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Description
This course introduces the principles and practices of document control, with emphasis on Good Documentation Practices (GDP), ALCOA principles, and data integrity. Learners explore document life cycles, electronic document management systems, and the roles, responsibilities, and skills required of lead document controllers.
Note: This Biotility at the University of Florida course is offered by CITI Program.
Audience
Clinical Research Coordinators (CRCs), Document Control Professionals, Manufacturing and CGMP-regulated Operations Staff, Quality Assurance/Quality Improvement Professionals, Research Administrators
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.
