Dates: 28-29 March
Location: Frankfurt, Germany
Instructor: Patricia Melton, PhD, Managing Director, MIME Solutions
Type: Classroom Training Course
The practice of Project Management within the highly regulated world of the pharmaceutical industry provides unique challenges and opportunities. Do you have the tools to support successful project delivery in this environment?
This course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits, providing tools to manage all project resources. It is specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment.
Trends in regulatory compliance, environmental, health and safety legislation, project delivery methodologies and product speed to market expectations all impact how pharmaceutical facility projects are managed. Each course module introduces key generic project management concepts and tools as well as methodologies which specifically support successful project delivery within the regulated pharmaceutical industry. This course is structured around a typical facility project lifecycle of Project Initiation, Delivery Planning, Design Planning and Delivery, Procurement, Construction, Commissioning and Qualification and Project Close-Out & Review and uses case study examples throughout to illustrate key points.
Immediately apply the course learning objectives with the complimentary copy of the ISPE Good Practice Guide: Project Management.
Note: Attendees should have a basic sound understanding of GMP and the pharmaceutical industry as well as the basic concepts of project delivery i.e. cost, schedule and scope planning and control.
Personnel entering facility project management coming from another discipline within the pharmaceutical industry; those with 2-3 years experience within a project role looking to improve their project delivery capability; engineers, project engineers, quality and IT professionals likely to support or deliver projects within their role, and managers who are likely to sponsor projects.
This course contains knowledge related to the CPIP™ technical knowledge competency elements Facilities and Equipment: Design and Construction / Installation and Production Systems: Production Control. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.