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Senator Grassley Questions FDA Drug Safety
Sen. Chuck Grassley Press Office
(Washington, D.C.) — Republican senator Chuck Grassley of Iowa has asked for an independent assessment of how the Food and Drug Administration (FDA) follows up on the effects of medicines that it approves based on narrowly defined benefits.“The way things have turned out with drugs like…
Zimmer Recalls Patient Care Product Lines
Zimmer Holdings Inc.
(Zimmer Holdings Inc.: Warsaw, Indiana) -- Zimmer Holdings Inc. has recently taken a number of actions to improve quality systems at its Dover, Ohio, facility, which manufactures Zimmer Orthopedic Surgical Products (OSP). Zimmer recently conducted a review of quality systems at the Dover, Ohio…
Essential Elements of Effective CAPA Systems
Ken Peterson
From the perspective of the U.S. Food and Drug Administration and other regulatory agencies, corrective and preventive action (CAPA) is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change controls,…
CRO Completes Multinational Training Program for Principal Investigators from China, Duke University
Clinical Research Consulting Inc.
Lisa Mazurka and the clinical investigators involved in the training is available (Clinical Research Consulting Inc.: Boston, Massachusetts) -- Clinical Research Consulting Inc., a contract research organization (CRO) specializing in clinical monitoring, project management, education and…
QPEC Annual Quality and Process Excellence Conference
Pharmaceutical Technology Magazine
(Pharmaceutical Technology Magazine: Iselin, New Jersey) – QPEC’s Annual Quality and Process Excellence Conference will be held from July 21-23 at the Westin Arlington Gateway in Arlington, Virginia. The conference is sponsored by Pharmaceutical Technology Magazine. This case study-driven…
Compliance to Regulations, PAT Initiative Remain Top Market Drivers in European Market
(Research and Markets: Dublin, Ireland) – A Frost & Sullivan research service titled “Automation and Control Solutions in the European Pharmaceutical Market” provides an analysis of the various factors driving and restraining the market, revenue forecasts, geographic trends and…
Minnesota Quality Awards
the Minnesota Council for Quality
(MCQ: Minnetonka, Minnesota) -- The Minnesota Council for Quality recently announced the recipients of the 2007 Minnesota Quality Award. Nine organizations received recognition this year: • Achievement Level o Winona Health (Winona) • Advancement Level o Benedictine Health System, Long-Term…
ISO 9001:2009 Conference
(ISO: Geneva) -- Organized in association with ASQ, the International Conference on ISO 9001 will occur March 9 and 10, 2009, in Orlando, Florida, with workshops held on March 8.The 2009 conference theme is ISO 9001 and ISO 9004 revisions. The deadline for submitting an abstract is August 29, 2008…
Measurement-Language Guide Updated
ISO
(ISO: Geneva) -- ISO recently published a new version of the SI Guide, a small manual for the use of the International System of Units (SI [Système International d’Unités]).The SI is a comprehensive metric and decimal system based on units and derived units. The seven base units are length, mass,…
An Effective Safety Program
David A. Marshall
Not long ago many manufacturing companies considered accidents and the resulting costs part of the expense of doing business. Today’s companies are creating better safety programs that benefit the financial health of the organization and significantly improve the protection provided to individuals…
Show Me the Money
Steven Ouellette
If you have been following my articles for the last few months, you know that we’re almost done with an experimental analysis and that today we will be doing the final step—making our company money. If you haven’t been following my articles, then you should probably be flogged with a soggy…
2008 International Forum on DFMA
Boothroyd Dewhurst Inc.
(Boothroyd Dewhurst Inc.: Wakefield, Rhode Island) -- Boothroyd Dewhurst Inc. will host the 23rd annual International Forum on design for manufacture and assembly (DFMA), on June 10-11, 2008. The forum, titled “DFMA Today: Leading the Way to Results,” will take place at the Crowne Plaza Hotel,…
Providing an Aggregate View of Six Sigma Projects
Minitab LLC
(Minitab Inc.: State College, Pennsylvania) -- Minitab Inc. has released the Quality Companion Dashboard, a tool for users of Quality Companion by Minitab. The Dashboard is a complimentary utility that aggregates project data and lets Six Sigma professionals, managers, and stakeholders view…
Kids, Kats, and Six Sigma
Lucky Kat TV
(Lucky Kat TV: Los Angeles) -- Corporate America is filled with busy parents wanting to deliver every possible advantage to their children while still climbing the career ladder. With the help of Mikel Harry and a 400-year-old Asian legend, these overachievers can give their loved ones a child-…
ISO/IEC DIS 29500 Becomes an International Standard
(ISO: Geneva) -- ISO/IEC DIS 29500—“Information technology—Office Open XML file formats,” has received the necessary number of votes for approval as an ISO/IEC DIS international standard. ISO/IEC DIS 29500 is a standard for word-processing documents, presentations, and spreadsheets that’s intended…
Changing to Lean, Part 3
Mike Thelen
Mark Graban, consultant and host of www.leanblog.org , and a good lean friend, once posted a web log topic on “lean or lame” (a phrase he coined). That topic drew a variety of comments from his readership. He described L.A.M.E. as “lean as misguidedly executed,” and it’s his description that so…
Airline Industry Score Falls To New Low
Airline Quality Rating
(AQR: Washington) -- Air Tran has taken the top spot in the 18th annual national Airline Quality Rating study. Last year, Air Tran ranked third in the AQR. Following Air Tran in the top five of the AQR were Jet Blue, Southwest, Northwest, and Frontier. As for the overall rating for the industry,…
Changing to Lean, Part 3
Mike Thelen
Mark Graban, consultant and host of www.leanblog.org , and a good lean friend, once posted a web log topic on “lean or lame” (a phrase he coined). That topic drew a variety of comments from his readership. He described L.A.M.E. as “lean as misguidedly executed,” and it’s his description that so…
ISO To Develop Standard for Energy Management
(ISO: Geneva) -- The International Organization for Standardization recently approved the development of an international standard on energy management. The standard will provide organizations and companies a practical and widely recognized approach to increase energy efficiency, reduce costs, and…
Microstamping Analysis Enhanced By Confocal Microscopy
Olympus
This image shows how a microstamped primer on a cartridge casing is visualized using the Olympus LEXT platform. The image highlights the benefits of analysis and visualization using Confocal microscopy. Seen here are increases in resolution, depth of focus and contrast…
The GD&T Encoding Process
William Tandler
T he actual purpose of GD&T: It’s common to think that the primary purpose of GD&T is to unambiguously communicate design intent to manufacturing and inspection. In fact, the most important objective is to ensure that what we communicate is worth communicating, and that it…
24th Coordinate Metrology Systems Conference
Coordinate Metrology Society CMS
(Coordinate Metrology Society: Concord, North Carolina) -- The Coordinate Metrology Society, a membership association for measurement professionals, will host its 24th Annual Coordinate Metrology Systems Conference (CMSC) 2008 from July 21–25, 2008 at the new Embassy Suites overlooking Lowes…
Tracking Nanoparticles in 3-D
NIST
Heart of the orthogonal tracking microscope system developed at NIST is this nanoparticle solution sample well etched in silicon. Careful orientation of the silicon crystal makes it possible to chemically etch angled sides in the well so smooth they act as mirrors. In this…
The Farmer and the Stork
Denise Robitaille
A farmer was experiencing a serious problem with cranes eating his seed, so he decided to cast a net upon his fields in an attempt to capture the cranes. Along with the cranes, he snared a stork. The stork pleaded for his life saying, "Honorable farmer, I am not like these others who came to steal…
OSHA Seeks Comments on VVP Information Collection Procedures
OSHA
(OSHA: New York) -- The Occupational Safety and Health Administration (OSHA) is requesting public comment on proposed information collection requirements for the Voluntary Protection Programs (VPP). Established in 1982 to promote cooperation among government, industry, and labor in the area of…

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