Courses are intended for system users and system administrators working in regulated environment who are looking for an update on the latest thinking in system validation and compliance
Thermo Electron has announced the programme for a series of three-day training courses on computer system validation to take place at the company's facilities in Altrincham, UK and Beverly, Massachusetts, USA between August and December 2003.
The courses are intended for system users and system administrators working in regulated environment who are looking for an update on the latest thinking in system validation and compliance.
The programme has been designed to put into practice the tools and techniques, including risk-based approaches, to help with many aspects of the system validation lifecycle and compliance with FDA's 21 CFR Part 11 ruling on electronic signatures and electronic records.
Best known for its Lims products (SampleManager and Nautilus), chromatography data system (Atlas) and data archival and knowledge management (eRecordManager), Thermo1s informatics business was formerly known as Thermo LabSystems and Thermo Galactic.
The courses, each of which comprise twelve individual hands-on workshops, will be held in Altrincham, UK on 19-21 August, 21-23 October, and 9-11 December 2003.
They will also be held in Beverly, MA on 9-11 September and 18-20 November.
Experienced members of Thermo's education services team, together with validation specialists, will host each course.
The courses have three clear aims: To provide an awareness of computer software validation, by tracing a selection of user requirements through a complete validation lifecycle.
To examine 21 CFR Part 11 and its implications for companies, individuals, and computer systems, and to provide valuable insight into the latest guidance.
To provide practical hands-on training in proven tools and techniques that can be used in computer systems validations and 21 CFR Part 11 remediation projects.
Thermo Electron claims to be particularly well qualified to conduct these courses, due to its strong track record of assisting customers to comply with regulatory requirements, such as 21 CFR Part 11, and GxP.
In devising the programme, the company also benefited from its knowledge of the use of laboratory equipment, techniques, and processes, plus its competencies in the efficient use of information technology, including software and applications, networking issues, operating systems and information security.
Thermo's informatics business also offers a range of system validation services, ranging from needs and risk assessments consultancy through to planning and execution of the testing itself, including the application of automated testing technology.
