September 18, 2013
Holiday Inn, Eindhoven, The Netherlands
What? One-day class
When? Wednesday 18 September 2013 09.00-16.00 Eindhoven (Holiday Inn - nearby train station/free parking available)
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 fulfillment of regulatory requirements in analysis and quality control, or would like to develop in this regard.
Program: The training course will address 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.
21 CFR Part 11 (including New Guidance)
EU GMP Annex 11
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
Teachers: Siri Segalstad, Segalstad Consulting AS & Peter Boogaard, Industrial Lab Automation
Cost: 700 Euro & VAT
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.
Additional information and registration http://www.industriallabautomation.com/T20130918.php