Tunnell Consulting’s Kip Wolf to Present at the Data Integrity & Pharmaceutical Quality Compliance Summit

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Kip Wolf to speak on regulatory guidance for data integrity, with actual case studies to illustrate compliance remediation in the life sciences industry

Poor attention to data integrity can have a negative effect on the altruistic goals of life sciences firms.

Tunnell Consulting, an organization dedicated to solving complex problems for life sciences companies and government agencies, announced that one of its principals, Kip Wolf will be a featured speaker at the Data Integrity & Pharmaceutical Quality Compliance Summit, to be held March 4 and 5 in Boston. Wolf’s presentation on “Regulatory guidance for data integrity” will take place on March 4 at 8:30 a.m. immediately following the Chairperson’s Welcome and Opening Remarks.

Beginning with an overview of regulatory and guidance documents that relate to data integrity in the life sciences industry, Wolf’s presentation will describe how data integrity fits into the regulatory framework of the life sciences industry, cover the current regulatory compliance landscape and inspection results, and will include specific case studies highlighting compliance issues and related remediation.

“Poor attention to data integrity can have a negative effect on the altruistic goals of life sciences firms,” said Wolf. “The primary goal of improving health and curing disease can be compromised when data integrity is not attended to from the very beginning of the process, and when quality practices remain immature or are not adhered to. And when those altruistic goals are compromised by a lack of data integrity, the economic goals of the organization will be compromised as well.”

Wolf’s presentation will include specific examples and case studies showing compliance problems such as poor user account management or falsification of data, and how they have been remediated with a more comprehensive approach to data integrity and an enabling quality culture.

With more than 25 years of experience, Kip Wolf has held leadership positions at some of the world’s top life sciences companies. At Tunnell, as Principal he brings his product development program management experience to bear to improve the probability of successful regulatory filing and product launch. He also leads the data integrity practice at Tunnell and consults, teaches, speaks and publishes regularly on topics of data integrity and quality systems.

The Summit will be held at the Metro Meeting Center in Boston, March 4 and 5, with comprehensive coverage on some of the most important data integrity issues facing the life sciences industry today.

About Tunnell Consulting
Founded in 1962 and serving many of the world's leading life sciences firms and government agencies, Tunnell Consulting, Inc. integrates strategic, technical, process, quality, regulatory and organizational skills to design and implement sustainable solutions that exactly meet client needs. With deep industry knowledge, extensive scientific credentials, and superior measurable results, we consistently boost the operating performance of each unique client we serve. To learn more, visit us online at http://www.tunnellconsulting.com.

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