Week 4
(2 half days)
Tuesday 19 Jan 2021 – 1:00 pm to 5:00 pm Singapore time (5:00 am to 9:00 am UK time)
Thursday 21 Jan 2021 – 1:00 pm to 5:00 pm Singapore time (5:00 am to 9:00 am UK time)
Computer System Validation (CSV) Webinar
With increasing computerised systems entering pharmaceutical R&D, manufacturing, distribution and pharmacovigilance (MES, EMS, DCS, ERP, Safety…), No deviation has identified the need to keep our team up to date with the latest CSV approach. Who better than Chris Reid (a member of the Global and European GAMP® Steering Committees and with over 25 years experience in this space) to tackle this challenge?
We have organised this online, giving you and your organisation a unique opportunity to catch this series of Computerised Systems Validation webinars at a unique price, and gain valuable insights into current expectations and the future trends in computerised system validation and assurance.
The webinar refers to the principles of GAMP and the practical experience of effective computerised system validation and qualification.
The content will address:
GAMP principles
General approach to CSV
Risk-based approach and saleability
Data Integrity
Alternative methodologies (V Model, Iterative, Agile)
IT infrastructure management and control
Effective validation planning and execution
Current trends
• Agile
• Artificial Intelligence
• XaaS (Infrastructure & Software)
• Automation/Robotics
• Use of tools vs documentation
• Leveraging good IT practice
Vendor management and leveraging vendor effort
Maintaining the validated state during operations and retirement
Benefits
This training addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. Equip yourself with practical knowledge to start 2021 and progress your career by staying updated with the skills you will need to tackle the future of pharmaceutical manufacturing.
An attendance certificate will be provided.
You can acquire ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems here.
Webinar dates and timings:
January 2021
Week 5
(2 half days)
Tuesday 26 Jan 2021 – 1:00 pm to 5:00 pm Singapore time (5:00 am to 9:00 am UK time)
Thursday 28 Jan 2021 – 1:00 pm to 5:00 pm Singapore time (5:00 am to 9:00 am UK time)
Half-day Q&A
Friday 29 Jan 2021 – 1:00 pm to 5:00 pm Singapore time (5:00 am to 9:00 am UK time)
If you’re interested to know more...
Chris Reid
CEO of Integrity Solutions Limited
Christopher Reid is the CEO of Integrity Solutions Limited, a quality and compliance solutions provider for regulated companies globally, and a member of the Global and European GAMP® Steering Committees. He has worked with multiple industries, such as pharmaceuticals, biotechnology, medical devices and cosmetics. His experience spans all regulatory domains including clinical, laboratories, manufacturing, distribution and pharmacovigilance. Mr. Reid has spent over 20 years working in the life sciences sector, before which he was a computerised system development engineer.
He has contributed to the development of GAMP 5 and a variety of GAMP® Good Practice Guides.
