Learn Auditing from a GCP Auditing Company
Current Class Dates (subject to change):
October 21-22, 2010, Orlando, FL, Hilton Walt Disney World Resort
One-and-a-half Days of Live Training
Plus 6 Hours of Complimentary On-Line Self-Paced Training
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.
|

|
Hilton Walt Disney
World Resort
Located at Downtown Disney
with restaurants, shopping and entertaining
and which accesses all Disney parks and activities
|
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 and Spring 2010 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
-
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 and Updated
Guidance
- Investigating and Securing Noncompliance
- Clinical Study Report (CSR) Auditing
- Auditing IRBs, Sponsors & CROs
- CAPA Plans including Investigative Action Plans
- Responding to Form FDA 483
- International Auditing Exposure and Tips
- Hands-On Workshops and Work Stations
- ‘Sleeping Beauty’ and other 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 - Hilton Walt Disney Word Resort, Orlando, FL
|

|
Located at Downtown Disney
with restaurants, shopping and entertaining
which accesses
all Disney parks and activities
|
|