This course is designed for Quality, Data Management and IT personnel responsible for Clinical Data Systems implementation, operation and compliance. The course is of special value to personnel seeking experience with the quality issues associated with regulated computer systems and data management of clinical research in Pharmaceutical industries.

The course is designed to provide tools needed to prepare for a Clinical Data System inspection and to assess risk areas that need prioritization. Attendees will learn how to review the system for regulatory vulnerabilities and to develop an action plan intended to close those gaps.

This course will analyze the organization of the ICH Common Technical Document and compare these with those previously specified by the Code of Federal Regulations for IND's, NDA's, ANDA's and BLA's. It will give clear and concise assistance to participants on the creation of all sections of the new document, and how to use data that is generated according to 21 CFR part 11, under GLP, cGMP and GCP rules. Early understanding of the new format rules will ease the mandated changeover. This course will give knowledge to the student how to set companies correct path of compliance.

Additionally this course requires 40 hours of internship / project.