Learn Auditing from a GCP Auditing Company

Current Class Dates:

March 2-5, 2010, San Francisco, CA

Three-and-a-half Days of Live Training Plus 8 Hours of Prerequisite On-Line Self-Paced Training Completed at Your Convenience

Attend just  Forum Session One; Auditing Clinical Investigators

Attend just  Forum Session Two; Advanced Auditing Topics

Class Size - Limited to 30 students to maximize your learning

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 education 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 GCP 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.

Feedback from Fall 2009 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

Current March 2010 and October 2009 Audit Forum Attendees:

Your Forum Leader and Primary Instructor:

Tamera Norton Smith, PhD, MT(ASCP), President, Norton Audits, Inc.

                                                                                                
Class Agenda/Modules:

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

Auditing Fundamentals Session Modules (March 2-3, 2010, 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 (March 4-5, 2010, 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 - $2,100 (various discounts packages available based on number of people, organization, etc.  call to inquire), includes pre-requisite training

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