Noverant CEO Is Keynote Speaker at ISPE-CaSA Leadership Symposium

RALEIGH, NC — Dr. Frank Gozzo, CEO of Noverant, Inc., will speak on Feb 7 at the Leadership Symposium sponsored by the South Atlantic chapter of the International Society for Pharmaceutical Engineering (ISPE).

Francesco (Frank) Gozzo is the president and chief executive officer of Noverant, Inc., a global provider of information, training and compliance management services. He led the acquisition of the company in 2006 and has driven consistent growth of Noverant in the pharmaceutical industry and expansion into 11 additional vertical markets worldwide.

Dr. Gozzo was with IBM from 1985-1995, where he served in various leadership roles including member of the President’s Technology Advisory Board. From 1995-2006, he held executive and board roles at Bell & Howell, where he led the privatization, turn-around, and subsequent sale of the business. He earned a doctorate in electrical engineering from Rensselaer as an IBM Ph.D. Resident Fellow and has been awarded multiple patents in signal processing and recognition systems. Dr. Gozzo was an adjunct faculty member at the State University of New York, guest lecturer at Duke University and invited strategic advisor to organizations including the White House – Office of the President, diverse Federal agencies and private equity firms. He is a Fellow of the National Association of Corporate Directors (NACD), SEC-qualified audit committee financial expert and has held board positions in organizations including Bell & Howell, Noverant, Ravenscroft and Make-A-Wish.

About ISPE Carolina-South Atlantic
ISPE Carolina-South Atlantic Chapter is a society of technical professionals who apply their practical knowledge in the regulated pharmaceutical and medical device manufacturing industries. The group is committed to the advancement of the educational and technical efficiency of its members through forums for the exchange of ideas and practical experience. ISPE Carolina-South Atlantic is one of the largest of ISPE’s more than 30 North American Chapters and worldwide Affiliates. For more information, visit www.ispe-casa.org.

About Noverant
Noverant is a leader in web-based information, training and compliance management applications, serving regulated and training-intensive clients on six continents. For more information, visit www.noverant.com.

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Noverant Guidance for Part 145 Repair Stations – Preparing For New TSA Security Requirements

The United States Transportation Security Administration (TSA) has released new security requirements for Part 145 repair stations under a new section titled 49 CFR 1554 – Aircraft Repair Station Security. Noverant has completed a review of the new code and summarized key points for repair stations.

Summary of 49 CFR 1554

The requirement imposes security-related process, documentation and record keeping requirements on all Part 145 repair stations. Particular focus is given to those stations serving large aircraft (12,500 lbs) or operating on/near airports with established airport security programs per 49 CFR part 1542 or equivalent foreign airports. Note that the regulation is not applicable to repair stations that are located on U.S. or foreign military installations.

Part 145 Repair Stations (US Locations)

All Part 145 repair stations must allow TSA and other authorized DHS officials, at any time and in a reasonable manner, without advance notice, to enter, conduct any audits, assessments, or inspections of any property, facilities, equipment, and operations; and to view, inspect, and copy particular records as necessary to carry out TSA’s security-related statutory or regulatory authorities.

Part 145 repair stations serving large aircraft or on/near airports governed by an airport security program must also provide TSA with the name and means of contact, on a 24-hour basis, of a person or persons designated by the repair station as the primary security point of contact with responsibility for overall security compliance to 49 CFR 1554 and communications with TSA.

In addition, these stations must maintain accurate records for those employees with access to large aircraft; develop documented key control, aircraft access and related procedures; and maintain appropriate records for evidence of compliance. In addition, specific background checks for various individuals are required and documented procedures must be implemented to receive, protect and respond to TSA-issued security directives.

Part 145 Repair Stations (Non-US Locations)

Part 145 repair stations based outside the United States must abide by the same requirements, including documented evidence of compliance, as US-based stations. Further, all records must be provided in English upon TSA’s request.

Recommendations

Repair stations should carefully develop an efficient program to address the new requirements as soon as possible. In most cases, particularly for stations conducting business in English, compliance will not be a major burden after the security program is initially established and an efficient compliance management system is in place. However, Noverant cautions repair stations that compliance and enforcement of these new security rules should be taken seriously and requires immediate attention. According to the new TSA requirement, a repair station may be subject to suspension of its FAA certificate if security deficiencies are identified and are not corrected in a timely fashion.

Noverant is approved by TSA for the storage of Security Sensitive Information (SSI) and has developed applicable standard operating procedures (SOPs) to address 49 CFR 1554. Repair stations are encouraged to contact Noverant to discuss  customization of these SOPs for their particular need.

About Noverant

Noverant is a leader in web-based information, training and compliance management applications, serving regulated and training-intensive clients on six continents. For more information, contact Noverant.

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Noverant CEO Frank Gozzo Appointed NACD Fellow

WASHINGTON — The National Association of Corporate Directors (NACD) is pleased to announce that Noverant president and CEO Francesco “Frank” Gozzo of Raleigh, NC has become an NACD Fellow, the highest level of credentialing for corporate directors and corporate governance professionals. Gozzo currently serves on the boards of Noverant, FlightGest and Make-A-Wish of Eastern North Carolina and has served on diverse boards in for-profit and non-profit sectors throughout his career.

As an NACD Fellow, Gozzo has demonstrated his knowledge of the leading trends and practices that define exemplary corporate governance today. “I am honored to join the distinguished and diverse group of NACD Fellows who have committed to advancing the highest standards of boardroom leadership,” said Gozzo. “The resources, insights and connections I’ve made through NACD’s Fellowship program will be key assets to the companies I serve.”

“We are proud to announce that Dr. Gozzo has joined NACD’s credentialed directors,” said Ken Daly, president and CEO of NACD. NACD’s Fellows serve on boards of some of the largest and most diverse corporations in the world. “Our fellows help advance the highest standards for those who serve in the boardroom, strengthening our businesses and driving director professionalism.”

About NACD
The National Association of Corporate Directors (NACD) is the only membership organization focused exclusively on advancing exemplary board leadership. For more information, visit www.NACDonline.org

About Noverant
Noverant is a leader in web-based information, training and compliance management applications, serving regulated and training-intensive clients on six continents. For more information, visit www.noverant.com.

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Noverant Selects Sequence, Inc. as a Life Science Channel Partner

Raleigh, NC – Noverant is pleased to announce that it has selected Sequence, Inc. as a major channel partner. Under the non-exclusive, long term agreement, Sequence will lead the sales, marketing and account management efforts in a number of markets, initially focused on pharmaceutical, biotech, and medical device industries.

Commenting on the major alliance, Dr. Frank Gozzo, president and CEO of Noverant stated, “Noverant has enjoyed 6 consecutive years of strategic growth and is now prepared to take our unique services to the next level through qualified channel partners. Sequence has highly-qualified subject matter experts who work on-site with diverse clients in the life science industry, and so the synergy of their consultants with our technology makes good business sense.”

Michael Putnam, president and CEO of Sequence stated, “With over 11 years of hands-on experience in the life science industry, we have a keen awareness of the operational needs of our clients. After careful due diligence, we selected Noverant for their proven technology, genuine customer-driven approach and unique ability to provide a highly-scalable, device-independent information, training and compliance management platform.

About Sequence
Sequence is a leader in providing quality and compliance consulting services to the Pharmaceutical, Biotech, and other regulated industries. For more information, visit www.sequencevalidation.com.

About Noverant
Noverant is a leader in web-based information, training and compliance management applications, serving regulated and training-intensive clients on six continents. For more information, visit www.noverant.com.

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AAMRO Provides MRO Recertification Examination via iPad Using Noverant’s Learning Management System

RALEIGH, NC – The American Association of Medical Review Officers (AAMRO) has recently completed its upgrade to Noverant Online Enterprise 3, which allows physicians to complete their recertification exams on virtually any computing device, including iPad and other smart devices.

Commenting on the new release, Ted Shults, AAMRO founder stated: “Physicians have quickly adapted to new computing technologies such as iPads and other smart devices. Giving them the ability to securely complete the recertification process from any device provides much needed flexibility.”

Noverant’s new release provides unprecedented functionality and flexibility to regulated and training-intensive clients. Commenting on the robust technology, Jim Tringas, VP Global Marketing stated: “Gone are the days where a vendor can sit back and focus on just one device/browser combination. Our customers and regulators asked for device independence, and we delivered.”

Noverant Online is available immediately under a free 60-day trial. For more information or to begin your free trial on an iPad or other device, contact Noverant at http://www.noverant.com/contact.

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Noverant Completes Validation of Enterprise 3 Service for Life Science and Pharmaceutical Industries

RALEIGH, NC – Noverant, a leading provider of information, training and compliance management services for FDA-regulated companies, completed formal validation of its latest web-based learning management system. The validation enables existing and new clients to shift to Noverant’s industry-leading service while minimizing the burden associated with traditional 21 CFR 11 validation efforts.

Software validation requires a rigorous sequence of tests including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) that consume significant resources any time a system is upgraded. Noverant has successfully completed the full validation of the newest release in the company’s QA-controlled environment which is hosted in Noverant’s state-of-the-art data center. The validation provides the required core documentation that demonstrates evidence of compliance to system specifications and 21 CFR 11.

Once validation is complete in Noverant’s environment, Noverant then works with individual clients to effectively transfer the documented OQ testing results in an efficient, FDA-approved framework to the client’s dedicated instance.

Noverant offers its service for FDA-regulated industries in a variety of deployment options, ranging from dedicated on-site installations to private cloud instances administered by Noverant. Commenting on the recent validation, Jim Tringas, VP of Global Marketing at Noverant stated: “Noverant Online Enterprise 3 brings unprecedented functionality including incredible learner usability, real-time analytics, an advanced reporting engine and universal mobile access. Completing the validation process enables our life science clients to take advantage of the rich new user interface while easily adhering to 21 CFR 11 standards.”

Noverant Online Enterprise 3 is currently used in a wide variety of industries on six continents for clients ranging from small physician offices to international pharmaceutical giants.

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Noverant Learning Management System Now iPad-Compatible

RALEIGH, NC – Noverant is pleased to announce that the latest release of their learning management system, Noverant Online Enterprise 3, has been deployed worldwide and client feedback regarding the new device-independent design is outstanding. The latest upgrade, which includes many new features including industry-first performance and financial analytics, is now available on any computing device including standard computers, laptops, tablets, iPads and smartphones.

Commenting on the major release, Jim Tringas, VP of Global Marketing stated: “Noverant serves clients on six continents, and so we have unique experience with virtually every combination of hardware, operating system and browser.”

Noverant’s customer-driven Technology Advisory Board provided a clear message that device independence was a top priority, and so it was a key driver in Noverant’s latest release. Further commenting, Tringas stated: “The eclectic mix of our user base is a testament to our robust technology and ability to handle truly blended learning environments. Whether it’s a physician completing a certification exam on an iPad in the United States, a quality engineer conducting an internal SOP audit in Europe in a corporate setting, or a manager reviewing board governance material on antiquated technology in Asia – our system provides an outstanding user experience.

Noverant Online is available immediately under a free 60-day trial. For more information or to begin your free trial, contact Noverant at http://www.noverant.com/contact.

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Bullwheel Productions Selects Noverant As E-Learning Platform For Ski Industry

RALEIGH, N.C. – Noverant announced today that Bullwheel Productions has selected Noverant as their learning management system platform to address the needs of the ski and resort industry.

Commenting on the award, Jim Tringas, vice president of global marketing stated: “Noverant has consistently proven to be a genuine partner for content providers looking to scale their business. We’re confident that our platform will enhance Bullwheel’s outstanding training material for the ski and resort industry.

James Dubendorf, president of Bullwheel Productions, stated: “All season long, ski resorts face continuous staffing and training challenges. Bullwheel helps resorts meet these challenges with engaging and effective video-based training. Our partnership with Noverant has allowed us to quickly scale to serving ski and resort industries worldwide.”

ABOUT NOVERANT, INC.:

Noverant, Inc. is a global leader providing web-based information, training and compliance management services and custom solutions that meet the regulatory needs of public, private, profit and nonprofit organizations. The firm can satisfy 100 percent of an organization’s training, licensing, compliance and auditing requirements, including those monitored by agencies such as the FDA, FAA, SEC, DOT, TSA, OSHA and others. With scalable solutions for organizations of any size, Noverant automates all types of learning and compliance including revision-controlled standard operating procedures (SOPs), instructor-led courses, web-based training (WBT), comprehension assessments and analytics. For more information, visit http://www.noverant.com.

ABOUT BULLWHEEL PRODUCTIONS

Bullwheel Productions provides innovative training and management solutions for the ski and resort industries. For more information, visit http://bullwheelproductions.com

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FAA Approves Use of Noverant Online For Part 141 Flight Schools

RALEIGH, N.C. – The Federal Aviation Administration (FAA) has approved the use of Noverant Online for electronic compliance management and recordkeeping of critical records required by Part 141 flight operations. The approval includes the full range of documentation for students and instructors including enrollment certificates; training course outlines; ground and flight lesson tracking; aircraft checklists and operating procedures; knowledge tests; stage checks and graduation certificates. The service provides flight schools with the ability to significantly reduce cost, enhance training effectiveness and further standardize and streamline operations by allowing for single source access to all documentation, training and certifications.

Gone are the days of CFIs having to rummage through cabinets, refer to spreadsheets or file folders. With any browser on a computer, iPad, smart phone or other device, they can have it all at their fingertips.”

Commenting on the announcement, Jim Tringas, vice president of global marketing, stated: “Noverant is the first learning management system accepted by the FAA which meets strict 21CFR11 requirements. It greatly simplifies the information, training, compliance and recordkeeping of any Part 141 operation. We’ve had strong success with air carriers (Part 121/135) and airport authorities (Part 139) and we’re excited about this new offering for flight schools operating under Part 61 or Part 141.”

In addition to eliminating the need to store paper records, the secure service greatly simplifies the compliance management function for operators and streamlines FAA inspections. Tringas stated further: “Our web-based service works with any curriculum, whether designed internally by the flight school or provided by any popular 141 training provider such as Cessna, Sporty’s, Jeppesen, Gleim or others. The service also provides real-time compliance management with unprecedented analytics which allow training administrators to easily measure training effectiveness and make course improvements as necessary.

Noverant Online is available immediately under a free 60-day trial to any existing or prospective Part 141 flight school. For more information or to begin your free trial, contact Noverant at http://www.noverant.com/contact.

ABOUT NOVERANT:
Noverant is a global leader providing web-based information, training and compliance management services and custom solutions that conform to regulatory agency requirements for public, private, profit and nonprofit organizations. The firm can satisfy 100 percent of an organization’s training, licensing, compliance and audit requirements, including those monitored by agencies such as the FDA, FAA, SEC, DOT, TSA and others. With scalable solutions for organizations of any size, Noverant automates all types of learning and compliance reporting, including standard operating procedures (SOPs), instructor-led courses, web-based training, comprehension assessments and performance evaluations. For more information, call Jim Tringas at (919) 825-5613 or visit http://www.noverant.com.

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FAA Approves Use of Noverant Online For Air Carrier Electronic Recordkeeping and Compliance Management

RALEIGH, N.C. – The Federal Aviation Administration (FAA) has approved the use of Noverant Online by air carriers for electronic compliance management and recordkeeping of critical records. The approval includes flight crew records such as flight and duty time logs, documents required by the Pilot Records Information Act of 1986 (PRIA), drug/alcohol program records required by 14 CFR 120 and 49 CFR 40, and revision/distribution control of key documents including operating manuals, safety management systems, standard operating procedures and operations specifications. The approval provides air carriers and inspectors with the ability to significantly reduce cost, enhance compliance and streamline reporting requirements.

Commenting on the announcement, Jim Tringas, vice president of global marketing, stated: “Noverant is the first web-based learning management system accepted by the FAA which meets strict 21CFR11 requirements. It greatly simplifies the information, training and compliance management functions of an air carrier and also makes the FAA’s job much easier. We’re excited about the FAA’s approval and look forward to working with operators and inspectors on its broad deployment.”

In addition to eliminating virtually all paper records, the service greatly simplifies the compliance management function for operators and streamlines FAA inspections. Whether used independently or in conjunction with any industry audit, Noverant Online is the only service which provides real-time compliance management and secure transparency required by the FAA.

Tringas further stated, “From crewmembers using an iPad to management working from a laptop to an inspector using a smart phone in the field during a ramp check … the service will truly revolutionize operations for any size flight or maintenance operation.”

Noverant Online is available immediately under a 60-day free trial to any regulated air carrier, fractional provider or corporate flight department of any size.

ABOUT NOVERANT:
Noverant is a global leader providing web-based information, training and compliance management services and custom solutions that conform to regulatory agency requirements for public, private, profit and nonprofit organizations. The firm can satisfy 100 percent of an organization’s training, licensing, compliance and audit requirements, including those monitored by agencies such as the FDA, FAA, SEC, DOT, TSA and others. With scalable solutions for organizations of any size, Noverant automates all types of learning and compliance reporting, including standard operating procedures (SOPs), instructor-led courses, web-based training, comprehension assessments and performance evaluations. For more information, call Jim Tringas at (919) 825-5613 or visit http://www.noverant.com.

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