Compact knowledge with focus on practical applications
BioMedion offers training workshops for technical and regulatory topics. Our workshops are typically lectured as in-house seminars at the customer's site. This way we can focus on the specific needs and questions relevant to each particular customer.
All workshops are geared towards practical applicability.
Workshops
21 CFR part 11 Compliance Workshop
The aim of this workshop is to supply an overview about requirements and implications of FDA's rule 21 CFR part 11 - electronic records, electronic signatures. This workshop serves as foundation to compliance projects and as basic training for anyone who is responsible for 21 CFR part 11 compliance.
Target audience: Management, IT, QC, staff from R&D, clin. research and production.
Duration: 1 day
21 CFR part 11 Compact training for IT staff
This workshop covers the essential requirements and implications of 21 CFR part 11 and other GxP rules for the IT department.
Target audience: IT management, administrators, QC
Duration: 1/2 day
Good IT-Compliance Practices
This workshop teaches practical approaches to running and maintaining central IT services in 21 CFR part 11 regulated environments. The aim is to demonstrate, how to organize the administration of central IT services in such a way as to maintain full regulatory compliance and at the same time minimize any additional overhead.
Target audience: IT management, administrators, QC
Duration: 1 day
IT-Audit Training
Training workshop to prepare IT staff and regular users for questions, methodology and pitfalls of computerized system audits within the framework of regular GxP-related audits.
Target audience: IT, QC, end-users
Duration: 1 day
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21 CFR part 11 Compliance Workshop Program
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