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ISPE Greater Los Angeles Chapter
Invites you to
Improving Robustness and Streamlining Project Delivery
Through Science and Risk-Based Commissioning and Qualification
Learn about Applying ASTM E2500
October 23, 2014
5:00 - 8:30 pm
Program Managers:
Paul Crissman, Biotechnical Solutions
Dona Tseng, Sr. Principal Engineer, Baxter Healthcare
Location:
Baxter Healthcare
4501 Colorado Blvd.
Building 6
Los Angeles, CA 90039
Speakers:
Phil Bowles, Director Engineering, Amgen Inc.
Robert Chew, President, Commissioning Agents Inc.
Rick Kramer, President, CPFS
Cost:
$50 ISPE Members
$85 Non-members
$30 Students/Government
$30 Young Professionals
$500 Event Sponsor (includes table top and 2 admissions)
Free for Baxter Employees
Registration Deadline: October 17, 2014
Registration is limited. Register early to ensure your spot!
Bring your photo ID for Baxter security.
Improving Robustness and Streamlining Project Delivery
Through Science and Risk-Based Commissioning and Qualification
Learn about Applying ASTM E2500
October 23, 2014
Schedule
5:00 - 6:00 pm
Registration with light dinner
6:00 - 6:15 pm
Welcome from Chester Zelaya, Baxter Plant Manager
6:15 - 6:50 pm Journey towards a fully mature risk-based approach for commissioning and
qualification of equipment and facilities
Speaker: Phil Bowles, Director Engineering, Amgen Inc
Implementing a risk-based approach to commissioning and qualification based on ASTM E2500
offers significant advantages to manufacturing companies which are demonstrated through a
case study for recent large biopharmaceutical capital projects. Delivering these benefits also
requires a range of technical, quality and organizational challenges to be overcome, particularly in
how to apply the guiding principles from the E2500 standard guide. Some of these challenges are
addressed along with discussion of “where next” on our journey towards a fully mature risk-based
approach for commissioning and qualification of equipment and facilities.
6:50 - 7:25 pm Verification, SME Leveraging & Life Cycle Data Harvest:
The Project Information Supply Chain’s key role in the path to ASTM E2500 implementation
Speaker: Rick Kramer, President, CPFS
Life Science manufacturing companies are advancing their ability to fully realize the benefits of
ASTM E2500. To do so, requires the next evolution of cultural acceptance, as well as innovative
tools and methodology. Qualifying the OEM vendor supply base to participate as
SME’s enhances overall GEP and realizes cost benefits and project execution efficiency. A front
loaded approach to aligning the Risk Based C&Q strategy with the Project Information Supply
Chain allows the intelligent harvest & dissemination of critical Qualification Information, and key
Life Cycle Data in support of owner Compliance and OpEx.
7:25 - 8:00 pm Steps Along the Way: Best Practices and Pitfalls to Avoid in E2500 Implementation
Speaker: Robert Chew, President, Commissioning Agents Inc.
The pharmaceutical industry is still sorting out best practices for implementing an ASTM E2500based approach to commissioning and qualification. Through our work with numerous customers,
we have seen some approaches that have worked well, and other approaches that resulted in a
variety of unforeseen obstacles to overcome; we will discuss examples of both. In addition, some
of the special challenges of implementing a risk-based approach for companies that already have
a mature traditional commissioning and qualification program in place will be covered. Finally, we
will discuss some of the tools that have proven to be useful on a variety of projects.
8:00 - 8:30 pm Q&A - All speakers and Ronald Brunelle, Amgen Corporate Quality
9:00 pm
Parking lot closes
ISPE Greater Los Angeles Chapter
Improving Robustness and Streamlining Project Delivery
Through Science and Risk-Based Commissioning and Qualification
Learn about Applying ASTM E2500
October 23, 2014
REGISTRATION FORM and INSTRUCTIONS
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 Members: If you are an ISPE Member in CA, please do not set up a new account. You should already be in our
system. Please email Rob Fleming ([email protected]) for assistance with your username and/or password. If
you are a Member of another Chapter, please fax your registration with your Member number and Chapter affiliation.
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 ([email protected]) 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:[email protected] by October 17, 2014 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: [email protected]
Name badges will be given at the event. ________$50 ISPE Members ________Free for Baxter Employees
________$85 NonMembers ________$30 Students and Government
________$500 Event Sponsor ________$50 ISPE Young Professional (YP) Member
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:_____________________________________Signature:___________________________________
Card #:________________________________________________________________Expiration
Date:__________ Please cut and paste your contact information here, or fill in the appropriate spaces:
NAME/TITLE:_____________________________________________________________________________
COMPANY:_________________________________________________________________________
E-MAIL: ___________________________________________________________________________
ADDRESS/CITY/STATE/ZIP:______________________________________________________________________
PHONE:_______________________________ISPE MEMBER #/AFFILIATION:_____________________________
DRIVING DIRECTIONS and PARKING INSTRUCTIONS
Baxter Healthcare
4501 Colorado Blvd.
Building 6
Los Angeles, CA 90039
From San Diego
Take 5 Freeway North.
Exit at Colorado Street.
Exit at Edenhurst Ave. and turn Left on Edenhurst.
Turn Left onto Colorado Blvd.
Turn Right onto W. San Fernando Rd.
Baxter parking is on the right hand side.
From Thousand Oaks
Take 101 Freeway South.
Keep Left to continue on to 134 Freeway East.
Follow signs for Burbank/Glendale.
Take the 5 Freeway South toward Los Angeles.
Take the exit toward Colorado St.
Exit at Edenhurst Ave. and turn Left on Edenhurst.
Turn Left onto Colorado Blvd.
Turn Right onto W. San Fernando Rd.
Baxter parking is on the right hand side.
It is recommended that you look up directions from your starting point to make sure you
have the best driving directions.