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Pilgrim Software Presents Free Educational Workshops for FDA-Regulated Manufacturers


Tampa, FL – April 18, 2006 –
Pilgrim Software, Inc., the leading provider of Enterprise Compliance and Quality Management Solutions, has joined with leading Life Science manufacturers and former FDA officials to present “Knock Out Non-Compliance,” a series of free educational workshops for FDA regulated companies and their suppliers and partners.  Industry insiders will offer expert advice on effective preparation for quality and compliance inspections, and ways to improve quality, safety and efficiency across a business’ entire chain of care.

The featured speakers will discuss new FDA regulations, auditing processes, and expectations for cGMP requirements, including today’s foremost compliance issues. Operational excellence, continuous improvement, compliance activities, and FDA current hot topics such as a risk-based approach will also be presented.

Panelists will include Sandra Whetstone, former FDA director of the Division of Compliance Management and Operations, and co-founder and managing member at CCS Consulting; Betty Jones, former FDA acting director of the Office of Compliance, and co-founder and managing member at CCS Consulting; and, Garry Bandel, regulatory affairs specialist and retired Abbott Laboratories executive.

Additionally, executives from leading Life Sciences companies, including Cardinal Health, Genzyme, and Stryker Biotech, will present case studies revealing how their organizations have developed effective compliance and quality processes leading to operational excellence. 

“Too often manufacturers believe regulatory compliance means discovering what the FDA wants it to do, after they’ve already deviated from requirements,” said Ami Utji, chief executive officer of Pilgrim Software, Inc.  “No company wants to become a 483 statistic. These educational workshops will advise attendees how to avoid FDA penalties by ensuring their businesses are fully compliant at all times.”

The half-day regional workshops are being held in the following cities: 

May 9, 2006 – Tampa, Florida 
May 17, 2006 – Research Triangle Park, North Carolina 
May 23, 2006 – Boston, Massachusetts
May 25, 2006 – Raritan Center, New Jersey
June 6, 2006 – Chicago, Illinois
June 8, 2006 – Minneapolis, Minnesota
June 20, 2006 – Foster City, California
June 22, 2006 – Los Angeles, California

The workshop also will include a Product Showcase hosted by Pilgrim Software.  Pilgrim will present a demonstration of its SmartSolve modules and discuss how this off-the-shelf automated solution is helping Life Sciences manufacturers avoid the risk of non-compliance.


About Pilgrim Software, Inc. 
Pilgrim Software, Inc. is the leading provider of Enterprise Compliance and Quality Management solutions for global organizations. Pilgrim helps organizations manage industry and regulatory compliance, reduce manufacturing costs and improve customer satisfaction. For more information, visit Pilgrim Software’s Web site at www.pilgrimsoftware.com.

For more information about the free educational workshops, click here.