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SEPTEMBER 2004 INDUSTRY NEWS


Agilent Technologies Selects Microlease and Rosenkranz as Authorized Used-Equipment Resellers in Europe for Agilent Advantage Assurance Program

Agilent Technologies Inc. named Microlease and Rosenkranz as authorized used-equipment resellers in Europe for the Agilent Advantage Assurance program. The program gives European engineers and purchasing agents the option to buy used Agilent test equipment that has been evaluated, fully calibrated and guaranteed by Agilent to meet original performance specifications.

"The Agilent Advantage Assurance program instills confidence in customers who want to purchase used Agilent test equipment at low risk," said Hans Herbert Stromereder, worldwide sales manager of Agilent's Financial Solutions Unit. "The successful extension of the program marks the first time a test-equipment manufacturer has offered to assure the quality of used equipment sold by resellers outside the United States."

Microlease is a leading test equipment solutions company, specializing in rental and pre-owned equipment sales. Since 1979, Microlease has worked with all major electronics organizations, helping them lower the cost of test equipment. With more than 3,000 different product lines, Microlease delivers equipment worldwide and has offices across Europe and the United States.

Rosenkranz-Elektronik GmbH, established in 1951, is one of Europe's biggest suppliers of pre-owned electronic test equipment. The company has a growing inventory of more than 10,000 pieces, which helps satisfy their customers' needs for short delivery times. Rosenkranz-Elektronik GmbH is headquartered in Darmstadt, Germany, with offices and distribution partners across Europe, the United States and Asia.

Under the Agilent Advantage Assurance program, Agilent-brand (formerly HP) used instruments purchased through an Agilent authorized reseller are sent to Agilent for evaluation and calibration to full product specifications. Instruments covered by the program include two years of protection against repair costs and two years of free technical support.

The Agilent Advantage Assurance program will be available in Europe on Nov. 1, 2004. Agilent will continue to name resellers throughout the fourth quarter of 2004.

 

NAPT is Moving

The National Association for Proficiency Testing (NAPT) is relocating. Listed below is our new contact information. Please bare with us as we update our instruction sheets, data sheets, PT Kits, guidance documents, etc. with our new contact information.

For your convenience we have a PDF of our most current list of available ILC/PT's. If we can be of any service to you at this time please do not hesitate to contact us.

As of October 25, 2004 our new location will be:
8100 Wayzata Boulevard
St.Louis Park, MN 55426
As of October 25, 2004 our telephone number will also change to: (763)525-1488. Our fax number will remain the same: (305) 425-5728.

***Reminder*** Time is limited to take advantage of our year end membership offer. Effective January 1, 2005 NAPT Board of Directors will implement an increase to the fee schedule for ILC/PT participation. With a new or renewed multi-year membership agreement you have the opportunity to "lock in" fees at the current fee schedule, for the entire length of the agreement. This is a limited time offer, please do not hesitate to contact NAPT for more information.

 

LeCroy Ships Record Number of Oscilloscopes and Capitalizes on Strong End Market Demand

LeCroy Corporation, a leading supplier of oscilloscopes and serial data test solutions, announced financial results for its first quarter of fiscal 2005 ended September 30, 2004. The first quarter of fiscal 2005 was a 14-week period compared with a 13-week period for the first quarter of fiscal 2004.

Some highlights of the Company's year-over-year financial performance for the first quarter of fiscal 2005 are:
· Orders increased 25 percent to $34.6 million from $27.7 million.
· Revenues grew 29 percent to $35.5 million from $27.4 million.
· Gross margins increased to 58.4 percent from 57.0 percent.
· Operating income increased by 83 percent to $3.7 million from $2.0 million.

"LeCroy continued its momentum going into fiscal 2005 with its strongest first-quarter financial performance in Company history," said President and Chief Executive Officer Tom Reslewic. "Demand was robust for all of our products throughout the quarter from all geographies and business sectors. Our orders grew 25 percent from the same period last year, and we increased gross margins to 58.4 percent, which represented our eighth consecutive quarter of year-over-year gross margin growth. Pro forma operating margins increased to nearly 12% compared to about 7% a year ago demonstrating the strong operating leverage in our business model."

"Sales of our Serial Data Analyzer units increased 25% from a year ago to a record level, reflecting our strategy to focus on the emerging market for serial data test solutions," stated Reslewic. "As part of that strategy, our first quarter was highlighted by our definitive agreement to acquire Computer Access Technology Corporation (CATC) (NASDAQ:CATZ - News)."

"In our end markets, we saw continued strong demand from the Computer market and a surge in sales to Automotive and Industrial accounts, mainly driven by our new serial data solutions for automotive CAN BUS applications," continued Reslewic. "While sales of high-end scopes to the Data Storage market declined year-over-year, we saw significant increases in sales to the Telecom and Educational markets."

"While the Data Storage market in the U.S. was soft, we recorded our ninth consecutive quarter of year-over-year order growth in North America," added Reslewic. "Orders in this region increased 14 percent from the first quarter of fiscal 2004. European orders grew 42 percent over the prior-year quarter, largely driven by the popularity of our WaveRunner and WaveSurfer products. In fact, European orders rose to a record level for a summer quarter, which is typically seasonally slow. We also experienced a 21 percent year-over-year increase in the Asia Pacific region, reflecting strong order patterns in Korea and Japan."

"The WaveSurfer, our low-end product line launched last spring, has surpassed our expectations and enabled us to sell 82% more oscilloscope units in our summer quarter than we sold in the same quarter last year," Reslewic stated. "The WaveRunner line, upgraded to "A" versions earlier this month, continues to lead all of our product lines in terms of revenues and profits. The new WaveRunner 6000A products incorporate significant enhancements in display, processing, performance and productivity."

"We have demonstrated our ability to boost the margins in our business while increasing our sales of low and mid-range oscilloscopes," Reslewic continued. "This dramatic increase in unit sales has a profound impact on LeCroy's brand awareness and reach in the market. With our low- and mid-range products quite fresh and profitable, we are anticipating continued strong growth opportunities as we head into a new product cycle at the high end during the next few quarters. Our future Wide-Band Oscilloscopes and Ultra-Wide-Band Oscilloscopes will set the pace for making the critical signal integrity measurements that are of fundamental importance to today's serial data systems designers."

 

FDA/ISPE Forum on New PAT Guidance

The FDA and ISPE are co-sponsoring a one-day Forum on November 16, 2004 in Arlington, Virginia to help pharmaceutical manufacturing professionals chart a new course for innovation based on Process Analytical Technology (PAT).

The PAT Forum will provide an overview to the tools and principles outlined in the new FDA guidance, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. We'll describe how these concepts can help organizations meet regulatory requirements for validating and controlling the manufacturing process.

PAT is the wave of the future for the pharmaceutical industry. As defined by the FDA, PAT is “a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.” Based on the principle that quality should be built or designed into products, PAT incorporates the most up-to-date concepts of risk management and quality systems into pharmaceutical manufacturing. As a scientific, risk-based framework, PAT is intended to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. The framework is founded on process understanding to facilitate innovation and risk-based regulatory decisions by industry and the Agency.

Learning Objectives
· Obtain an understanding of the PAT framework and its concepts of process understanding and process control
· Obtain an understanding of the PAT tools and principles and how they can be implemented within your organization
· Explore the regulatory processes open to firms who embrace the PAT framework

Agenda
· Guidance Overview
· The PAT Framework
· PAT Regulatory Process: Review and Inspection
· Implementation of PAT: An Industry Perspective
· Challenges and Opportunities of PAT implementation
· An Open Dialogue with the FDA

For more information visit www.ispe.org.

 

Madison Wisconsin NCSLI Section Meeting - Wednesday, November 10th, 2004

This NCSLI section meeting will be held at the Arboretum Centre located on the east side of Waunakee, Wisconsin. A limited number of copies of the new reference source for ASQ's CCT, The Metrology Handbook, published by ASQ Quality Press, will be available for purchase for $75.00 (cash only).

8:30 am - Registration, and get acquainted
9:00 am - Introductions and logistics
9:15 am - I Helped Catch a Killer...The True Story of Calibration in DNA Testing!
- Jay Bucher, ASQ CCT, Bucherview Metrology Services
10:00 am - Break
10:15 am - In House Pipette Management: Frightening or Feasible?
- Keela Sniadach, ASQ CCT, Promega Corporation
11:00 am - Lunch
12:00 pm - Group picture and drawing for door prizes
12:30 pm - Training...Keeping Your Calibration Program 'On Track'
- Corinne Pinchard, ASQ CCT, Promega Corporation
1:00 pm - Board of Directors report; Status of the Twin Cities section customer satisfaction survey; and Status of the Twin Cities Interlaboratory Comparison program
- Terrence M. Conder, NCSLI North Central US Regional Coordinator
1:30 pm - SPL's Metrology program and tour of SPL - Gene Kernan

Please register by calling or emailing our contact person so we can have an accurate head count for information packets/handouts, name tags, etc. There is no cost for attending our meetings. The deadline for registration is 12 (noon) November 5th, 2004. Lunch is "pay as you go", with a cafeteria on-site, and many restaurants in the area.
Attendee Contact: Keela Sniadach, 608-298-4681, Keela.Sniadach@promega.com

Meeting Location: Waunakee Arboretum Centre, 1004 Quinn Dr, Waunakee, WI 53597

 

Edison ESI Metrology Engineering Services News

U.S. Air Force Metrology (AFMETCAL) has selected MudCats SpecTrack to standardize TMDE specifications in electronic format. This invaluable tool enables AFMETCAL to create an extensive database library of TMDE specifications. MudCats SpecTrack systematically categorizes specifications by Function, Range, Parameter, Accuracy, Resolution, and Unit of Measure allowing quick and accurate generation of Specsheets.

MudCats Metrology Suite was designed and developed by Edison ESI Metrology Engineering Services, a subsidiary of Southern California Edison for use in our fifteen laboratories and over 400 seats at commercial customers including the U.S. Air Force, U.S. Army, DOE, pharmaceutical, aerospace and commercial calibration laboratories.

To learn more about MUDCATS, please visit us at www.edisonmudcats.com, or call toll free at 1-866-SCECALS.

 

National Instruments Hosts Technical Conferences in 91 Cities Worldwide

National Instruments has announced open registration for the 2004-2005 NIDays worldwide conference and the NI Technical Symposium, the company’s annual series of virtual instrumentation conferences that reach 42 countries and 91 cities. Beginning in early October and running through April 2005, engineers from around the globe will attend NIDays or NI Technical Symposium for new product presentations, hands-on technical sessions and exhibits on the latest solutions for test, measurement and control applications.

As a part of the international NIDays, an estimated 10,000 engineers, developers, educators and National Instruments Alliance Partner Program members will attend the conferences across Europe, Latin America and Asia-Pacific. Attendees will have the opportunity to exchange ideas on innovative approaches to technical challenges, study future technology trends in virtual instrumentation and learn firsthand how NI software and hardware can save them time and money. NI Technical Symposium brings similar conferences to 29 cities across the United States.

“Virtual instrumentation has achieved mainstream acceptance in test and measurement and is expanding rapidly into new areas such as control and design,” said John Graff, NI vice president of marketing. “The technical presentations at NIDays and NI Technical Symposium will show the latest advances in our modular instrumentation suite of products as well as the new features in NI LabVIEW that are tailored to engineers working with control systems and electronic design.”NIDays and NI Technical Symposium attendees also have the chance to learn about new NI software – such as NI SignalExpress and LabVIEW 7.1 – and new NI hardware – including CompactRIO and M Series, the next generation of multifunction data acquisition devices. These products offer greater flexibility, faster system development and increased system performance. Additionally, attendees will hear from experts on the hottest industry topics during keynote presentations and technical sessions.

NIDays and NI Technical Symposium build on the success of NIWeek, the worldwide virtual instrumentation conference held annually since 1995 near the company’s headquarters in Austin, Texas. NIWeek 2004 concluded in late August with a record attendance of more than 2,000 people who participated in hands-on training, interactive technical sessions, exhibitions and workshops. National Instruments designed NIDays and NI Technical Symposium to bring the excitement and learning opportunities of NIWeek to customers around the world in their native languages and with local NI experts.

For more information and a complete listing of all NI Days and NI Technical Symposium events, visit www.ni.com/events or call 800-444-3539.

 

Transcat Names Charles P. Hadeed, CFO, as Chief Operating Officer

Transcat, Inc., a leading global distributor of professional grade test, measurement, and calibration instruments and a provider of calibration and repair services, is pleased to announce that Charles P. Hadeed has been named Chief Operating Officer, in addition to his positions as Vice President of Finance and Chief Financial Officer. The announcement was made by Carl E. Sassano, Chairman of the Board, President and Chief Executive Officer.

Mr. Sassano stated: "In addition to his superb financial management expertise, Charlie has brought outstanding business management and leadership skills to Transcat which has materially helped us to achieve positive results for fiscal year 2004 that are continuing into 2005. Not only is he a terrific executive with a superb record of accomplishment, he also shares Transcat's vision and strategic direction and our commitment to outstanding service and quality. He will be working closely with me and with the rest of our management team to help our company achieve long-term, sustainable profitability and growth."

Charles P. Hadeed, 54, brings over 30 years of financial and strategic leadership experience to Transcat. Prior to joining the Company, he was Vice President - Heathcare Ventures Group with Henry Schein Inc.; Group Vice President - Operations at Del Laboratories Inc., and in various executive positions, including Vice President-Global Lens Care Operations, President-Oral Care Division, Vice President-Operations-Personal Products Division and Vice President/Controller-Personal Products Division, during his 20-year career at Bausch & Lomb, Inc. Mr. Hadeed earned a B.S. in Accounting from Syracuse University and is a certified public accountant.

Mr. Hadeed commented: "Our strategy in fiscal year 2005 is to focus on gaining business and market share with customers who value quality systems and operate in regulated environments. I am pleased to be working with Carl to help Transcat reach its full potential.

Transcat, Inc. is a leading global distributor of professional grade test, measurement and calibration instruments and an accredited provider of calibration and repair services primarily to the process, life science and manufacturing industries.

FDA Issues Final Report on Its “21st Century” Initiative on the Regulation of Pharmaceutical Manufacturing


Following the second anniversary of the launch of its Pharmaceutical Manufacturing Initiative, the Food and Drug Administration (FDA) issued a final report, dated September 29, that highlights specific steps the agency has taken and will take to develop and implement quality systems management and a risk-based product quality regulatory system.

The report describes the accomplishments and plans for the future resulting from FDA’s completed assessment of the current good manufacturing practice (CGMP) regulations, current practices, and the new tools in manufacturing science that will enable a progression to controls based on quality systems and risk management.

“Americans must have confidence in the quality of their medications even as we face more sophisticated technology and manufacturing processes,” HHS Secretary Thompson said. “This final report provides clear guidance for both FDA and manufacturers to implement a risk-based quality assessment system that will ensure that the drug supply in the United States is of consistently high quality.”

FDA’s initiative has focused on its current regulation of pharmaceutical quality, encompassing veterinary and human drugs, and select human biological drug products such as vaccines. The report addresses FDA’s findings, which put the agency on a path to develop the product quality regulatory system of the future. The report describes specific steps the agency is taking to achieve this system. Some of these include:

· The formation of a Council on Pharmaceutical Quality that will be charged with policy development and continuing change management, including the ongoing implementation of certain quality management systems within FDA relating to pharmaceutical quality regulation;
· A first step in establishing a new risk-based pharmaceutical quality assessment system is to replace the current chemistry, manufacturing and controls (CMC) review system, in the Office of New Drug Chemistry within the Center for Drug Evaluation and Research;
· The issuance of a draft guidance on the role of quality systems in the pharmaceutical current good manufacturing practice regulations to ensure agency regulatory practices encourage similar progress in the pharmaceutical industry as well as enabling manufacturers to tailor their quality system to fit their specific manufacturing environment;
· More systematic risk-based approaches to inspectional oversight of pharmaceutical manufacturing, beginning with pilot implementation of a risk-based model for prioritizing domestic manufacturing sites for many human drug CGMP inspections;
· The issuance of a final guidance on aseptic processing used in the manufacturing of sterile drugs, encouraging the adoption of modern science and technology and risk-based approaches;
· The issuance of a final guidance on Process Analytical Technology (PAT) – a framework for allowing regulatory processes to more readily adopt state-of-the-art technological advances in drug development, production and quality;
· The publishing of a draft guidance on good manufacturing practice for combination products, (i.e., products combining components from two or more of these regulatory categories: drug, device, or biological product);
· Continued active collaboration with the International Conference on Harmonization of the Technical Requirements for Registration of Pharmaceuticals (ICH) and the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), leading to the implementation of an internationally harmonized plan for a pharmaceutical quality system based on an integrated approach to risk management and science; and
· FDA’s decision to seek membership in the Pharmaceutical Inspection Cooperation Scheme – a cooperative agreement among national health regulatory authorities whose purpose includes leading international development, implementation, and maintenance of harmonized CGMP standards and Quality Systems of world-wide pharmaceutical inspectorates.

In addition, the following accomplishments underscore the agency’s commitment to realizing the specific goals of this initiative:

· A proposed rule amending Part 11, Electronic Records, Electronic Signatures – Scope and Application is expected to be published for public comment in 2005;
· A draft guidance on the use of computerized systems in clinical trials, once finalized, will replace the guidance of the same name issued in April 1999;
· The implementation of a technical dispute resolution process for CGMP disputes;
· The upcoming finalization of guidance on preparation and use of a comparability protocol for assessing chemistry, manufacturing and control changes to chemical entities, protein drug products and biological products;
· Improved integration of the preapproval and CGMP inspection programs through training, certification, and Center detail opportunities for the 26 candidates, who have just completed their first level of training, chosen for the Pharmaceutical Inspectorate; and
· The implementation of a revised Charter by the Team Biologics Operations Group that adopts a quality systems management framework, improves processes for communication and coordination between headquarters and the district offices, and further integrates product specialists into the program.

More information on this major initiative, as well as the final report, is available online at www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm.

 

Matheson Tri-Gas' Parent, Nippon Sanso, Successfully Merges with Taiyo Toyo Sanso

Matheson Tri-Gas, Inc.'s parent company, Nippon Sanso Corporation, has successfully completed its merger transaction with Taiyo Toyo Sanso. The new corporation name is Taiyo Nippon Sanso Corporation, and it is now Japan's largest and most influential industrial gas company. Taiyo Nippon Sanso has approximately 240 affiliated and subsidiary companies, with over 7000 employees and a significant presence in 11 countries. Matheson Tri-Gas, Inc. is Taiyo Nippon Sanso's largest subsidiary company.

The new corporation has unveiled a new logo, the definition of which is "transparent and clean," and Matheson Tri-Gas, Inc. will adopt the new logo. This new logo represents the seamless integration of state-of-the-art technology with nature and the new business philosophy which will become the basis of all business activities worldwide.

Regarding the new business philosophy, Mr. Hiroshi Taguchi, President of Taiyo Nippon Sanso states, "Employing a "transparent "management approach, it is our mission to increase our overall effectiveness to better serve our customers and society. We have also incorporated "clean" into our new business philosophy, and I want to emphasize that we will comply with government and regulatory bodies, and will abide by our corporate governance guidelines. We must also endeavor to positively contribute towards environmental issues and to the communities we serve. Furthermore, as a leading industrial company, we must execute on our commitment to safety and quality assurance, as the foundation of our global operations."

William J. Kroll, Chairman, President of Matheson Tri-Gas, Inc. will serve on the Board of Directors of Taiyo Nippon Sanso Corporation, and according to Mr. Kroll, "This is a very important event for Matheson Tri-Gas, Inc. Being part of Taiyo Nippon Sanso Corporation will help us compete much more effectively on the global stage. Matheson Tri-Gas is Taiyo Nippon Sanso's largest subsidiary and we will play a significant role in the success of this new Company, contributing a strong brand name, technology and products. We will have new opportunities to expand our product portfolio, as well as become a significant supplier of products to the new Taiyo Nippon Sanso Corporation."

Matheson Tri-Gas, Inc., is a single source provider of specialty gases, bulk gases, gas handling equipment, and high performance purification systems. The Company also provides support services, engineering services, and systems management services to analytical laboratories and semiconductor manufacturers worldwide. As a Taiyo Nippon Sanso Corporation Company, Matheson Tri-Gas, Inc., is part of a worldwide industrial gas organization focusing on being the single source provider for global customer requirements.


Symposium of Metrology 2004

Since 2001, the Symposium of Metrology, organized by Mexico's National Center of Metrology (CENAM), has turned into an essential meeting place of dialogue and discussion in relation to the progress of Metrology in Mexico. This time the Symposium of Metrology 2004 will also serve as an event to celebrate the 10th anniversary of the official opening of the laboratories existing in CENAM.

As in previous meetings, the participation of metrologists, scientists, professors, students and manufacturers will support the interchange of knowledge as well as experiences in different disciplines of metrology, with the attitude of improving the metrological practices at different levels of application.

The 2004 Symposium will be held at the Hotel Fiesta Americana in Queretaro, Qro. Mexico on October 25 - 27, 2004. Further Symposium details including Sponsors, technical programs, etc. can be found at: www.cenam.mx.

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