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Description
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. The course 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.
This new course joins CITI Program’s Biotility @UF series.
Audience
Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Faculty, Investigators, Research Administrators, Research Personnel, Students
Meet the Author
Marie Conzone, BS – Cadence Florida
Marie has over 15 years of experience in quality, training, product compliance, and specifically controlled documents relating to FDA regulations and ISO standards. She has a Bachelor of Science in Healthcare Management and is currently the Document Control Specialist for Cadence Florida.
