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Norton Audits Government Research Opportunities
08.10.2015
To Leverage our Recent Government Experience
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Norton Audits Capabilities Statement
04.17.2015
In support of U.S. Government requests, 2015 Cap Statement released
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News Archives


Norton Audits Provides Compliance Services for Flu Study
4/15/2014
Having started in 2013 and continuing throughout 2014, Norton Audits is supporting an international flu vaccine study in both Northern and Southern Hemispheres by providing approximately 15 vendor and Clinical Investigator audits in North America, Central America, South America and Europe.  This Australian sponsor chose Norton Audits for the initial study vendor qualification audits and based on our solid performance extended our contract to include Clinical Investigator audits in 2014.
Norton Audits Continues International Expansion 
 
12/10/2012
During 2012 Norton Audits conducted sponsor-requested Clinical Investigator Training Compliance Assessments in United Kingdom, Israel, New Zealand, Greece and the United States. Vendor qualification audits were also completed in The Netherlands, United Kingdom and Canada. This adds to our previous experience conducting compliance assessments and audits in Russia, Ukraine, Spain, Germany, Poland, Romania, Mexico, Argentina, Serbia and Brazil. While conducting compliance assessments in North America remains our largest region, international audits continue to grow and now represents approximately 40% of our compliance services.
 
Sixth Annual Compliance Forum Completed
 
8/18/2012
 
Leveraging our highly successful five previous Auditing Forums and continued industry and academia compliance experience, Norton Audits conducted our 6th Annual Compliance Forum June 5-7, 2012 at the DoubleTree by Hilton in Downtown Boston, Massachusetts. A new morning-lecture-afternoon-workshops class structure was utilized to present our proven Norton Methods for GCP & ICH compliance strategies of pharmaceutical and medical device investigators, sponsors, CROs and IRBs. Lead by Norton Audits' President, former award-winning FDA Investigator and industry and academia lecturer, advisor, author and clinical trial expert Tamera Norton Smith, PhD, MT(ASCP), the Forum anchored on compliance strategies and misconduct and fraud surveillance. Additional Instructors from Norton Audits include Principal Compliance Analyst Deidra Poucher.
 
Norton Audits to Lead Vendor Oversight Training
 
1 /25/12
 
Tamera Norton Smith, PhD, MT(ASCP), President, and Deidra Poucher, MSHS, RQAP-GCP, Principal Compliance Officer, both of Norton Audits, will lead six training classes for PTI in 2012 for 'Effectively Managing Vendor Oversight'. These two day classes will be held in London, Boston and San Francisco. More information can be found at http://www.informaglobalevents.com/event/oversightusa

Keynote Presentations at France and US Conferences

11/1/2011

Tamera Norton Smith, PhD, MT(ASCP), President of Norton Audits, provided keynote sessions at the Phoenix, AZ and Lyon, France Partnerships in Clinical Trials Conferences in 2011. Having filled in for a US Food and Drug Administration Representative at the Phoenix, AZ Conference in March, Ms. Smith was also invited to speak at the Lyon, France Conference in November, 2011. Ms. Smith's keynote sessions included 'Clinical Partnerships at a Crossroad; The Intersection of Quality and Oversight' and 'What are Regulators' expectations of Vendor Oversight'.

Fifth Annual Auditing Forum a Success

10/25/2011

Leveraging our highly successful four previous Auditing Forums and continued International Auditing Experience, Norton Audits conducted our 5th Annual Auditing Forum October 25-28, 2010 in Columbia, SC. Thirty-two students learned our proven Norton Methods for GCP & ICH auditing of pharmaceutical and medical device investigators, sponsors, CROs and IRBs. Lead by Norton Audits' President, former award-winning FDA Investigator and international auditor, consultant and instructor Tamera Norton Smith, PhD, MT(ASCP), the Forum included case studies, panel discussions, expert regulation knowledge and dynamic instruction. Additional Instructors from Norton Audits included Compliance Analysts Deidra Poucher, Margo Holland and Cathy Metcalfe. Attendees included students from Boston Scientific, Allergan, Medimmune, Symbio, Palmetto Health, Marshfield Clinic, Sanofi Aventis, Georgia Health Sciences and Dana Farber Cancer Institute. 

Norton Audits Partners for Asian Clinical Research Training

3/1/2011 

Effective March, 2011, Aklima Clinical Research, headquartered in Karachi, Pakistan, will offer public training classes in clinical research utilizing Norton Training Insitute training content along with Aklima training content and local Instructors within Pakistan. While Aklima will market and conduct the training classes in Pakistan, the Norton Training Institute will ensure proper GCP and ICH knowledge through overseeing student testing and issuing final training certificates. Initial training programs to be offered by Aklima include the Norton Training Institute's Clinical Research Associate (Monitor) Training Program and Clinical Investigator and Coordinator GCP and ICH Training Program. Learn more about Aklima at www.aklimaresearch.com. 

Norton Audits to Lead Oncology Research Program Re-Start

12/15/2010

One of World's Largest Oncology Research Facilities Selects Norton Audits. With honoring our confidentiality, nondisclosure and media restrictions, few direct specifics can be provided on this endeavor including the name of this large oncology research facility. Norton Audits is leading the review, audits, training and advisement in re-opening one of the world's largest sponsor, government, investigator-initiated and grant-based oncology research facilities located in the US. After voluntarily idling enrollment and on-going research due to systemic Good Clinical Practice (GCP), International Conference on Harmonisation (ICH E6), 21 Code of Federal Regulations (US FDA) and many other regulatory body noncompliance concerns at their facility, Norton Audits was selected to conduct up to approximately 80 Investigator audits to assess these systemic concerns and individual Investigator performance. Relying on our extensive systems, auditing and risk management knowledge and experience, Norton Audits will complete these audits in approximately February, 2011 and then initiate further follow-up consulting and training.

Fourth Annual Auditing Forum a Success

11/1/2010

Leveraging our highly successful three previous Auditing Forums and continued International Auditing Experience, Norton Audits conducted our 4th Annual Auditing Forum October 19-22, 2010 in Orlando, FL at the Hilton Walt Disney World Resort.  Thirty students learned our proven Norton Methods for GCP & ICH auditing of pharmaceutical and medical device investigators, sponsors, CROs and IRBs. Lead by Norton Audits' President, former award-winning FDA Investigator and international auditor, consultant and instructor Tamera Norton Smith, PhD, MT(ASCP), the Forum included case studies, panel discussions, expert regulation knowledge and dynamic instruction.  Additional Instructors from Norton Audits included Melissa Pong, Compliance Director, Deidra Poucher, Regulatory Director and Margo Holland, Sr. Compliance Analyst.  Attendees included students from ICON, Boston Scientific, Vanderbilt, Boehringer Ingelheim and Dana Farber Cancer Institute.

Norton Audits Adds Monitoring Audits Services

5/14/2010

Monitoring Report Reviews and On-Site Monitor Audits Completed for First Clients
As part of approximately 24 international oncology investigator audits, Norton Audits completed approximately 75 Investigator monitoring report reviews to identify study noncompliance trends and to identify high risk Investigators to audit. For each Investigator on the study, Norton Audits reviewed all monitoring reports and completed a simple one-page review document complete with ratings and comments that were easily compiled into an overall Investigator risk assessment.

As part of a separate project, Norton Audits visited several Investigator sites to audit the monitoring conducted at that site against the protocol requirements, 21 CFR requirements and the sponsor SOPs and policies. 

Third Annual Auditing Forum a Success

4/1/2010

Our Third Annual Auditing Forum was held in San Francisco, CA March 2-5, 2010. 3 1/2 days of Clinical Investigator auditing training including a 2-day Auditing Fundamentals Session and 1 1/2-day Advanced Auditing Topics Session were attended by 18 research professionals from the US, Canada, Hong Kong and Japan including Sr. Monitors, Auditors and Management from Sponsors, CROs, Universities and Research Sites. Lead by Company President Tamera Norton Smith, PhD, MT(ASCP), this Forum included case studies, panel discussions, expert regulation knowledge and dynamic instruction. Other Instructors from Norton Audits included Melissa Pong, MS, CCRA, Director of Compliance and Deidra Poucher, BSN, RN, MSHS, CCRC, Regulatory Director.

Clinical Investigator Mentoring Client Wins First Studies

11/14/2009

After failing to obtain any studies from an external study placement consultant in 2008, Piedmont Health Group in Greenwood, SC was awarded three studies that initiated in early 2010. Piedmont Heatlh Group engaged Norton Audits in March, 2009 to implement Standard Operating Procedures, clinical research team training, on-site facilities consulting and winning study assistance. Since March, 2009, Piedmont Health Group has hosted Sanofi-Aventis, Merck, Bristol Meyers, GSK and i3 Research for Qualification Visits and were awarded three studies in November, 2009. We congratulate Piedmont Health Group on this initial success. Learn more about them at https://www.piedmonthealthgroup.com/research.

Sponsor Contract Auditing Services Increase

5/13/2009  

Leveraging our expertise and reputation for unique and effective auditing services, several Sponsor organizations have engaged Norton Audits to provide contract auditing services to meet their on-going clinical research needs during this transitionary economic period. These organizations include large international and mid-size US-based firms conducting research in medical devices and pharmaceuticals. Contact Norton Audits at excellence@nortonaudits.com to make your inquiry for similar auditing services.

First Annual Auditing Forum a Success

10/13/2008

Our First Annual Auditing Forum was held in Columbia, SC October 7-10, 2008. 3 1/2 days of Clinical Investigator auditing training including a 2-day Auditing Fundamentals Session and 1 1/2-day Advanced Auditing Topics Session were attended by 27 research professionals from the US and Canada, including Sr. Monitors, Auditors and Management from Sponsors, CROs, Universities and Research Sites. Lead by Company President Tamera Norton Smith, PhD, MT(ASCP), this Forum included case studies, panel discussions, expert regulation knowledge and dynamic instruction. Other Instructors from Norton Audits included Melissa Pong, MS, CCRA, Director of Compliance and Deidra Poucher, BSN, RN, MSHS, CCRC, Regulatory Director.

Norton Audits Launches Second Customer-Specific On-Line Training Portal

11/23/2007

Having demonstrated the ability to provide on-line training to the Clinical Research Industry at large since 2005, Norton Audits has commissioned its second customer-specific on-line training portal for 25 Clinical Research Coordinators and Investigators at the Washington University Sleep Medicine Center (http://washusleepresearch.coursehost.com). This on-line training portal will provide education on 25 Standard Operating Procedures, also provided by Norton Audits, and their associated Good Clinical Practices to Washington University. The advantages of the dedicated on-line training portal for this client include a custom home page with customer-specific graphics, logos, color and text, the ability to load custom training content, complete hosting and administrative services from Norton Audits, and unique reports of the training status and completions of the students. Contact Norton Audits for information on how we can do the same for your research organization and visit our Public On-Line Training Offering at http://nortoninstitute.coursehost.com

Norton Audits Speaks at Second Annual FDA Inspections Summit

09/03/2007

Tamera Norton Smith, PhD, MT(ASCP), President and Senior Consultant of Norton Audits, Inc. and former FDA Investigator, spoke at the Second Annual FDA Inspections Summit entitled "Getting it Right the First Time, Every Time".  Held October 22 thru 24, 2007 in Washington, DC, Ms. Smith presented "Upfront GCP Compliance:  Understanding Risk Mitigation for Successful FDA and Business Outcomes". 

Norton Audits Featured in 'The Monitor'

07/03/07

Recognizing Norton Audits’ 4 th year of contributing to the Annual ACRP Global Conference through a full-day Workshop, ‘The Monitor’ sites our ‘Compliance Practices: Advanced Auditing Skills for Monitors and Auditors’ as a “traditionally popular advanced level workshop” that “targets the nitty-gritty details of hands-on, skill-based auditing techniques in concert with strict adherence to good clinical practice and ICH”. This workshop was led by Tamera Norton Smith, PhD and President of Norton Audits and complimented by significant contribution from Melissa Pong, MS, CCRA and GCP Specialist for Norton Audits. Read the entire article on page 4 of ‘The Monitor’ June 2007 Special Supplement for Highlights from the 2007 Global Conference & Exhibition.

Norton Audits Presents at DIA 2007 Annual Meeting

03/02/07 

Tamera Norton Smith, PhD, and Angelo Sambunaris, MD and Medical Director of The Atlanta Institute of Medicine & Research presented "Emergency Procedures for when a Sponsor Goes Bad" on June 19, 2007 at the DIA (Drug Information Association) 43rd Annual Meeting in Atlanta, Georgia.  As part of this Session, Ms. Smith also presented "Developing a GCP Strategy for Protecting Your Clinical Research Site".

Norton Audits to Present at ACRP 2007 Global Conference   

01/18/07

For the fourth consecutive year, Tamera Norton Smith will lead two high-energy skill-focused presentations including Concurrent Session ‘How to Audit CROs and Sponsors’ and all day Workshop ‘Compliance Practices: Advanced Auditing Skills for Monitors and Auditors’.  Ms. Smith will be joined by Co-Presenter Melissa Pong, BS, MS, CCRA, Auditor and GCP Specialist from Norton Audits.  Find further information on the ACRP Conference at http://acrp2007.org.   

Norton Audits Launching First Customer-Specific On-Line Training Portal   

11/25/06

Having demonstrated the ability to provide on-line training to the Clinical Research Industry at large since 2005, Norton Audits has commissioned it's first customer-specific on-line training portal for 100 Clinical Research Coordinators, Investigators, Project Managers, and other Research Professionals at a large Research Hospital in Pennsylvania. These 100 Professionals represent 13 unique therapeutic areas, for whom Norton Audits is also deploying a common set of Research Standard Operating Procedures. The on-line training portal will provide training on these 25 SOPs as well as general Good Clinical Practices and in the near-future custom training programs will also likely be deployed for this client. The advantages of the dedicated on-line training portal for this client include a custom home page with unique graphics, logos, and text, the ability to load custom training content, complete hosting and administrative services from Norton Audits, and unique reports of the training status and completions of the students. Contact Norton Audits for information on how we can do the same for your research organization and visit our Public On-Line Training Offering at http://nortoninstitute.coursehost.com.

Existing Device Sponsor Customer Sends 10 CRAs to 2/07 Public Training Class

11.20.06

After utilizing Norton Audits for several in-house custom training classes, including 'Monitoring Through Quality Systems', a large Device Sponsor has committed to send 10 of their new CRAs to Norton Audits' next 3-day Monitoring of Clinical Investigators Training Class to be held February 20 - 22, 2007 in Columbia , SC.   Previously this Device Sponsor has utilized a large well-known national training company for their entry-level CRA training, but turned to Norton Audits for their up-to-date, regulation and skill-focused training format that includes real-world case studies from Norton Audits Auditing and Consulting Services.  Learn more about and join us for this next Monitoring of Clinical Investigators Class at http://www.nortonaudits.com/professional_services/training/TC-01.html .

Is Clinical Trial Noncompliance Allowed to Happen?  

 

10.9.06

Tamera Norton Smith, President and Senior Consultant at Norton Audits, Inc. will lead an Audio Conference on Friday, October 27, 2006 on "Is Clinical Trial Noncompliance Allowed to Happen?" .  This Audio Conference will help you learn how to demonstrate voluntary compliance and determine how to be in a constant audit ready-state.   Each research professional has the responsibility to ensure compliance is maintained throughout the clinical trial process. The monitoring and auditing process is pivotal in this assessment. Are monitors and auditors empowered to help gain compliance? What are the necessary skills for helping each professional understand their legal and regulatory obligations?  Since compliance is a prospective process and not retrospecitve, Dr. Smith's presentation will also focus on steps and programs to ensure compliance as well as key pertinent regulations that focus on securing compliance.

Norton Audits Chairs 3rd Annual 'Sustaining FDA Compliance' Conference

9.21.06

Tamera Norton Smith, President and Senior Consultant, presented a Pre-Conference Workshop on 'Risk Management - Proactive Compliance Strategies for Corporate and FDA Sucess' and chaired this 2-day Executive Conference.  Ms. Smith is a former FDA Investigator that has conducted 100s of FDA Audits herself, as well as 100s more of Mock FDA, For Cause, and Proactive Risk Analysis Audits for Pharmaceutical, Medical Device, and Biotech Sponsors, CROs, and Clinical Investigators.  Joining Ms. Smith in the Workshop was Jonas Berwick, President of Delve Information Resources, a strategic partner of Norton Audits, Inc. who will spoke on company and individual background checks, investigations, and lost-to-follow-up services as part of research risk mitigation.  Learn more about this value-rich conference at http://www.marcusevans.com/events/CFEventinfo.asp?EventID=10996 or by contacting Norton Audits at excellence@nortonaudits.com or 803-233-4809..

Norton Audits Presents at ACRP 2006 Global Conference  

5.14.06

For the third consecutive year, Tamera Norton Smith lead two high-energy skill-focused sessions including the CRA Forum Session on 'Effective Auditing Skills and Techniques for Monitors' and an all day Workshop on 'Advanced Clinical Trial Compliance Practices'. In addition, Ms. Smith presented a Poster on 'Defining and Examining Clinical Trial Noncompliance'.

Norton Audits Leads ACRP Audio Conference March 17, 2006

3.13.06

'Ensuring Drug Safety and Human Subject Protection' was presented byTamera Norton Smith, which focused on the necessary skills and understanding of the regulations that define the role of the Monitor.  

Norton Audits to Provide Subject Lost to Follow-Up Services

3.20.06

Along with Investigator and other Personnel Background Checks, and Subject Recruitment Database Searches, Norton Audits has partnered with Delve Information Resources of Lawrenceville, GA to provide this new and risk mitigating service to the Clinical Research Industry.  Delve Information Resources is a leader in the legal, financial, and insurance industries for providing these same services and has recently provided Subject Lost to Follow-Up services for Duke and Emory Universities.  Contact Norton Audits for more information.  

Norton Audits Conducts Auditing Training in Canada

1.14.06

Val Willets and Les Gee from ASKA Research in Vancouver, British Columbia invited and hosted thirteen Monitors, Coordinators and Auditors from their network of Clinical Research Professionals for a two-day Auditing Clinical Investigators Training Class presented by Tamera Norton Smith, PhD and President of Norton Audits, Inc.  This training class represents one of the first partnerships Norton Audits has created with a complimentary Clinical Research Organization, such as ASKA Research, to bring our proven and unique Auditing techniques to new geographic areas of the clinical research industry.  While Norton Audits continues to conduct Public Training Classes at its headquarters in Columbia, SC, Norton Audits will continue to partner with other research organizations to present live Public Training Classes for Auditors, Monitors, Coordinators, Investigators and others within their geographic locales.

Norton Audits Trains FDA

9.15.05

Norton Audits, Inc. (NAI); a clinical research auditing, training, and consulting services firm located in Columbia, SC, provided their Norton Method for conducting 'Scientific Investigations: Complaint Management and Advanced Interviewing Skills' training class for the United States Food and Drug Administration Center for Devices and Radiological Health’s (CDRH) Division of Scientific Investigations in June, 2005 . This customized training program took place in Rockville , MD  and was the second such training program conducted by Tamera Norton Smith, President, Norton Audits, Inc. for the FDA’s CDRH.

 

Columbia , SC (PRWEB)

 

May 4, 2005 - The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for overall product approval, product safety, consumer protection, and oversight of biomonitoring activities for all medical device products approved by the FDA. Norton Audits’ selection was based on fifteen years of clinical data auditing expertise, unyielding compliance law experience, national training reputation, and regulatory case development skills in both the medical device and pharmaceutical industries.

 

Additionally, Norton Audits announced preparations for Tamera Norton Smith to jointly present with the U.S. FDA at the 2006 Association of Clinical Research Professionals (ACRP) National Conference to be held in Phoenix , Arizona . The Center of Devices and Radiological Health has set the topic for 2006 to address Quality Systems in Clinical Trials.

 

About Norton Audits, Inc.:

 

Norton Audits’ mission continues to focus on advancing clinical research through strategic systems development and implementation for defining and driving performance excellence. Norton Audits’ most successful product is their skill set for identifying and helping their clients proactively identify and limit their risk that would prevent an approval of a New Drug Application and Medical Device Pre-Market Application. Norton Audits provides auditing, monitoring, consulting and training services and products to the Clinical Research Industry. Norton Audits, Inc. is also a member of the University of South Carolina Technology Incubator .

Norton Audits Presents at ACRP Global Conference  - Join Norton Audits President in Audio Conference Presentation Norton Audits Leads ACRP Audio Conference

Clinical Investigator Mentoring Customer Wins First Study

Dr. Robert Earle and Lynda Barker, ANP, of Bay Area Psychiatry won their first Clinical Trial Study from ICON and AstraZeneca approximately two months after completing a 2-day intensive Mentoring Session with Norton Audits, Inc.  Norton Audits provided specific training and guidance in Clinical Research Site Operations, including Good Clinical Practices, how to obtain studies and implementing several Norton Audits Site Standard Operating Procedures.  Norton Audits also supported Bay Area Psychiatry in their on-going applications for study trials and Site Qualification Visits.  We congratulate Bay Area Psychiatry in winning their first study.

 

Norton Audits Chairs 3rd Annual 'Sustaining FDA Compliance' Conference Is Clinical Trial Noncompliance Allowed to Happen?

10.12.2005

This two-day conference from Insight Information addresses the day-to-day challenges faced by the Canadian pharmaceutical sector.  Norton Audits to speak on 'Emerging Compliance for Multi-Jurisdictional Concurrent Clinical Trials'.

 

Norton Audits 'Clinical Trials Administrator' Article: 'Deal with NonCompliance before it reaches the FDA' includes Two Corrective Action Tools 

 

07.12.2005

 

In the July 2005 Issue of 'Clinical Trials Administrator', published by Thomson American Health Consultants, Tamera Norton Smith, President and Sr. Consultant for Norton Audits, Inc., discusses the main causes of and five preventative steps for research noncompliance.  Ms. Smith states that "The main causes of research noncompliance result from investigators, research staff, and industry sponsor staff misunderstanding or having difficulty interpreting regulations".

This article includes five recommended steps for achieving regulation and protocol compliance, that revolve around SOPs, training and corrective actions, including two corrective actions forms.  To view this article in full, please visit the Thomson American Health Consultants web site at http://www.ahcpub.com/online.html and search for the July 2005 Issue of 'Clinical Trials Administrator'.  You will need to have or estabish an account with Thomson to view the article in full.

 

Norton Audits Fraud Mentoring Session

 

07.28.2005

 

"I have to tell you, we are SO grateful for the tools and training that you gave us I can't even begin to tell you!  We have implemented several of your tools into this project.  We put together an action plan that we has been complemented on by numerous seasoned veterans on our team.  Due to some contractual logistics, we had to move back our arrival date of this "mission", so our first day in is tomorrow......  I will keep you updated as to our progress and may call on you if necessary for some more of your expertise.  We could not have even made it this far without you!!"

Dawn Kepler

Lead Clinical Research Associate II

OrthoLogic Corp.

 

Norton Audits Auditing Mentoring Session

 

04.12.2005

 

"Tamera's one-on-one mentorship provided me with more insight than years of training sessions could have.   Her in-depth, first-hand knowledge of the FDA regulations and practical approach to monitoring and auditing goes unmatched by any other in the industry.  Her calculated organization and personally devised tools for employee training programs and site SOPs provided me with resources that would have taken years to compile.  I only wish I would have met her years ago!"  

Dana M. Wentzel, RN, MSHSA, CCRC

Director of Clinical Research

Lehigh Valley Hospital

Allentown, PA

 

ACRP 2005 Conference & Exhibition

04.08.2005

Norton Audits Speaks at ACRP 2005 Conference & Exhibition North America in Orlando, FL April 2-6, 2005.

Tamera Norton Smith, President and Senior Consultant of Norton Audits, Inc. and Guest Speaker Dr. Angelo Sambunaris, President and Medical Director of the Atlanta Institute of Medicine and Research, conducted a very well received full-day ‘Compliance Practices for Clinical Research Professionals’ Workshop for fifty Clinical Research Professionals. 

In addition, Tamera Norton Smith, conducted a two-hour Clinical Research Associate Forum Discussion on 'Monitoring Compliance through Quality Systems' for approximately 150 ACRP members, where attendees described Ms. Smith's presentation as "truly a breath of fresh air in the monitoring world of sameness" and "I was inspired again after your presentation in a way similar that got me into this field in the early 80s".

Norton Audits, Inc. is again planning to speak at ACRP2006 in Phoenix, AZ, which will mark our third consecutive year of advancing the body of knowledge within the Association of Clinical Research Professionals Community.

National Training Center Opens

03.30.2005
Norton Audits opens their National Training Center in Columbia, SC. Classes begin June, 2005. See our Training Section for more details.

   


 
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