Learn Auditing from a GCP Auditing Company

Current Class Dates:

October 25-28, 2011 in Columbia, SC.  REGISTRATION NOW OPEN.

Three-and-a-half Days of Live Training

Attend just  Forum Session One; Quality Systems Auditing Fundamentals

Attend just  Forum Session Two; Advanced Auditing Topics

Class Size - Limited to 50 students to maximize your learning

Description -   Aquire proven Norton Methods skills and techniques for GCP & ICH auditing of pharmaceuticals, medical device and biologics Investigators, sponsors, CROs and IRBs from our expert level skills and techniques for industry and academia.  

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 and Spring 2010 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

Past and Current Audit Forum Attendees, include employees of:

Your Forum Leader and Primary Instructor:

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

                                                                                               
Class Agenda/Modules:

Quality Systems Auditing Fundamentals Session Modules (October 25-26, 2011, 16 Instruction Hours)

• State of the Industry
  • Updates and trends: FDA and Global Regulatory Efforts
  • Latest regulatory frameworks and metrics
• Legal Expertise, Foundations of GCP/ICH
  • Learn how to properly apply regulations
  • Learn standards auditing methodology
• Risk-Based Auditing of Protocols
  • Auditing to protocols
  • Programs for industry and government protocols
• Quality Systems Auditing Model
  • Methods for auditing investigators, sponsors/CROs, IRBs and other vendors
• Audit Process
  • Tools provided for the compete audit process
  • Risk-Based Methodology
• Seven Auditor Proficiencies
  • Legal expertise
  • Data techniques
  • Organization skills
  • Writing skills
  • Observational skills
  • Communication skills
  • Interviewing techniques
• Scientific Misconduct
  • Recent cases and trends
  • Techniques and approaches
• Primarily Demonstrated Through Clinical Investigator Audit Case Studies and Examples

Advanced Topics Session Modules (October 27-28, 2011, 12 Instruction Hours)  

• General Session: 4 hours
  • Designing and Measuring Audit Metrics
  • Auditing Sponsors and Contract Research Organizations 
• Concentrations: 2 - 4 hours each
  • Advanced Auditing of Sponsors and Contract Research Organizations
  • Investigating and Securing Compliance
  • QA/QC Role in the FDA Inspection Process
  • CAPA Plans including Investigative Action Plans
  • Advanced Scientific Misconduct

 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 - $1,995 (various discounts packages available based on number of people, organization, etc.  call to inquire), includes lunch and breaks

Class Location - October 25-28, 2011 in Columbia, SC.