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Event Details

Overview

ISPE is pleased to provide advance notice for the forthcoming "Data Integrity Workshop" - Leveraging GAMP® to manage data integrity in the full product Life.

This one-day workshop will feature interactive case studies and presentations that examine the multiple facets of data integrity, such as quality culture, human behaviour, training needs and technology requirements.


Take Back to Your Job:

* Understanding of key issues and current regulatory expectations surrounding data integrity
* Overview of the new ISPE Electronic Record – Data Integrity Guide
* Industry best practices and mitigation strategies for data management and accountability

Who should Attend?

Quality and validation specialists, engineers, technical professionals, managers and vendors who develop, use, support or validate GxP computerised systems.


Presenters:

Charlie Wakeham has more than 15 years' industry experience developing and validating computerised systems for regulated production and laboratory environments. A long time and active ISPE GAMP® member, she is Waters Corporation's Regional CSV Consultant, providing validation services and presales support for Waters' Laboratory Informatics solutions to regulated manufacturers throughout APAC region. Charlie leads a sub-group of the GAMP Data Integrity Special Interest Group that published series of articles on the human impact on data integrity.

Tracy Clemmer has more than 20 years of experience in the validation of regulated computerised systems. Tracy is the Director of Protek Consultants, a provider of commissioning, validation and compliance services. She provides regional GAMP® training for ISPE and is a current board member of the ISPE Australasia Affiliate.

Agenda

08:45 – 09:15Registration
09:15 - 09:30Welcome & Introductions
09:30 - 10:30Session 1
10:30 - 11:00Break
11:00 - 12:00Session 2
12:00 - 13:00Lunch
13:00 - 14:00Session 3
14:00 - 15:00Session 4
15:00 - 15:30Break
15:30 - 16:30Session 5
16:30 - 17:00Wrap Up & Close
  • Agenda subject to change.
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Location
City Convention Centre

300 Flinders Street Melbourne Melbourne 3000, Australia


Organiser Information

Mandy Bromilow
ISPE
0447279008

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