How to Handle IT Systems in a Paperless Laboratory
Course Information
What? One-day class
When? Thursday 14 February 2013 0900-1600
For who? The course is aimed at managers and staff in the analysis, quality control, development, quality assurance and IT, which are entrusted with the fulfilment of regulatory requirements in analysis and quality control, or would like to develop in this regard.
Program: The training course will adress the latest regulatory vision and interpretation in relation to computerized systems (including 21 CFR Part 11, EU GMP Annex 11) ad will explain the procedure for the implementation of validated computer systems (especially GAMP5). While 21 CFR Part 11 is the pharmaceutical industry standard, there is little difference between these requirements and the requirements in e.g. ISO 17025, ISO 9001, and other standards. The goal is simply to have control over your IT systems and in a paperless lab this is even more important. This class teaches you how to be in compliance with the regulations.
- Regulatory requirements
- 21 CFR Part 11 (including New Guidance)
- EU GMP Annex 11
- OECD Guidelines
- Implementation
- GAMP5
- classification
- V model
- Technical Aspects
- qualification of hardware and software
- Dealing with Legacy Systems
- Different classes of device control software
- Definition of raw data
- integration into overall systems
- Maintain the validated status
- Change Managemen
- logs
- Reviews
Teachers: Siri Segalstad, Segalstad Consulting AS
Peter Boogaard, Vialis AG
Where: Thon Hotel Linne, Statsråd Mathisens vei 12, Oslo. Norway
Cost: Registration before 01-Jan-2013 NOK 4500 or 600 Euro.
Later registrations NOK 5000 or 675 Euro.
Costs includes Training, Lunch & beverages, Certificate of attendance, Full set of documentation: Memory stick with presentations and background material
About the teachers: The teachers both have 20+ years of working with laboratory information management systems (LIMS), and compliance in the pharmaceutical industry and in other industries. Siri Segalstad has written the textbook “International IT Regulations and Compliance”, which is used at the Hogeschool Gent, Belgium where she teaches several classes. Peter Boogaard has extensive experience in laboratory management to enable cross-functional collaboration between research, development, quality assurance and manufacturing corporations to achieve Quality by Design (QbD) initiatives and has written many publications on compliance themes.