Lead Document Controller

The Lead Document Controller course provides a review of the document control process, the records in document control and the Good Documentation process (GDocP) and Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) processes.  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.

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.