Controlled documents include company documents such as company policies, work procedures and manuals, product documentation, guidelines, datasheets, and ISO documentation. This course provides learners with the skills needed to write controlled documents that minimize the risk of misinterpretation. It discusses change controls and the end-to-end document control process and emphasizes the importance of document integrity and control in maintaining regulatory compliance. It highlights the golden rule of controlled documents: if it is not documented, then it was not performed.
The ideal audience for this course is: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Faculty, Investigators, Research Administrators, Research Personnel, and Students.
This course is powered and delivered by CITI Program. To learn more about this course and to register, please visit the CITI Program website.
