Challenges and Solutions for FDA Regulated Companies Free Seminar Scheduled for September 24, in Chicago

Presenting a Free Seminar detailing FDA Regulations for medical device manufacturers and their suppliers. This valuable seminar prepares medical device manufacturers and suppliers for FDA compliance and validation by explaining the FDA expectations including; 21 CFR Part 11, Digital Signatures, Secure Document Control, Configurable Software System Validation, and Validation Ready" Software.

Royal Oak, Mich., July 22, 2002 -- Integral Solutions, Inc. (ISI), a full-service quality control and engineering data management software, training, and consulting firm, in partnership with DiMetrix, Document Control Systems and GE Fanuc will present a Free Seminar detailing FDA Regulations for medical device manufacturers and their suppliers.

This valuable seminar prepares medical device manufacturers and suppliers for FDA compliance and validation by explaining the FDA expectations including; 21 CFR Part 11, Digital Signatures, Secure Document Control, Configurable Software System Validation, and Validation Ready" Software.

Challenges and Solutions for FDA Regulated Organizations will feature keynote speaker Carl J. Accettura - veteran of FDA regulated operations, with 18 years of diversified global experience in pharmaceuticals and medical devices. Carl has had direct responsibility for regulatory compliance, validation, and FDA inspection-readiness. He has created corporate policies and procedures for compliance with cGMP, and 21 CFR Part 11. Carl has expertise in pharmaceutical and medical device production operations, including new product planning, time-to-market initiatives, manufacturing, quality systems, quality control, project management, strategic planning, and supply chain.

Scheduled presentations include:
Carl Accettura presents -- 21 CFR Part 11 -- Computer Systems Validation Challenges and Solutions"
Chris Ackerman, Integral Solutions Inc. Methodologies and Tools for Efficient and Effective Quality Planning"
Jack Wilkins, GE Fanuc -- CimWorks, Effective Statistical Process Control in a 21 CFR part 11 Environment"
Darren Dibb, Document Control Systems, Exceeding FDA Regulations for Document Control"

The seminar is scheduled for Tuesday September 24, at the Holiday Inn in Rolling Meadows, Ill. (just outside of Chicago). Attendance is free , and space can be reserved through DiMetrix, by calling (847) 781-9596, or e-mail name, title, company, address, phone and fax to info@dimetrix.com.

Visit ISI on the web at: www.integralsolutions.com.
Visit DiMetrix on the web at: www.dimetrix.com
Visit Document Control Systems on the web at: www.mastercontrol.com
Visit GE Fanuc on the web at: www.gefanuc.com