Good Practice Guide: Project Management for Pharmaceutical Industry

Title:

Author(s):

Angelastro, Jamie; Barlow, David; Butler, Jeffrey H.; Davies, Nick C.; Errico, Stephen; Gibbs, Keith; Gunderlock, Rich; Honey, John; Hura, Leo; Iles-Smith, Peter; Kelly, Sean; Koncak, Dave; Lamson, Keith; Loxley, Paul; Lynam, Mick; McCann, Chris; McGlade, James W.; Melton, Trish, PhD; O'Donnell, Kevin; Odum, Jeffrey N., CPIP; Penfold, Alf; Phelan, Joe; Roberts, Andrew; Scherzer, Raymond H.; Shelden, Wade; Spanel, Greg; Stefanowicz, Matt; Theobald, Matthew; Thorne, Ian

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Author(s): Angelastro, Jamie; Barlow, David; Butler, Jeffrey H.; Davies, Nick C.; Errico, Stephen; Gibbs, Keith; Gunderlock, Rich; Honey, John; Hura, Leo; Iles-Smith, Peter; Kelly, Sean; Koncak, Dave; Lamson, Keith; Loxley, Paul; Lynam, Mick; McCann, Chris; McGlade, James W.; Melton, Trish, PhD; O'Donnell, Kevin; Odum, Jeffrey N., CPIP; Penfold, Alf; Phelan, Joe; Roberts, Andrew; Scherzer, Raymond H.; Shelden, Wade; Spanel, Greg; Stefanowicz, Matt; Theobald, Matthew; Thorne, Ian

The ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry provides good practice approaches which promote the successful integration of GxP with relevant project management activities to ensure that compliance risk is managed effectively and proactively.

The Guide discusses: 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 is integrated with the project life cycle.