Facility Project Management in the Regulated Pharmaceutical Industry (T26)

Level: Intermediate - Application
Course Number: T26-5226
ISPE CEUs: 1.3
PMI PDUs: 13
Type: Classroom Training Course

ISPE has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI^®)

Description

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.

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

• Guide Introduction
• Human Resource Management
• Risk Management
• Project Initiation
• Project Delivery Planning
• Pharmaceutical Specific Design Planning and Delivery
• Implementation: Procurement
• Implementation: Construction
• Implementation: Testing and Commissioning
• Project Close-out

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.

Community of Practice (COP)

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

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

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.

Provider is a member of PMI’s R.E.P. Program and PMI does not specifically endorse, approve, or warrant R.E.P’s products, courses, publications, or services.