Norton Audits, Inc. Provides Expertise to 3rd Annual Sustaining FDA Compliance Conference

Norton Audits, Inc. and Delve Information Resources will present a pre-conference workshop on "Risk Management - Proactive Compliance Strategies for Corporate and FDA Success" and host an Information Booth at the 3rd Annual ‘Sustaining FDA Compliance Conference – Advanced Tools and Techniques for Future FDA Audits’, September 19-21, 2006 in Baltimore, MD. http://www.marcusevans.com/events/CFEventinfo.asp?EventID=10996

(PRWEB) August 5, 2006 -- Tamera Norton Smith, PhD, President of Norton Audits, Inc. and a former FDA Investigator will lead this pre-conference workshop along with guest speaker Jonas Berwick, CLI, LPI, President of Delve Information Resources, a strategic partner of Norton Audits, Inc. Highlights of the Risk Management Tools provided in this workshop include Understanding the Food Drug and Cosmetic Act's Expression of Voluntary Compliance, Examining the Reasons why FDA Inspections have Negative and Positive Outcomes, Understanding Corporate GCP and GMP Risk Mitigation and Risk Management, Examining the "Causation of Noncompliance" in the GCP and GMP Arenas, and Understanding the Remodeling of Clinical Trials that will occur in the Next Year.

Ms. Smith is a former FDA Field Investigator having conducted hundreds of FDA Inspections of biologics, pharmaceutical, medical device, and manufacturing organizations, resulting in several awards for casework which lead to anti-tampering prosecutions, consent decrees, and warning letters. Her vast working knowledge of the Food, Drug and Cosmetic Act (21 CFR) and FDA experience, is combined with ten years of direct experience in the GCP, GLP, and GMP fields as a Monitor, Auditor, Instructor, and Consultant working for and with Sponsor, CROs, IRBs, and Clinical Investigators. Ms. Smith is the founder and President of Norton Audits, Inc., specializing in auditing, training, and consulting within the Clinical Research Industry.

Guest speaker will be Jonas Berwick, CLI, LPI, President of Delve Information Resources. Delve specializes in individual and company background checks, subject lost-to-follow-up, and many other investigative services that are utilized to manage risk and prevent non-compliance.

Norton Audits will also host an information booth for the duration of the conference to further introduce conference attendees to the expert knowledge, skills, and experience that Norton Audits and Delve Information Resources brings to the clinical research industry through auditing, consulting, training, and Standard Operating Procedures.

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 .

About Delve Information Resources:
Your need to know is our reason for being. At Delve we understand the difference between merely re-selling data pulled off the Internet and providing real knowledge necessary to reach a successful resolution of the matters at hand. We don't do opinions but we do provide our clients with more than "just the facts." Delve investigators bring real-world experience to every case they work.

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