TesCom, Oracle and Mercury Interactive Host One-Day Conference:
The 21CFR Part 11 Solutions Conference & Exhibition Enterprise Solutions for Electronic Records and Electronic Signatures - Thursday 30 May 2002
Many pharmaceutical companies, medical device manufacturers and biotechnology companies are unaware of FDA regulations for electronic records and signatures, thereby risking their legal ability to sell into the US market, claims software quality assurance specialist TesCom. The consultancy, together with Oracle and Mercury Interactive, is hosting a one-day conference to address the business and technical issues of putting systems and procedures in place to meet the legislation, fielding experts from such organisations as Abbott Laboratories, gsk, Teva, I-SYS and the BCS CM Specialist Group.
“To sell in the US market, pharmaceutical, medical devices and biotechnology organisations need to comply with '21CFR Part 11' requirements. The long and complex ‘road to compliance’ includes a planning process and an implementation phases-process,” said David Braun, director of industry and pharmaceutical division at TesCom. “This conference has been developed to provide practical information on methods and solutions that help to facilitate these stages, including case studies from organisations that have already achieved compliance.”
The keynote speaker of the conference will be Dr. Nick Dayton, director information & policy, from Abbott Laboratories in Chicago, who specialises in FDA software regulation.
Presentations will be conducted by providers of solutions that should be implemented in this process - PKI, biometric identification, electronic document management, configuration management and more - along with an exhibition of their products and services.
The conference takes place at the Sheraton Skyline Hotel - Heathrow Airport, London. Attendance is free but requires prior registration. For registration contact:
Mr. Barry Clarke
Tel: +44 (020) 7022 6772
Fax: +44 (020) 7022 6701
Mr. Javed Iqbal
Tel: +44 (020) 7022 6773
Fax: +44 (020) 7022 6701
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020 7022 6700
About TesCom Ltd
TesCom mitigates business risk and reduces time to market by delivering independent, tailored software testing and quality improvement services. TesCom is the largest specialist global provider of testing services with a flexible service offering, based on best practice techniques and an in-depth market understanding of its clients’ business sectors. TesCom’s goal is to promote and deliver effective testing to make IT-based business services and applications more user-focused, responsive and robust to meet ever-increasing performance demands. To find out more about TesCom, visit http://www.tescom-intl.com .
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