This Guide is the industry’s first to offer user-friendly, specific tools and techniques to integrate regulatory compliance with the project lifecycle.
Tampa, Florida USA (PRWEB) January 16, 2012
ISPE announced today that it has released a new industry Guidance Document, Project Management for the Pharmaceutical Industry. This ISPE Good Practice 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,” said Dr. 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 lifecycle.”
The ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry is a reference source of good practices for project management. The Guide covers a wide 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 lifecycle of a typical project in the pharmaceutical industry, and how compliance to pharmaceutical industry regulations should be integrated with the project lifecycle. Key concepts include Business Context, Regulatory Context, Value Management, Technology and Innovation, Collaborative Working, Integrated Validation Lifecycle, Integrated Risk Management, and the Stage Gate Approach.
To complement the Guide, ISPE will debut its Facility Project Management Training Course on 19 – 20 March 2012 at its San Diego, California USA training event and 28 – 29 March at the ISPE Frankfurt Conference. The course will focus on the project management of facility projects. For more information on the course, visit http://www.ISPE.org/training.
For more information on the ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry, or to order an electronic copy or bound version, visit http://www.ISPE.org/ISPE-Good-Practice-Guides/Project-Management-Pharmaceutical-Industry.
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” by providing Members with opportunities to develop their 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 opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit http://www.ISPE.org for additional Society news and information.