Learn Auditing from an Auditing Company

Current Class Dates (subject to change):

2008 Dates and Locations are Forthcoming;  Two Days of Live Training Plus One Day of Prerequisite On-Line Training

Part of our Norton Method Auditing Forum, which includes 1 1/2 days of Advanced Auditing Topics Instruction October 9-10.  Attend either session or both.

Description - This skill-based course is designed to address FDA regulations regarding Quality Systems approaches to auditing clinical trials. The training program is led by a former award-winning FDA Investigator and current field-based auditor that teaches Good Clinical Practices (GCP) 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

• The Laws Governing Clinical Trials taught from the FDA's Point of View
• Risk Assessment and Risk Management
• Global Quality Systems for Auditors
• Norton Method: Intensive Auditing Skills Workshop for:
  • Interviewing
  • Communication
  • Observation
  • Data Techniques
  • Writing
  • Organization
  • Legal Expertise
• Severe Noncompliance and Scientific Misconduct
• Essential Writing Skills for Auditors

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 - Beginner to two years of auditing experience or five-plus years of Monitoring or Similar Experience, preferably with a four-year medical or science degree

Class Price - $1400 (5% multiple persons  from the same organization discounts are available) 

Class Location - Hilton Columbia Center