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Companies struggling to comply with the FDA’s myriad electronic recordkeeping regulations should take a deep breath and follow it up with a long, careful look at the FDA’s actual GxP and 21 CFR Part 11 rules. After a careful reading of the admittedly long and sometimes dry rules, it should become…
An upcoming conference focusing on stability testing will feature several major pharmaceutical and biotechnology companies. The “Advances and Efficiencies in Stability Testing for the Pharmaceutical & BioTech Industry” conference will be held March 7–8 at the La Jolla Marriott in San Diego. It…
The 6th annual Market Development & Outreach Multicultural Pharmaceutical Conference will be held March 17–18 in Iselin, New Jersey.The event is intended for pharmaceutical and health care companies that produce or develop products for diabetes, heart disease, cancer, HIV/AIDS, hepatitis and…
The Regulatory Compliance Workshop Group will present the 2005 Pharma IT Compliance Week training event March 7–11, in Puerto Rico. The event will feature five one-day workshops, with topics including “Auditing Computerized Systems to Pass FDA and European Regulatory Standards,” “Understanding and…
PTI International Inc., an accredited provider of online continuing pharmaceutical education, will offer several upcoming courses on compliance to 21 CFR Part 11. The course, “How to Develop and Implement Risk-Based Strategies,” is designed to help attendees improve compliance with regulatory…
Purdue Pharma recently started to integrate radio frequency identification (RFID) tags into its packaging to prevent drug counterfeiting.The company will use RFID products produced by Symbol Technologies Inc. for the pilot project, which began with the RFID tagging of 100-count bottles of OxyContin…
Thomson Scientific & Healthcare Corp., a provider of integrated information products for the health care industry, recently introduced a new pharmaceutical product labeling solution that complies with impending FDA regulations. Thomson is now offering outsourced label conversion using its…
The Malcolm Baldrige National Quality Award program will receive its 1,000th application in 2005, a milestone award administrators will celebrate all year long. Between 1998 and 2004, there have been 343 manufacturing applications (25 award recipients), 164 service applicants (13 recipients), 326…
AssurX Inc., a supplier of enterprise quality and compliance systems, recently introduced CATSWeb Records Management, a solution designed to assist companies in complying with corporate record retention policies. Recent high-profile corporate compliance scandals have made record retention more…
More than 1,000 health care quality experts will meet in San Francisco this week for the annual meeting of the American Health Care Quality Association.The two-day event starts Feb. 23 at the Hyatt Regency Embarcadero. It will feature keynote addresses from Don Berwick, president and CEO of the…
A new study from Best Practices LLC shows that the best performance management and measurement tactics not only affect the bottom line, but also significantly enhance employee satisfaction. Companies that heavily invest in their employees reap the rewards of their investment. Some examples include…
QualityWBT Center for Education and AQS Management Systems Inc. have partnered to offer a new ISO 9001 certified lead auditor class over the Internet. The RABQSA-approved class combines three days of training online and two days of face-to-face training. Students can access the online training at…
The International Organization for Standardization recently launched an online survey to examine the value of ISO 14001 to small and medium-sized businesses. ISO encourages all sm all- to medium-sized businesses to participate, whether or not they have implemented ISO 14001 or another environmental…
The National Committee for Quality Assurance recently praised the Centers for Medicare and Medicaid services for launching a new pay-for-quality pilot project designed to demonstrate the effectiveness of the approach in large medical groups. The 10 large medical groups participating in the program…
The headlines screamed, “Local Hospital Leads the State in C-Sections!” The gist of the story was that this hospital had more cesarean section births than any other hospital in the state. Indeed, it had led the entire Southwestern region for five years running. It’s well-established that C-…
The Canadian Parliament will provide nearly $1 million to train companies in the rural Northumberland region in quality improvement skills. The skills development support will be funded by the Eastern Ontario Development Fund, a $10 million initiative designed to support economic renewal in eastern…
Corporation Bank of India recently completed a Six Sigma project to make its business processes and operations more efficient. Wipro Infotech facilitated the project, which started in June 2004. Along with improving its internal processes, the project installed a culture of continual improvement at…
The U.S. Navy plans to expand training of its Naval Air Systems Command (NAVAIR) sector in Six Sigma, kaizen, lean and theory of constraints. The training program will take place at Depot North Island, in California. NAVAIR has already trained 18 teams in more than two years and now plans to train…
PowerSteering CEO David Boghossian and Pitney Bowes Vice President of Six Sigma Nancy Tan recently addressed a Six Sigma summit in Miami. Titled “Using Six Sigma to Assess and Overcome Gaps in Performance,” the discussion focused on using the methodology to improve internal processes and customer…
SBTI recently named Debby Sollenberger as its vice president of business development. Sollenberger has significant experience with Six Sigma. She is a Master Black Belt who led Six Sigma initiatives at GE’s aircraft engines sector and has trained more than 6,000 employees, 900 Black Belts and 60…
ValueCurve Technologies Inc. recently released version 2.0 of its ValueDriver4 project performance management suite. The software provides a standardized process for justifying ERP, Six Sigma, new software development, and research and development projects to management. It includes project risk…
The American Society for Quality has teamed with two health care quality organizations to sponsor a conference examining the role of quality in health care. ASQ has joined with the American Hospital Association and the American Society for Healthcare Risk Management to develop the conference, which…
FeinFocus recently opened a new office in Shanghai to provide sales and technical support to the growing Asian market. The new office will operate as part of the newly expanded COMET China office, to offer a complete X-ray solution combining the conventional X-ray expertise of COMET with the…
IQS Inc. recently released a new JAVA-based supplier managed capability that gives suppliers direct access to the corrective action requests they have been assigned. The new capability is designed to enhance collaboration, communication and accuracy. It allows users to login to specified portions…
Metris USA recently opened its new Michigan Technology Center, the latest phase in the metrology company’s $2 million expansion. The new center houses two coordinate measuring machines and other items for customer demonstrations. The company plans to use the facility for training and education for…
