Learn Auditing from a GCP Auditing Company

Current Class Dates (subject to change):

March 4-5, 2010, San Francisco, CA

One-and-a-half Days of Live Training Plus 8 Hours of Prerequisite On-Line Self-Paced Training Completed on Your Schedule

Part of our Norton Method Auditing Forum, which includes 2 days of  Auditing Clinical Investigator Fundamentals

Attendees of this Advanced GCP Auditing Topics Class must attend the Norton Audits Auditing Clinical Investigators or similar class.

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 education 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.

Feedback from Fall 2009 Advanced Auditing Topics 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
• 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
• Technical Writing Skills and Audit Reports

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 - $1250 (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