ISEC PR 35

Kinetic  Systems,  Inc. PR 37

Laboratory  Equipment/Unbound  Consulting R 10

LEWA,  Inc. PR 19

Lives  International R 38

M.D.  Stainless  Services,  Inc. R 9

Measurement  Science  Conference R 17

Murray  Company PR 4

Pacific  Rim  Mechanical PR 24

ProSys R 29

PSC  Biotech R 1

Puretec  Industrial  Water R 20

Purity  Systems  Inc. R 24

Quattroflow/PHQ R 28

R2A  Architecture R 11

Reliance  Safety  Consultants PR 9

Rescop,  Inc. PR 26

Rohrback  Cosasco  Systems R 19

Royal  Welding  &  Fabricating/ARS R 4

RPA R 2

Sani-‐Matic PR 27

Semitorr  Group PR 25

SGS  Life  Science  Services R 21

Statco  Engineering  &  Fabricators  Inc PR 10

Technical  Safety  Services PR 33

Trinity  Process  Solutions PR 13

Turner  Construction PR 15

Vaisala  Inc R 12

Validation  Technologies,  Inc. PR 21

Renaissance Long Beach Hotel 111 E. Ocean Blvd., Long Beach, CA 90802 Parking: $12 Flat Fee

Parking and Access to Ballroom Pull into parking garage. Take the elevator to the lobby then cross the lobby to the internal elevator bank. Take elevator to 2nd floor to the Renaissance Ballroom. If the lot is full, there are plenty of City of Long Beach parking lots on Pine Street. To find City parking lots, head out of the hotel and turn right on Pine Street. Watch for signs.

DRIVING DIRECTIONS From Los Angeles International Airport (LAX) - 21 Miles Take 405 Freeway South to 710 Freeway South. Exit at Downtown Long Beach/Convention Center/Aquarium. Merge onto Shoreline Dr. W. Turn Left onto S. Pine Ave. Turn Right onto E. Ocean Blvd. Make a U-Turn at S. Locust Ave to head West on Ocean Blvd. The venue will be on the Right Hand Side.

From Irvine - 24 Miles Take 405 Freeway North to 710 Freeway South. Exit at Downtown Long Beach/Convention Center/Aquarium. Merge onto Shoreline Dr. W. Turn Left onto S. Pine Ave. Turn Right onto E. Ocean Blvd. Make a U-Turn at S. Locust Ave to head West on Ocean Blvd. The venue will be on the Right Hand Side. Pull into parking garage. Take the elevator to the lobby then cross the lobby to the internal elevator bank. Take elevator to 2nd floor - Renaissance Ballroom.

From All Areas Take the closest freeway, navigate to 710 Freeway South. Exit at Downtown Long Beach/Convention Center/Aquarium. Merge onto Shoreline Dr. W. Turn Left onto S. Pine Ave. Turn Right onto E. Ocean Blvd. Make a U-Turn at S. Locust Ave to head West on Ocean Blvd. The venue will be on the Right Hand Side.

It is recommended that you look up driving directions from your own starting point.

Driving Directions

List of All Who Will Be Attending: Please make sure to email a list of your company employees who will be at the vendor table top, so we can

prepare name badges for them. Email to: rob.fleming@yahoo.com

Set Up Time: 1:30 - 3:30 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 an extension cord and power strip.

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, 2015. TABLE TOP PAYMENTS WILL NOT BE ACCEPTED AT THE DOOR.

Deadlines May 1, 2015 ListofYourCompany’sAttendees May 1, 2015 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: Renaissance Long Beach Hotel

111 E. Ocean Blvd., Long Beach, CA 90802

Shipping Information:Pack With Your Display: Completed Shipping Forms for Return Shipments

Advance Freight: Due to very limited storage space at the venue, it is requested that you plan to bring all materials with you the day of the

event. If that is not possible, please ship your materials (no more than two days prior to the event). Packages should be

shipped directly to Renaissance Long Beach Hotel at the address above. CLEARLY label all parcels with the following information: HOLD FOR ARRIVAL: ISPE, May 14; [Your Name]; [Company]

Outbound Shipping: TO AVOID ANY PROBLEMS RECEIVING YOUR DISPLAY AFTER THE SHOW, PLEASE READ.Your company reps should pack completed shipping forms with account number and return address (i.e. Federal

Express,UPS,AirborneExpress)withyourdisplaypriortosendingittothehotel.Thiswayallyouhavetodoistakethe document and affix it to your display after the show and you are on your way. We also suggest that you contact your

carrier to arrange for pick up the day after the show.

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.

ISPE Greater Los Angeles Chapter