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ISPE

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ISPE Supports Pharmaceutical Industry with Guide for Project Management

Specific tools and techniques to integrate regulatory compliance with the project life cycle

Published: Thursday, January 19, 2012 - 17:02

(ISPE: Tampa, FL) – The International Society for Pharmaceutical Engineering (ISPE) has released a new industry guidance document, Project Management for the Pharmaceutical Industry. This guide is the first document of its type to discuss and compile best practices for project management concepts within the context of the pharmaceutical industry. The guide serves as a toolkit to help pharmaceutical project managers deliver successful projects quickly. It also offers content that addresses managing risks common to pharmaceutical projects and develops a common language for the pharmaceutical project management community.

“The pharmaceutical industry presents unique regulatory and business aspects to the field of project management,” says Trish Melton, one of the guide’s lead authors. “Increased speed to market for new drugs has meant that most projects are under pressure to deliver faster while maintaining compliance in a shifting regulatory environment, and meeting cost and scope objectives in an increasingly competitive market. This welcomed guide is the industry’s first to offer user-friendly, specific tools and techniques to integrate regulatory compliance with the project life cycle.”

Project Management for the Pharmaceutical Industry is a reference source of good practices for project management. The guide covers a variety of project types within the pharmaceutical industry, including facility, improvement, product, IT, and automation projects.

The guide covers the tools and techniques supporting project delivery, the life cycle of a typical project in the pharmaceutical industry, and how compliance to pharmaceutical industry regulations should be integrated with the project life cycle. Key concepts include business context, regulatory context, value management, technology and innovation, collaborative working, integrated validation life cycle, integrated risk management, and the stage gate approach.

To complement the guide, ISPE will debut its facility project management training course on March 19-20, 2012, at ISPE’s training event in San Diego and at the ISPE Aseptic EU conference in Frankfurt, Germany, March 28–29, 2012. The course will focus on the project management of facility projects. 

For more information on the ISPE “Project Management for the Pharmaceutical Industry,” or to order an electronic copy or bound version, click here.

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ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.