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PDA Singapore Chapter Annual General Meeting, Data Integrity Workshop & Networking Event

Mar 24 - Mar 24, 2017 |
Mar 24, 2017 |
Blue Bali | NUS, Singapore
  • Chapter
  • Asia-Pacific
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PDA Singapore Chapter would like to cordially invite you to attend PDA Singapore Chapter AGM 2017 on 24 March 2017. The AGM will also include Case Studies on Data Integrity and Networking. The event is open to everyone.

 

Speakers

Bob Buhlmann, Director, Quality Assurance Amgen
Bob Buhlmann has been in the bio/pharmaceutical business for over 25 years, with specialized interest in 21 CFR Part 11 and Computer Systems Validation in a variety of settings, including national and international companies regulated by FDA GMP / GLP / GCP / QS Reg. in his current role at Amgen, Bob oversees the GxP Computer Systems QA Oversight Team. He is responsible for setting the validation requirements for computer systems as well as the validation of Enterprise Systems. He has developed. Implemented, and leads a global data integrity program at Amgen that is used to assist in defining the risk and controls of using a both paper and electronic data. I have worked to evaluate both internal data integrity controls and external partners, I.e. Contract Manufacturing and Contract laboratories) Bob's work has included directing several global SAP implementation projects acting as the Quality Oversight and Validation Team, provided a leadership role in developing and enforcing appropriate computer controls for GMP/GLP/GCP regulations, participating in preparing responses and corrective action plans for computer-related FDA regulatory observations, developing and implementing global and site Part 11 and computer compliance programs, advising on development of global Information Technology (IT) quality and compliance functions, developing policies and procedures, and providing training in CSV and Part 11 compliance. Bob has presented at several conferences on the topic of 'Data Integrity'. Bob has a bachelor's degree in Information Systems from University of Massachusetts, Lowell

Bruce Loxley, QA Validation and Compliance Manager GSK
Bruce Loxley is GSK Vaccines QA Validation and Compliance manager here in Singapore. He has been with GSK for 16 years in UK, France and now Singapore, working at a variety of plants ranging from Bulk API, to non-sterile secondary pharmaceuticals, with the last nine years in Vaccines operations. Prior to that he was working again in Validation, but with Jacobs Engineering, providing services to a wide variety of pharmaceuticals clients worldwide. At GSK Singapore site for almost 4 years, he helms the Validation & Compliance team with particular interests and responsibilities in Process Validation, Change Control, and now Data Integrity & Compliance issues. 

Agenda

16:00 – 16:30 Registration
16:30 – 16:35 Welcome Message Maureen Hertog (President, PDA Singapore Chapter)
16:35 – 17:05 General Principals of Data Integrity The presentation will look at ways companies can detect, prevent, and correct data integrity issues. Speakers will also comment on notable enforcement actions surrounding data integrity breaches Bob Buhlmann (Executive Director Quality, Amgen – Member of PDA Data Integrity Task Force)
17:05 – 17:45 Annual General Meeting Board Members of PDA Singapore Chapter will present the AGM report for year 2016 including account balance and plan for year 2017. PDA Singapore Chapter Board Members
17:45 – 18:30 Case Studies on Data Integrity Case studies are taken from 1st PDA Europe Annual Meeting on Jun 28 - Jun 29, 2016 at Berlin, Germany Bruce Loxley (QA Validation and Compliance Manager, GSK)
18:30 onwards Networking Drinks Take the opportunity to network with fellow PDA Singapore Chapter members Open to AGM participants 

Registration

PDA member: Free of Charge
Non-Member: SGD 10.00, payable at the registration

Please RSVP your attendance by completing this FORM to facilitate logistics arrangements. For any question, please contact Andiyanto at 9830 8536.

Blue Bali
One D Cluny Road
(behind NUS Bukit Timah Campus opposite Law Faculty Eu Tong Sen Building)
Singapore 259600
website: http://www.bluebali.sg/
Compliments of the PDA Singapore Chapter
Register Now
https://docs.google.com/forms/d/e/1FAIpQLScJTlzM5Pu9ELjyg_SvNAGNpWJlHwnyeGO13cjTDwILWknEnA/viewform

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