How do we do 21 CFR Part 11 training?

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There are a number of training possibilities by various training centers catering to the pharmaceutical industry. Segalstad Consulting may also give training on request.
The most successful training in your company before starting a 21 CFR Part 11 project will be done as a course and workshop lasting several days. The trainers should of course be persons with extensive knowledge of Part 11. The class should cover:
• Understanding of what the regulation is and its interpretation
• Assess a couple of systems together in the class
• Let the participants assess a system under guidance, and discuss along the way, as well as plenary with the rest of the participants in the class
• Let the participants assess a system without guidance, and discuss the results in plenary with the rest of the participants in the class
• Only this way can you be relatively certain that the interpretation is the same for all assessors. And rest assured: Even after having assessed 100 systems you will find a new variation which will make you wonder if you really had a complete understanding of 21 CFR Part 11...
• The Guidance to Part 11 document may help you in your interpretation. It can be retrieved from fda.gov/ora/