at Johnson & Johnson Medical
Wednesday, 1 March 2017 from 8:45 AM to 5:00 PM (AUS Eastern Daylight Time) + Add to calendar01/03/2017 08:4501/03/2017 17:00Australia/SydneySYD - Data Integrity Workshop" - Leveraging GAMP®SYD - Data Integrity Workshop" - Leveraging GAMP®
Wednesday, 1 March 2017 from 8:45 AM to 5:00 PM (AUS Eastern Daylight Time)
Organiser
Mandy Bromilow
0447279008
manager@ispe.org.au
Address
Johnson & Johnson Medical
1-5 Khartoum Road
Macquarie Park
NSW 2113 Australia
Theatrette Training Room
Event web page: https://www.stickytickets.com.au/47131 Johnson & Johnson Medical
1-5 Khartoum Road
Macquarie Park NSW 2113
AustraliaMandy BromilowfalseDD/MM/YYYY2880
Tickets for this event are currently unavailable
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.* 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.
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.
Agenda
08:45 – 09:15 | Registration |
09:15 - 09:30 | Welcome & Introductions |
09:30 - 10:30 | Session 1 |
10:30 - 11:00 | Break |
11:00 - 12:00 | Session 2 |
12:00 - 13:00 | Lunch |
13:00 - 14:00 | Session 3 |
14:00 - 15:00 | Session 4 |
15:00 - 15:30 | Break |
15:30 - 16:30 | Session 5 |
16:30 - 17:00 | Wrap Up & Close |
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1-5 Khartoum Road Macquarie Park NSW 2113, Australia
Mandy Bromilow
ISPE
0447279008