Current Class Dates (subject to change): May 8, 2008, Atlanta, GA

Also Scheduled as Needed based on Student Demand.  Email us at onlinetrain@nortonaudits.com if you are interested in this course.

Description - This skill-based course teaches risk management and risk control techniques for experienced clinical research coordinators or site managers who want to expand their skills. Participants will learn Good Clinical Practices from a regulator’s perspective and to perform proactive risk analysis for clinical investigations, work on completing an internal CAPA program and complete standard operating procedures for a CAPA program. The course is designed to address upcoming FDA regulations regarding Quality Systems approaches to monitoring clinical trials. 
                                                                                           
Class Agenda/Modules -                                  Instructors Make a Difference

• The Laws Governing Clinical Trials
• Risk Assessment and Risk Management
• Global Quality Systems
• Corrective and Preventative Actions (CAPA)
• Writing Effective Standard Operating Procedures
• Norton Method: Intensive Systems Development Workshop

Typical Class Attendee -

• Clinical Research Coordinators
• Clinical Investigators
• Clinical Research Directors
• Site Clinical Research Quality Assurance Auditors

Coordinating Level - Advanced; CRC or management position for two years

Class Price - $1000 (20% Southeast Regional Discount and 10% multiple persons  from the same organization discounts are available)