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First Annual Auditing Forum A Success
10.13.2008
Expert Training, Panel Discussions, Case Studies and Techniques Presented
(More)
Norton Audits Increases International Auditing Experience
08.05.2008
Audits in Russia, Poland, Ukraine, Romania and Germany add to North American Expertise
(More)

Advanced Auditing Topics

A Norton Method Skill-Based Training Program


Learn Auditing from an Auditing Company

 

Course Number:  TC-12                                      

Class Length:       Two-and-a-half days            

  pdf_icon.gif  Class Brochure

  pdf_icon.gif  Registration Form



Current Class Dates (subject to change):

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

Part of our Norton Method Auditing Forum, which includes 2 days of  Auditing Clinical Investigator Fundamentals Instruction October 7-8.  Attend either session or both.

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 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.

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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
  • 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

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 - $1200 (5% multiple persons  from the same organization discounts are available) 

Class Location - Hilton Columbia Center  

       

 

Located in the Vista area of Downtown Columbia

Including shopping, restaurants and entertainment

Group room block expires September 24, 2008

     

 


 
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