Learn Auditing from a GCP Auditing Company

Current Class Dates (subject to change):

March 2-3, 2010, San Francisco, CA

Two Days of Live Training Plus 8 Hours of Self-Paced Prerequisite On-Line Training

Part of our Norton Method Auditing Forum, which includes 1 1/2 days of Advanced Auditing Topics

Description - This skill-based course is designed to address FDA regulations regarding Quality Systems approaches to auditing clinical trials. The educational GCP 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.

Feedback from Fall 2009 Auditing Clinical Investigators Class as part of our Auditing Forum includes:

"I thoroughly enjoyed the Annual Audit Forum. All of the information was well prepared and supported by practical experience in the field. It was definitely beneficial to me as a Director responsible for the GCP Audit function."  Senior Director GXP Compliance, Device Sponsor

"I've already decided on revisions to my audit reports, my audit processes and to begin the process of introducing the escalation process to the company for which I work.  Loved Instructors' humor and real world examples."  Lori, Quality Assurance Manager

"Excellent Program - looking forward to bringing my revitalized passion for research compliance back to my organization.  Tools and examples of real situations you could encounter are priceless.  The Instructor is an amazing presenter and exceptional storyteller.  You will not find someone more qualified in the area of clinical research compliance to present this material."  Anne, Sr. Auditor, Device Sponsor

"The course has probably saved us much time/effort in our department activities.  The willingness to share materials is truly awesome."  Jenifer, Sr. Manager, Process Improvement & GCP Compliance, Canadian Pharmaceutical Sponsor

"I can better explain to our organization the reasons and interpretation of the regulations and how it effects daily interactions with PIs/CIs.  Instructor was very responsive to questions raised during course and willing to discuss additional topics."  Allie, Sr. Clinical Quality Specialist, Device Sponsor

"Being brand-spanking new to this part of research, this training creates a rock-solid foundation for everything I will do from her on."  Michael, Chief Operating Office, CRO

                                                                                            
Class Agenda/Modules -                                  Instructors Make a Difference

Pre-Requisite On-Line Training - Completed Prior to Class on Your Schedule, Approximately 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
• Technical Writing Skills and Audit Reports

Live Auditing Fundamentals Session Modules 

• 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 - $1500 (5% multiple persons  from the same organization discounts are available), includes pre-requisite on-line training

Class Location - San Francisco, CA - Hilton San Francisco Airport