PDA Singapore and Australian Chapter Webinar - Data Integrity & Quality Culture
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PDA Singapore Chapter and Australia Chapter are pleased to co-organise our first Virtual Symposium together. In the first Webinar of the year, we will look at Quality Culture and its impact on Data Integrity. Three distinguished speakers have agreed to participate in this Webinar:
- Bruce Loxley, Senior Manager – Audit I & TPO, GSK Vaccines - also President of PDA Singapore Chapter
- Wallace Torres, Vice President of Manufacturing, Amgen
- Paul Kerr, Director SeerPharma
Join us and our pharmaceutical colleagues to get their insights in this FREE Virtual Symposium and participate in the online discussion on 21 May 2020, from 8:00 AM - 11:00 AM (Singapore time) / 10:00 AM - 01:00 PM (Australia time).
Let us listen and share about Quality Culture and its impact on Data Integrity together with colleagues from the Pharmaceutical Industry.
Agenda
Discover What's Happening Each Day
Data Integrity – Focus on Microbiological Testing Challenges
Speaker: Bruce Loxley - Sr. Manager, Audit I & TPO
GSK Vaccines Singapore
Key Points:
- 1. Why assuring Data Integrity in the Micro Lab provides for some unique challenges
- 2. Differences between improper practices and fraud (both of which give rise to DI issues) in the Micro Lab.
- 3. How DI issues can be minimized by assessing these tests against ALCOA principles.
Data Integrity – Focus on Quality Culture
Speaker: Wallace Torres - Director of Quality
Amgen Singapore
- 1. Importance of a robust Quality Culture as the basis for proper Data integrity practices.
- 2. Relationship of Data Integrity issues mentioned in recent regulatory citations and the applicable concepts in a robust Quality Culture.
- 3. PDA Quality Culture Initiative and the different components linked to a responsible Data Integrity program.
Key Points:
Data Integrity – Will the Cloud Reign?
Speaker: Paul Kerr - Director
Seer Pharma
Key Points:
- 1. Cloud services in the GMP environment
- 2. Challenges associated with preserving data integrity in the world of cloud computing
- 3. What agreements need to be included in contracts with cloud service providers in order to ensure data integrity?
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