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A Blueprint for Electronic Record Retention
Tamar June
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…
Pharmaceutical Stability Testing Conference Planned
Quality Digest
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…
Multicultural Pharmaceutical Conference Announced
Quality Digest
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…
2005 Pharma IT Compliance Week to be Held in Puerto Rico
Quality Digest
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…
21 CFR Part 11 Compliance Courses Offered
Quality Digest
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 Employs RFID Into Packaging to Prevent Counterfeiting
Quality Digest
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…
NCQA Lauds New Federal Pay-for-Quality Pilot Project
Quality Digest
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…
2005: Year of the 1,000th Baldrige Applicant
Quality Digest
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 Introduces Records Management Software
Quality Digest
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…
Health Care Quality Experts to Meet in San Francisco
Quality Digest
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…
Satisfied Employees Equal Strong Companies
Quality Digest
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…
ISO 9001 Lead Auditor Training Available on Internet
Quality Digest
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…
Online ISO 14001 Survey for Small Businesses Now Available
Quality Digest
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…
SBTI Names New VP of Business Development
Quality Digest
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…
How to Lead With Six Sigma
Tom Pyzdek
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-…
ValueCurve Technologies Releases Updated Software
Quality Digest
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…
Canadian Government to Train Rural Companies in Six Sigma, Related Skills
Quality Digest
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 Finishes Six Sigma Project
Quality Digest
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…
Military Trains Staff in Six Sigma, Lean
Quality Digest
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 Addresses Six Sigma Summit
Quality Digest
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…
Study: Few Health Care Organizations Have ’Crossed the Quality Chasm’
Quality Digest
A new study shows that most health care providers support the idea of improving the quality of their services, but few have adopted initiatives to do it. The study, performed by health care quality organization URAC, sought to discover how medical management organizations have responded to a 2001…
WESTEC Conference Dates Approaching
Quality Digest
More than 20,000 people are expected to attend the WESTEC 2005 exposition and conference, which will be held April 4–7 at the Los Angeles Convention Center. The event is one of the 200 largest trade shows in North America, attracting large numbers of domestic and international manufacturers…
ASQ Co-Sponsors Health Care Quality Conference
Quality Digest
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…
New Judges Appointed to Baldrige Panel
Quality Digest
Former U.S. Secretary of Commerce Donald Evans recently appointed four prominent industry leaders to the Malcolm Baldrige National Quality Award panel of judges.The new judges are Lloyd Barker, Alcoa Inc. director of corporate quality; David C. Branch, Branch-Smith Resources Ltd. chairman and CEO;…
FeinFocus Opens New Office in China
Quality Digest
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…

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