Data Integrity: How to Verify, Validate and Maintain (E03)
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21-22 February
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Planned and Implemented by the ISPE GAMP® Community of Practice (COP)
Data Integrity is the assurance that your data is consistent, correct, accessible and secure. This seminar will provide implementation examples which utilize GAMP® methodology in the design, testing, and implementation of different data warehouse repositories. Data warehousing becomes necessary to meet an organization’s need for reliable, consolidated, unique and integrated reporting and analysis of its data, at different levels of aggregation. Additionally, cloud computing is gaining momentum in the pharmaceutical industry. Learn from colleagues who have implemented successful cloud technology infrastructure utilizing a risk-based approach.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Understand the lifecycle management process for data
- Effectively manage and maintain data as its associated risks
- Distinguish between data integrity and data validity
- Determine what to test
- Analyze what is data and database Integrity testing
- Determine validity of a generated piece of data
- Analyze risks and challenges associated with external service providers
Who Should Attend
IT, IT Quality, QA, GAMP, Lab Analysts
Leaders
Speakers
- Jeff Campie, USA
- Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
- Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
- Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
- Edwin Melendez, Principle Consultant, Parexel, USA
- Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
- Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
- Julian Wilkins, Vice President, PharmaConsult US Inc, USA
- Paul Wreglesworth, Independent Consultant, United Kingdom
This Session relates to the following Communities of Practice (COPs)
GAMP®