Data Integrity Will Issues around Data Integrity Ever End? Will Future Technologies Reduce the Risk?

Thursday, December 5, 2019

4:00 - 7:00 pm

Poster Display from Local ISPE LA Student Chapters

Sponsorships Available Location: Grifols, 2410 Lillyvale Ave, Los Angeles, CA 90032 Schedule and Speakers: 4:00 - 5:30 pm Registration, Appetizers Served, Networking with Attendees and Sponsors 5:30 - 7:00 pm Program Atara Biotherapeutics Strategy to Become a Paperless Plant Presented by: Joe Maguire, Senior Director, Regulated IT, Atara Biotherapeutics, Inc. Amgen’s Data Integrity Program Presented by: Bob Buhlmann, Director, Corporate Quality Assurance, Amgen Inc. Data Integrity: ISPE’s New Baseline® Guide 5 Commissioning and Qualification and Challenges of Moving to a Paperless Validation System Presented by: Ron Brunelle, Quality Assurance Director, Amgen Program Managers: Nick Haycocks, Senior Specialist QA, Amgen Inc. Merritt Postma, Director Western Region, SKAN US

Data Integrity Will Data Integrity Ever End? Will Future Technologies Reduce the Risk?

Thursday, December 5, 2019

Synopsis Atara Biotherapeutics Strategy to Become a Paperless Plant Presented by: Joe Maguire, Senior Director, Regulated IT, Atara Biotherapeutics, Inc. “Atara is committed to delivering a paperless plant, but it needs to be implemented in phases with a strong strategy to be successful.” Items to be discussed are: 1. Atara IT strategy 2. Atara IT phased approach 3. High level Atara systems slide 4. Obstacles for our small company a. Roles/Responsibilities b. Decision makers c. Configuration vs Customization d. Data integrity 5. Keeping the end in mind a. Validation b. Data management c. Labels d. Reports Amgen’s Data Integrity Program Presented by: Bob Buhlmann, Director, Corporate Quality Assurance, Amgen Inc. Items to be discussed are: • Contract labs • Outsourced manufacturers • Transition from data integrity to data quality Data Integrity: ISPE’s New Baseline® Guide 5 Commissioning and Qualification and Paperless Validation Presented by: Ron Brunelle, Quality Assurance Director, Amgen Items to be discussed are: • New ISPE Baseline Guide 5 Commissioning and Qualification • Challenges and opportunities of moving to a paperless validation system

Data Integrity Will Data Integrity Ever End? Will Future Technologies Reduce the Risk?

Thursday, December 5, 2019

Speaker Bios Joe Maguire, Senior Director, Regulated IT, Atara Biotherapeutics, Inc. Joe Maguire is responsible for the strategic direction on regulated (FDA, EMA, SOX) IT systems for technical operations, data management, biometrics, clinical operations and commercial products at Atara. He has constructed and lead a team for the design of the new facility’s regulated IT csystems; focusing on creating a paperless manufacturing facility driving efficiency in operations, review and release and data management. Joe has a BS in Chemical Engineering from Drexel University, and an MBA from Pepperdine University. Bob Buhlmann, Director, Corporate Quality Assurance, Amgen Inc. Bob Buhlmann is responsible for representing quality in the enterprise wide computer systems at Amgen. In this capacity he has been working with the quality, business units and information systems to implement systems such as SAP, LIMS, and MES at Amgen. Bob has been working in the computer validation space for more than twenty years as a consultant for Parexel International (Formerly KMI) and in the industry for Aventis-Behring and Perrigo. His validation experience ranges from QC Lab instruments to complex Global SAP systems. He holds a BS in Information Systems. Ron Brunelle, Quality Assurance Director, Amgen Ronald Brunelle is responsible for representing quality in the facilities and engineering space at Amgen. In this capacity he has been working with the quality and engineering organizations to create a better, cheaper, and faster, qualification methodology at Amgen. He has been working in the validation space for more than twenty years. As a contractor and consultant for Parexel International, he has worked with most major Pharmaceutical and Biotech companies. His validation experience ranges from simple manufacturing equipment to complex DCS systems as well as large computer software systems such as SAP. Ron has a BS in chemical engineering from the University of Massachusetts at Amherst.

Data Integrity Thursday December 5, 2019 REGISTRATION FORM and INSTRUCTIONS To Register and Receive an immediate receipt, follow these instructions: 1) Click on the link below then log on using your username and password: http://www.atdevents.net/register.php 2) Click on the appropriate event. Here is where you can download the event flyer also. 3) Scroll through the list of registration options and find the one that applies to you. 4) Select the payment option of your choice and follow instructions to pay. Make sure to go through all of the steps until payment is confirmed. Since our site has to go to the merchant account site, there are a couple extra clicks involved. ISPE California Chapter 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 (takes a few days after joining). You will need your username and password to log on. How To Find Your ISPE Member Number or Update Your Account to a Member Account: To update your existing account to a Member account, or to add your new ISPE Member account to our website, please forward your confirmation email from ISPE or your ISPE Membership information to Rob Fleming (rob.fleming@yahoo.com). We need your Chapter name, your ISPE Member number and expiration date. To retrieve this information, log onto the ISPE website. Click on "Account" on the top right side, then "My Account". Your Membership information (not including your chapter affiliation) is on the left side. Please take a screen shot or make a pdf of the page, then email it along with the name of your chapter to Rob Fleming to update your profile on the atdevents.net site. 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 then follow the instructions to update your account to a member account (see above). Non Members: If you do not have an account, you can set one up on the site using letters (not numbers) as your username. Fax Registrations: Fax your completed Registration Form with credit card payment to (949) 266-8461. Pay by Check: Register online to hold your spot. Mail your check no later than one week prior to the meeting. Make checks payable to: ISPE Greater Los Angeles Chapter, 5319 University Dr., Suite 641, Irvine, CA 92612. Tax ID#95-4452996. Email Rob.Fleming@yahoo.com for Help with Online Registration, To Set up an account, Reset password, Obtain a receipt or to Cancel your Registration (email by November 25, 2019 for refund. After the cancellation date if you have reserved a space but do not attend, your payment MUST be remitted, however, an alternate person may attend in your place. If the alternate is not a member, they will need to pay the additional amount for non-members.) Name badges will be given at the event. ________$85 ISPE Members ________$115 Non-Members ________$50 YP Members

________Free ISPE Student Members (Help at Registration table and during the event is Required)

________Free for first 20 Grifols Employees (does not apply to contractors working at the site, presenters not included in 20)

________$40 Government, Non ISPE Students and Additional Grifols Employees

________$500 Event Sponsor (includes table at event and 2 attendees)

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Parking and Driving Instructions

Grifols 2410 Lillyvale Ave Los Angeles, CA 90032 From All Points: Take 710 Freeway North to the end of the Freeway.

Turn Left onto W. Valley Blvd.

Take the 1st Right onto Mariondale Ave.

Turn Right onto Lillyvale Ave.

Grifols will be on the Left site.

Please check with security for parking instructions