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Facility Project Management in the Regulated Pharmaceutical Industry - New Course!

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Facility Project Management in the Regulated Pharmaceutical Industry - New Course!

Dates: 28-29 March 
Location: Frankfurt, Germany 
Instructor: Patricia Melton, PhD, Managing Director, MIME Solutions 

Type: Classroom Training Course 
Level: Intermediate 
CEUs: 1.3


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.

Course Modules

  • Project Initiation
  • Project Delivery Planning
  • Design
  • Procurement
  • Day 1 Exercise & Summary
  • Day 2 Overview
  • Construction
  • Commissioning & Qualification
  • Close out & Review
  • Day 2 Exercises
  • Day 2 Assessment
  • Day 2 Summary

Take Back to Your Job

  • Define a common language within the pharmaceutical Project Management community
  • Define the relationship between project management and the technical aspects of delivering a project: validation, design, procurement, construction, commissioning and qualification
  • Identify the key areas where compliance to cGMP can be positively impacted by the use of "good practice" project management and appropriately manage risk at all stages in the project lifecycle
  • Articulate the key project management concepts, methodologies and tools applicable to each stage in the lifecycle of a typical pharmaceutical facility project
  • Understand the role of risk management and how it should be integrated into each aspect of a project
  • Effectively integrate "hard" project management skills such as cost, change and schedule controls; with “soft” project management skills such as project team building, management of sponsors and customers, etc, in order to ensure that project objectives are achieved and business benefits delivered
  • Apply the principles of “good practice” project management within the regulated pharmaceutical environment appreciating the similarities and the differences between facility projects and other project types
  • Understanding of the Project Management delivery system

Attendance Suggested For

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.

CPIP™ Technical Knowledge and Competency Elements

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.

Continuing Education Units

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.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Project Management (COP).