Learn Auditing from an Auditing Company

Current Class Dates (subject to change):

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

Description -   Learn our proven 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 ‘boot camp’ to build observational, interviewing, auditing and writing skills, legal expertise, and communication and data techniques.  This forum is led by a former award-winning FDA Investigator and current field-based North American 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. Participants will gain an understanding of risk management and risk control, learn to perform proactive risk analysis for clinical investigators, and auditing techniques for narrowing parameters for audit selections, based on early warning signs obtained in the auditing process, to proactively address compliance issues.  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
• Conducting a Clinical Investigator Qualification Visit
• Corrective & Preventive Actions
• Introduction to Standard Operating Procedures
• Noncompliance Causalities & Securing Compliance at the Clinical Investigator

Auditing Fundamentals Session Modules (October 7-8, 2008, 16 Instruction Hours)

• Legal Expertise, Foundations of GCP & ICH
• Risk Assessment & Management
• Auditing Through Quality Systems
• Regulatory Writing Skills and Techniques
• Case History Requirements
• Case Studies
• Observation & Interviewing Skills
• Organization & Communication Skills
• Data Techniques

Advanced Topics Session Modules (October 9-10, 2008, 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
• Compliance Auditors
• Directors of Compliance and Quality Assurance

Auditing Level - One to ten-plus years of auditing experience or five-plus years of Monitoring, Coordinating or Similar Experience

Class Price - $2,000 (5% multiple persons  from the same organization discounts are available) 

Class Location - Hilton Columbia Center