Azzur IT to participate in IVT’s 16th Annual Computer & Software Validation Conference

Doug Shaw, Director of CSV & IT Consulting, will discuss industry challenges.


Willow Grove, Pa, April 23, 2015 (GLOBE NEWSWIRE) -- Azzur Consulting, a leading provider of consulting services and project resources within the life science industry, today announced Doug Shaw, Director of CSV & IT Consulting, will speak at IVT’s 16th Annual Computer & Software Validation conference on Monday, April 27 at the Hilton at Penn’s Landing, Philadelphia. His talk, “Understand, Address and Overcome CSV Top Challenges in Today’s Global Environment,” will offer a blueprint for assessing the validated status of a computer system inventory. He will also layout an approach on how to remediate existing systems and discuss opportunities to standardize your CSV program moving forward.  

“There is constant change in the life science industry,” said Shaw. “Management changes, frequent technology changes, and mergers and acquisitions can introduce chaos into the even most well-organized validation program. Often, these factors will result in a patchwork of documentation and controls that may present challenges during regulatory inspections. This presentation will address this common industry problem by providing a methodology to evaluate your computer system inventory and explore common CSV deficiencies along with remediation suggestions.”

Shaw will also discuss ways to streamline the validation approach without sacrificing the quality or defend-ability of the final validation package. The talk will include discussion on current CSV topics such as use of SaaS, cloud vendor controls, risk assessment/management, end-to-end Part 11 controls, data integrity controls, efficiency, practicality and scalability.

Shaw has over 20 years of professional experience providing IT compliance solutions to private and governmental organizations regulated by FDA. As the Director of CSV & IT Consulting, he works closely with Azzur Group’s life science clients to identify IT compliance objectives and to develop and implement strategies that balance efficiency with regulatory requirements. He holds a master’s degree in the biological sciences from Hood College and a bachelor’s degree, in biology and chemistry from Radford University. Shaw is a certified information systems auditor (CISA) through the Information Systems Audit and Controls Association (ISACA).

 

About Azzur Consulting

Azzur Group is a Willow Grove, Pa.-based innovative partnership focused on building a Discovery to Delivery™ network across the country in the healthcare and life-sciences industry.

Azzur IT and Azzur Consulting are GxP compliance and consulting organizations dedicated to helping life sciences companies succeed.  The companies offer a network of skilled problem solvers with broad experience across biotechnology, pharmaceuticals and medical device businesses. 

For more information about Azzur Group’s additional life sciences organizations, go to www.azzur.com


            

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