Lead Document Controller

The Lead Document Controller course provides critical content relating to strategies for document control, Good Documentation Practices (GDocP), and capturing contemporaneous information utilizing Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA).  The course includes a presentation of the education, experience, and skill sets for entry level and lead Document Controllers, their positions and responsibilities, and challenges and benefits. The applications are further examined within professional roles where document control is essential for regulatory compliance. 

Suggested audience includes anyone who uses Document Control practices regulated by the FDA, ISO, and/or other agencies.  This includes (but is not limited to) clinical research coordinators (CRCs), document control professionals, manufacturing and CGMP-regulated operations staff, quality assurance/quality improvement professionals, and research administrators.