Learn Auditing from an Auditing Company

Current Class Dates (subject to change):

2008 Dates and Locations are Forthcoming;  One-and-a-half Days of Live Training Plus One Day of Prerequisite On-Line Self-Paced Training

Part of our Norton Method Auditing Forum, which includes 2 days of  Auditing Clinical Investigator Fundamentals Instruction October 7-8.  Attend either session or both.

Description - Learn our proven Advanced Norton Methods for GCP & ICH auditing of pharmaceutical and medical device investigators from our expert approaches, skills and techniques. This dynamic program is an intensive case study and panel discussion-driven focus on identifying and addressing noncompliance, risk management and advanced auditing approaches.  The training program is led by a former award-winning FDA Investigator and current national and international auditor that teaches Good Clinical Practices from a regulator’s perspective to help participants understand their roles and responsibilities as auditors and agents of the law. Learn the Norton Method for Systems-Based Auditing that identifies the true root causes of noncompliance, and not to simply rely on audit checklists.

                                                                                           
Class Agenda/Modules -                                  Instructors Make a Difference

Pre-Requisite On-Line Self-Paced Training (Completed Prior to Class, 8 Instruction Hours)

• Legal Training for Determining Qualifications of Clinical Investigators
• Corrective & Preventive Actions
• Auditing Skills for Monitors
• Issue Resolution Techniques: R.E.S.E.A.R.C.H. Skills 
• Noncompliance Causalities & Securing Compliance at the Clinical Investigator

Advanced Auditing Topics Modules (12 Instruction Hours)

• The Food, Drug and Cosmetic Act, Related Acts, Regulations, Doctrine and Guidance
• Identifying, Investigating and Securing Noncompliance
• Risk-Based Auditing Approaches and Plans
• Auditing IRBs, Sponsors & CROs
• Auditing Skills and Techniques Workshop
• Case Studies 

Typical Class Attendee -

• Sponsor Auditors
• Senior Monitors or Clinical Research Associates/CRAs
• Contract Research Organization Auditors
• Institutional Review Board Internal Auditors
• Site Clinical Research Quality Assurance Auditors
• Independent Consultant Auditors
• GCP Compliance Auditors

Auditing Level - Two to ten-plus years of auditing experience or five-plus years of Monitoring or Similar Experience

Class Price - $1200 (5% multiple persons  from the same organization discounts are available) 

Class Location - Hilton Columbia Center