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By: Quality Digest

The Food and Drug Administration has determined that endoscopic trocars reprocessed by Vanguard Medical Concepts Inc. are substantially equivalent to new instruments and has cleared the company to resume selling them. Vanguard voluntary took its trocars off the market last fall, pending an FDA request for additional documentation of Vanguard’s methods for cleaning, testing and sterilizing the costly devices. At issue was whether the trocars, which are marketed for single use, could be safety reconditioned for a limited number of additional uses and function as new without patient health risks.

“We have always held ourselves to the most stringent cleaning, testing and sterilization standards,” says Charles Masek, president and CEO of Vanguard. “With today’s announcement, we have completed an unprecedented second round of intense regulatory scrutiny and passed with flying colors.”

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By: Quality Digest

As the nation tightens its borders against possible terrorist attacks, it risks undermining those efforts by allowing the importation of non-FDA-approved prescription drugs. This was the conclusion of a report issued by Giuliani Partners, a firm headed by former New York City Mayor Rudy Giuliani. “Examination and Assessment of Prescription Drug Importation from Foreign Sources to the United States” was commissioned by the Pharmaceutical Research and Manufacturers of America. The report found that the risk of importing drugs far outweighs any benefits and calls on the Department of Homeland Security to conduct a threat and vulnerability assessment.

“We should not contemplate opening our borders to threats to our medicine supply when in all other aspects we’re searching for ways to tighten the security of our borders,” says Giuliani in the report. “Several credible sources have identified links between counterfeit good, including pharmaceuticals, and organized criminals and terrorist groups. It isn’t difficult to imagine a scenario in which terrorist groups could use this system to either finance operations or, worse, as a vehicle of attack.”

Key findings of the report include:

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By: Quality Digest

Firstlogic Inc., a provider of enterprise information quality and mail-automation software, recently announced that Dendrite International has started using its data quality solutions to improve customer information management for Dendrite’s pharmaceutical and life sciences clients. Dendrite is a provider of sales, marketing, clinical and compliance solutions to the life sciences and pharmaceutical markets. It’s using Firstlogic’s Information Quality Suite to validate and cleanse data about the end-user physicians that prescribe medications. The software also allows Dendrite to help pharmaceutical manufacturers in their promotion and marketing efforts.

“Dendrite strives for technological innovation in developing leading-edge solutions to drive sales and marketing effectiveness in the global pharmaceutical industry,” says Daniel Ballard, vice president of Dendrite. “Part of that expertise is finding the technologies we can easily integrate to better serve out customers, and Firstlogic reputation of achievement in their space is outstanding.”

For more information, visit www.dendrite.com or www.firstlogic.com.

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By: Thomas Erbach, Lisa Fan and Shari Kraber

Optimizing biological assay conditions is a demanding process that scientists face every day. The requirement is to develop high-quality, robust assays that work across a wide range of biological conditions. The demand is to do this within a short development time frame. To overcome these obstacles, automated systems are often required to accommodate large numbers of samples. Setting up a model that systematically studies key experimental parameters, each across a defined range, is a challenge. Traditionally, one-factor-at-a-time (OFAT) testing studies individual experimental conditions, but this approach is time-consuming and tedious. More important, measuring how the change of one single factor affects the assay leaves the experimenter blind to interactions that may exist between two or more experimental factors. The information lost in OFAT designs may significantly reduce assay quality and robustness.

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By: ISPE

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) announced the availability of its newest technical publication, “GAMP Good Practices Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.” The guide is a user-friendly manual that covers the appropriate management of electronic records and signatures. It’s the newest edition to ISPE’s GAMP Good Practice Guide Series, developed by the GAMP Forum, a technical subcommittee of ISPE. It supplements the existing “Good Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture—GAMP 4.”

The main section of the guide provides a process by which a regulated company can identify the hazards associated with the use of electronic records and signatures, analyze and evaluate risks, control risks, and monitor the effectiveness of the controls via periodic review.

For more information, visit www.ispe.org.

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By: Quality Digest

Sypris Test & Measurement Inc. has added electromagnetic interference (EMI) and electromagnetic conformance (EMC) testing capabilities to its offerings. The services are available in Sypris’ facilities in Burlington and North Billerica, Massachusetts; and Wayne, New Jersey. The company reached an agreement with Quest Engineering, in which Sypris will perform EMI and EMC testing for Quest in its North Billerica facility. Quest Engineering will perform air lab, audio and product safety testing.

“These additions demonstrate our continued commitment to providing our customers with the broadest-possible base of experience and testing capability, and enhance our presence in the northeast,” says John Baron, Sypris director of testing operations. “Sypris is a market leader in the testing of semiconductor components, and military and commercial product compliance testing.”

For more information, visit www.wetest.com.

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By: Quality Digest

SRI Quality System Registrar has a new president and chief operating officer, Greg Swan. Swan has more than 30 years experience in quality management, 15 in auditing and certifying management systems. He’s the former president of Bureau Veritas Quality International North America Inc. and the founder and past president of the Independent Association of Accredited Registrars. Swan holds a degree in psychology from the State University of New York and was a submariner in the U.S. Navy.

“I’m excited about the opportunity to get involved with an innovative, growing company in this increasingly competitive market,” Swan says. “SRI has industry-leading auditors and staff, an unquestionable reputation and strong relationships with its clients and the quality industry that underpins its success.”

“I’m pleased that Greg, a longtime friend and associate, has agreed to help lead SRI through this time of domestic and international growth,” says Peter B. Lake, CEO and founder of SRI. “His strategic thinking and operational experience will be invaluable in building an organization that can meet the needs of our increasing client base.”

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By: Quality Digest

Metris, a provider of laser-based scanning applications, recently announced the simultaneous acquisition of Krypton N.V., of Belgium; and MetricVision, a Washington-based company. Krypton develops and produces quality control and testing solutions based on linear camera technology. MetricVision develops and manufactures precision 3-D measurement laser radars based on its patented coherent laser radar technology. Bart Van Coppenolle, Metris president and CEO, reports that the acquisitions will position the company to lead the optical metrology market.

“The synergies in our respective customer bases, product mix and organizational structures will further drive our rapid growth,” Van Coppenolle says. “The Krypton and MetricVision products are also fully complementary with our existing CMM OEM distribution network.”

“This is an exciting time for all the stakeholders associated with MetricVision,” says Tom Bouchard, MetricVision’s former CEO. “Being an integral part of the dynamic Metris team will maximize the value and opportunities we can deliver to our customers, employees, shareholders and business partners.”

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By: Quality Digest

The first Lean Accounting Summit will take place Sept. 22–23 in Dearborn, Michigan. The event, planned to take place annually, will feature more than 20 leaders in the lean accounting sector. Presenters include Tom Johnson, professor of business administration at Portland State University; Brian Maskell, president of BMA Inc.; and Orry Flume, 2004 Shingo Prize-winning author of Real Numbers: Management Accounting in a Lean Organization.

“We’re trying to spark a long-overdue, but needed, revolution in accounting,” says Jim Huntzinger, master guide for Flexware Innovation Inc. and event organizer. “We hope to foster an understanding of what needs to take place and why.” Huntzinger has been involved in lean implementations for more than 16 years and says the transition won’t be quick. He hopes the annual gathering will bring more interest in lean accounting.

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By: Quality Digest

Organizers of the 12th annual International Research Seminar are seeking paper proposals for presentation. The seminar will be held Feb. 13–14, 2006, in New York City. The event is being sponsored by the W. Edwards Deming Institute and Fordham University. Papers that link Deming’s work to the academic literature or works of other great thinkers are particularly sought, as are papers that extend or expand Deming’s work, and those that describe applications of his management ideas.

The annual seminar brings together people from around the world, from a variety of specialties, to develop a better understanding of Deming’s theories in a wide-ranging context. To be considered, paper proposals must be original. works of 200 words and should be e-mailed to wedresearch@fordham.edu by Oct. 3.