ISPE Los Angeles Chapter

Invites you to an Extended Learning Program

Best Practices in Energy Efficient HVAC System Design and Operation

Implementing Energy Savings in a Compliant Environment Alternatives to ACH for Cleanroom Design

Measuring Effectiveness of Ventilation Air Change Rate Reduction

Advanced Control Strategies Top 10 HVAC Misconceptions

Hot Topics - Identify Problem Areas BEFORE They Arise

Wednesday, September 28, 2016

Noon - 6:00 pm

Sponsors: Lundstrom & Associates Architects

Pharma-Bio Serv

Two Host Locations to Choose From: 1. Amgen, One Amgen Center Dr., Thousand Oaks, CA 91320 Note: Check in with security at Building 28 (see map). The meeting will take place in Building 28. 2. Avid Bioservices, Inc., 14262 Franklin Avenue (training room), Tustin, CA 92780 Program Managers: Nick Haycocks, Sr. Specialist, QA, Amgen Paul Crissman, Principal, Biotechnical Solutions Speaker: Norman Goldschmidt, Principal, Vice President, Engineering, Genesis Engineers, Inc. Schedule: 12:00 - 1:00 pm Registration and Networking with Light Lunch 1:00 - 5:15 pm Presentation 5:15 - 5:30 pm Q&A 5:30 - 6:00 pm Networking / Refreshments Synopsis: Ever wonder where those rules of thumb we use for Cleanroom design come from? Curious if there’s another way to approach environmental control than just throwing air (and money) at it? Looking for a scientific way to understand how to maintain cleanliness in classified spaces? Then this is the event for you! Mr. Goldschmidt will discuss the science of cleanroom functions, some of the history, and developing design trends. He’ll review and demystify cGMP regulation and outline practical techniques that you can apply to improve compliance and save energy. Norman will review successful energy saving approaches that have been implemented in approved facilities and suggest methods to garner approval in you company. He’ll also cover topics related to good design, common failures and common citations from regulatory authorities around the world.

Additional Sponsorships Available

ISPE Los Angeles Chapter

Invites you to an Extended Learning Program

Best Practices in Energy Efficient HVAC System Design

and Operation

Wednesday, September 28, 2016 Speaker Bio: Norman Goldschmidt is the Vice President and Principal of Genesis Engineers in Plymouth Meeting, PA. Genesis is a consulting A&E firm, specializing in innovative, energy efficient designs for BioPharmaceutical clients. Norman has over 25 years of experience in conceiving, designing and delivering efficient facilities and processes. Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing - for Pharmaceuticals, Biologics and Medical Devices. Mr. Goldschmidt studied Mechanical Engineering at the University of Buffalo and Engineering Management at the State University of New York. He holds 4 patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) US TAG Delegate and US Expert Delegate to ISO 14644 WG 13 on Energy Efficiency in Cleanrooms and ISO 14644 WG 4 on the Design and Construction of Cleanrooms. Norman provides consulting support to Genesis’ many clients as well as the NIH and NSF. Norman was also the Lead Author of the ISPE Good Practice Guide for HVAC as well as an author of the new ISPE Baseline Guides for Biopharmaceutical Facilities, Oral Solid Dosage Products, Sterile Products, and Laboratories. He is also an Adjunct Professor at the New Jersey Institute of Technology, US instructor for ISPE training class “HVAC and Environmental Control” and trainer for NSF, ISPE, ASHRAE and Regulatory Agencies.

Thank You To Our Chapter Sponsors Platinum

Gold Silver

INSTRUCTIONS ISPE Greater Los Angeles Chapter

Best Practices in Energy Efficient HVAC System Design and Operation Wednesday, September 28, 2016

Registration Fees: ISPE Members - $95

Free for Amgen or Avid Employees (first 15 employees)

ISPE Non-members - $135

Students and Government - $30 (additional Amgen and Avid Employees)

ISPE Young Professional (YP) Member- $50

Event Sponsor - $500 (includes table top and two attendees)

Name badges will be given at the event. For an immediate receipt, please use the Chapter's online processing system. Register Online at: http://atdevents.net/register.php

ISPE LA, SD, SF 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. Please email Rob Fleming (rob.fleming@yahoo.com) for assistance with your username and/or password.

ISPE Members of other Chapters: You will not be in our system unless you have previously set up an account. Please follow instructions for Non Members below. To update your account to a Member account, please forward your confirmation email from ISPE or ISPE Membership Card to Rob Fleming (rob.fleming@yahoo.com). We need your Chapter name, your ISPE Member number and expiration date. You can get your Membership card once logged onto the ISPE website (see bottom left side of the screen).

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.

ALL: 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.

FAX REGISTRATION: Complete the Registration Form with a credit card payment and Fax to (949) 266-8461.

PAY BY CHECK: Register online. Under "Payment Type" select "Company or personal check" or fax your registration form to (949) 266-8461. Then mail your check no later than 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. Tax ID#95-4452996

Cancellations must be received in writing via fax or email to: rob.fleming@yahoo.com by September 21 for refund. After the cancellation date if you have reserved a space but do not attend, your payment MUST be remitted.

For Questions regarding registration or receipts, please contact Rob Fleming: rob.fleming@yahoo.com

REGISTRATION FORM ISPE Greater Los Angeles Chapter

Best Practices in Energy Efficient HVAC System Design and Operation Wednesday, September 28, 2016

Name badges will be given at the event.

________$95 ISPE Members

________$135 NonMembers

________Free for 1st 15 Amgen Employees

________Free for 1st Avid Bioservices Employees

________$30 Students and Government (and additional Amgen or Avid employees)

________$50 ISPE Young Professional (YP) Member s

________$500 Event Sponsor: Sponsors receive a 6' exhibit table and two admissions to the meeting.

If paying by credit card, please check type: ____ VISA ____ MASTERCARD ____ AMERICAN EXPRESS

Name on Card:__________________________________________________________________

Card #:_________________________________________________________________________

Expiration Date:__________ Signature:_______________________________________________

Please cut and paste your contact information here, or fill in the appropriate spaces:

NAME:_____________________________________________________________________________

TITLE:_____________________________________________________________________________

COMPANY:_________________________________________________________________________

E-MAIL: ___________________________________________________________________________

ADDRESS:__________________________________________________________________________

CITY:______________________________________________STATE: ________ZIP:______________

PHONE:__________________________________________FAX:_____________________________

DRIVING DIRECTIONS: Avid Bioservices, Inc. and Perigrine Pharmaceutical 14262 Franklin Avenue (TRAINING ROOM), Tustin, CA 92780 Parking - Please park in the building across the street (see map below). Then walk across to the training room. From I-5 North - Exit at Jamboree Road and turn left. Go under the freeway and turn right on Michelle Drive. Go to Franklin Avenue and turn left. Peregrine is about 1/3 of the way down Franklin on the left side of the street. From I-5 South - Exit at Tustin Ranch Road and turn right. Go to Walnut Avenue and turn left. Go to Franklin Avenue and turn left. Peregrine is about 2/3 of the way down Franklin on the right side of the street. It is recommended that you look up directions from your starting point to make sure you have the best driving directions.

DRIVING DIRECTIONS TO AMGEN 1 Amgen Center Dr. Corner of Amgen Center and Pauling Drive Building 28 Thousand Oaks, CA FOR ALL Once you are parked, walk to Building 28 to check in. NOTE: See attached Amgen Map. Please bring your photo ID with you. It is required for security check in. From San Diego Take 5 Freeway North to 101 (Ventura) Freeway North. Exit at Rancho Conejo Blvd and turn Right (North). Turn Right on Amgen Center Drive Turn Left on Pauling Drive then Turn Left into the Amgen parking lot and park. From Long Beach Take 405 North to US-101 North toward Ventura. Exit at Rancho Conejo Blvd and turn Right (North). Turn Right on Amgen Center Drive Turn Left on Pauling Drive then Turn Left into the Amgen parking lot and park. From Corona Take CA-91 West to I-5 North toward Los Angeles. Take 5 to US-101 North. Exit at Rancho Conejo Blvd and turn Right (North). Turn Right on Amgen Center Drive Turn Left on Pauling Drive then Turn Left into the Amgen parking lot and park. It is recommended that you look up directions from your starting point to make sure you have the best driving directions.