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MAY 2006 NEWS

 

Metrology Seminar will Debate Upgrades

The third Middle East Metrology Conference and Exhibition will be held at the Bahrain International Exhibition Centre from May 29 to 31.

The Middle East Measurement and Instrumentation 2006 is being organized by the Industry and Commerce Ministry in association with the Bahrain Defense Force, Bahrain Society of Engineers and Bahrain International Exhibition Centre.

The conference aims to address the need to update information on measurement and instrumentation, providing a platform on which international standards for industrial-process measurement and instrumentation control may be discussed and also their standardization.

A total of 45 papers have been accepted by the technical committee for presentation at the conference that will include a mix of metrology and instrumentation to be presented by experts from leading universities and companies.

Companies like Saudi Aramco, Emerson Process Management, Gulf Petrochemical Industries Co, Bahrain National Gas, Aluminium Bahrain and Yokogawa have confirmed their support for the event.

The conference will also host an exhibition where companies dealing with process technology and calibration services will be exhibiting their products and services.

A pre-conference workshop on Uncertainty Calculation in Measurement and Calibration will be held on May 27 and 28.

It is ideally suited for heads of measurement, inspectors of laboratories, university staff and students who are concerned with the issue.

Registration is in progress and delegates interested in attending the conference may call the Bahrain Society of Engineers on 17727100, fax 17729819 or e-mail bseng@batelco.com.bh or visit www.middleeastmetrology2006.com.

 

Lloyd Instruments’ Service Partner Accredited to ISO 17025

Lloyd Instruments is delighted to announce that its service partner in India, Hemshell Services PVT.Ltd, has received accreditation to ISO17205 for site force calibration of Universal Materials Testing Machines. The scope of this accreditation is up to 10T capacity. Calibration certificates are supplied with all the necessary data together with evidence of traceability back to the calibration masters.

This is the culmination of 3 years work, and the assessment was carried out by India's National Accreditation Board for Testing and Calibration Laboratories (NABL). Engineers from Lloyd Instruments worked closely with Hemshell Services for the transfer of the appropriate test and calibration procedures needed. A team of 8 engineers from Hemshell Services is now authorized to carry out calibration.

A comprehensive range of calibration and certification services is offered for universal testing machines. These include load cell calibration and certification, extensometer calibration and certification and speed calibration and certification.

Calibration and certification services are also important for other plastics and polymer evaluation systems and Hemshell also offers temperature calibration and precision die, barrel calibration and certification services for Melt Flow Indexers. For HDT / VICAT test systems, the company provides temperature calibration as well as dial gauge calibration and certification. Temperature calibration and certification and LVDT calibration and certification are also offered for Melt Viscometers (for testing PET).

Lloyd Instruments is a unit of AMETEK Test & Calibration Instruments. Both are part of AMETEK, Inc., a New York Stock Exchange-listed company and a leading global manufacturer of electronic instruments and electric motors with annual sales of $1.3 billion. Visit http://www.lloyd-instruments.co.uk for more information.

 

GE Analytical Instruments Offers Cleaning Validation Training

GE Analytical Instruments offers cleaning validation seminars at selected locations throughout the world, and can also provide on-site instruction. The seminars include TOC for Cleaning Validation and TOC for PAT Applications.

TOC for Cleaning Validation: Total Organic Carbon Analysis Seminars
Cleaning Validation requires solid preparation and careful planning of multiple steps in the cleaning process of pharmaceutical manufacturing equipment. GE Analytical Instruments' TOC for Cleaning Validation Seminar offers a systematic but rational approach to cleaning validation and the vital components associated with a cleaning validation program. The program offers attendees challenging cleaning validation case studies, best practices documentation, and TOC strategies from a pharmaceutical laboratory and operations point of view. The seminar covers:

  • Background information on regulations, expectations and cGMP’s for the 21st Century
  • Understanding and evaluating your processes requirements and capabilities
  • Procedures, protocols and reports
  • Analysis of TOC
  • Implementing TOC into your facility
  • Ongoing cleaning validation monitoring
  • Hands on-time with the instrumentation

Our 2006 TOC for Cleaning Validation Seminar schedule includes:

  • London, UK July 18
  • Runcorn, UK July 19
  • Newcastle, UK July 20
  • Dublin, Ireland July 24
  • Cork, Ireland July 26

For more information about this seminar and the other seminar TOC for PAT Applications visit: http://www.geinstruments.com/ionics/index.cfm?attribute_code
=CV%20%2D%20Training&product_code=Pharm%20%2D%20CleanVal
&category_code=Pharmaceutical

 

EUROMET’s April 2006 News
EUROMET is a cooperative voluntary organization between national metrology institutes (NMIs) in the EU and EFTA, including the European Commission. Established NMIs from other European states can also be members subject to the agreement of existing members. Currently, EUROMET has 34 members, with nearly every European state represented.

The objective of EUROMET is to promote the coordination of metrological activities and services with the purpose of achieving higher efficiency.

Visit Euromet’s website at www.euromet.org and access their April 2006 newsletter. The newsletter contains information on the upcoming 20th EUROMET General Assembly, news from members, information on the 2007 International Metrology Congress being held in France, and links to updates on the status of EUROMET projects.

The Newsletter can be directly accessed in pdf format at http://www.euromet.org/docs/chairman/docs/EM-nl-0604-p.pdf.

 

Total Support for European Chemical Substance Regulations
 Comprehensive inspection methods for complying with RoHS, WEEE and ELV Directives

Since its founding in 1875, Shimadzu has promoted and maintained a balance between providing technological solutions and promoting activities to conserve the environment. This concern for the environment has led to the development of such items as environmental monitoring systems and biodegradable plastics. Since establishing the "Global Environmental Code of Conduct" in 1994, Shimadzu has been striving to maintain an environmental management system, placing greater importance on recycling while introducing an LCA (Life Cycle Assessment) Method to aim for the development and manufacture of "Environmentally Friendly Products."

This environmental concern makes Shimadzu your ideal partner for complying with the following European directives:

  • RoHS - Restriction of Hazardous Substances in Electrical and Electronic Equipment
  • WEEE - Waste Electrical and Electronic Equipment
  • ELV - End-of-Life Vehicle

In order to support compliance with these regulations, Shimadzu is now establishing a worldwide analytical consulting and maintenance capability. From application development to inspection methods, Shimadzu offers a variety of instruments to help customers prepare systems for complying with RoHS, WEEE, and ELV requirements.

 

2006 PDA/EMEA Joint Conference - Understanding the European GMP Environment
10-13 October 2006
London, England

Mark your calendar for this opportunity to meet European regulators and learn about the latest developments in GMPs and inspection activities in the European Union. Continuing its tradition of service and leadership, PDA is proud to celebrate its 60th anniversary by partnering for the first time with the European Medicines Agency (EMEA) to offer the 2006 PDA/EMEA Joint Conference. This is a unique opportunity to interact directly and network with top European health authorities and industry representatives in a neutral, science-based forum.

Who Should Attend

  • Those working in development, production, compliance, quality and regulatory functions
  • Regulators and health authority leaders
  • Those affected by, or interested in the conduct, process and outcomes of inspections in the European environment
  • Representatives of the pharmaceutical and biopharmaceutical industries

For more information, visit www.pda.org/pdaemea2006.

 

13th International Metrology Congress
Lille, FRANCE
June 18-21, 2007
http://www.cfmetrologie.com/congres_en.php

The International Metrology Congress is organized every two years by the French College for Metrology. The aim of the Congress is:

  • To bring forth and to highlight new techniques of measurement and calibration that have been or are being developed.
  • To present the evolution of metrology, and its implication in industry, research, environment and safety economy and quality, at the national and international level.

The Congress gathers more than 800 people, from 45 different countries, and from every circle concerned with measurement:

  • Metrologists from companies
  • Metrologists from calibration, analysis and testing laboratories,
  • Manufacturers and users of metrological equipments,
  • Quality managers,
  • Teachers and researchers.

Download the Call for Paper 2007 at: http://www.cfmetrologie.com/include/docs/call4papers.pdf.

 

Success of EU Pharmaceutical Industry to Depend on Proactive Regulatory Legislation

Across Europe, the emergence of new diseases and expanding drug pipelines is being accompanied by progressively stricter ethical and regulatory frameworks. In addition to protecting public health, drug discovery legislation is attempting to address the entry of new European Union (EU) member states through the implementation of a single, harmonised EU-wide pharmaceutical market. Against this backdrop, the role of proactive legislation in facilitating efficient, cost-effective and rapid drug discovery will support the continued success of the pharmaceutical industry in the EU.

Currently, the pharmaceutical industry is grappling with intensifying cost pressures, shorter product life cycles and varied clinical trial data management issues. Moreover, high failure rates have been additional cause for anxiety.

A host of regulatory challenges that threaten to stifle commercial operation has exacerbated this situation. For instance, notwithstanding the efforts of pharmaceutical and biotechnology companies, the stringent requirements governing drug labelling in clinical trials has proven to be a major hindrance in obtaining rapid regulatory approval.

At the same time, however, the lack of adequate follow up procedures has meant that companies often confront unacceptable delays in getting approval besides losing considerable time and money. This situation is more serious in countries where strict legislations and regulatory procedures are absent.

"Fundamental drivers that will improve and strengthen the evolution of the drug discovery process in western and eastern Europe are yet more strict regulations, mandatory good manufacturing practice (GMP) compliance and improved legislations for clinical trials to create opportunities for an efficient competitive environment," says Frost & Sullivan (http://www.healthcare.frost.com) Research Analyst Dr. Amarpreet Dhiman.

To retain Europe's pre-eminent position in the global pharmaceuticals market, regulatory policies have continually aimed at maintaining, updating and simplifying pharmaceutical legislation while also drafting new guidelines.

Over the last seven years, the pharmaceutical industry has gained increasing familiarity with the centralised and mutual recognition regulatory procedures. With the expiry of the so-called transition period in 1998, these two procedures have become the dominant pharma registration models within the EU.

Since the mid 1980s, several directives have aimed at realising a single, EU-wide market for pharmaceuticals. For instance, the EU directive 2001/20/EC on clinical trials - the Good Clinical Practice (GCP) directive - was made fully effective by member states in May 2004. It ushered in important changes harmonising the key legal requirements and procedures for conducting clinical trials on medicinal products for human use in the EU.

"Efforts at creating a single market have been geared not only to enhancing quality of life indicators, but equally to strengthening the long-term competitiveness and research capabilities of the European pharmaceutical industry," says Dr. Dhiman.

Future projections are upbeat and include fast-track approval for innovative medicines, harmonised data protection and follow up of the Lisbon Agenda and G10 process. By 2012, the EU can look forward to enhanced centralised procedures, the introduction of specific measures for small and medium-sized enterprises as well as increasing prominence of personalised medicine.

Regulatory Hurdles in European Drug Discovery is part of the Drug Discovery Technologies Subscription, which also includes research in the following markets: European Drug Discovery Market, Biochips in Drug Discovery in Europe, Drug Discovery--European Advances in Genomics and Proteomics, Opportunities for Bioinformatics in European Drug Discovery Market. All research included in subscriptions provide detailed market opportunities and industry trends. All research is evaluated following extensive interviews with market participants. Interviews are available to the press.

If you are interested in a virtual brochure, which provides manufacturers, end users, and other industry participants with an overview of the latest analysis of the Regulatory Hurdles in European Drug Discovery (B730- 55) then send an e-mail to Radhika Menon Theodore - Corporate Communications at rmtheodore@frost.com with the following information: your full name, company name, title, telephone number, e-mail address, city, state, and country. The information will be sent to you via email upon receipt of the above information.

 


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