Facility Project Management in the Regulated Pharmaceutical Industry

Description

In today’s competitive environment the definition of project success is broader than ever. The successful delivery of facility projects requires the understanding and management of the strategic implications of all current industry trends; the controlled delivery of project objectives to meet business criteria; the management of diverse groups of project stakeholders as well as the motivation of project teams consisting of varied groups of internal and external organisations. Additionally, the pharmaceutical environment requires that compliance to cGMP is integrated into each and every activity so that compliance risks are appropriately and proactively managed.

This course aims to demonstrate the value inherent in the use of “best practice” project management in the regulated pharmaceutical environment within facility projects. 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 and these aspects will be discussed as the course progresses.

The project management benefits of the additional regulatory requirements of the pharmaceutical industry will be demonstrated, i.e., they support a structured proactive approach. The course will also highlight generic “best practices” useful across a number of project types.

This course is specifically aimed at the project management of facility projects within the regulated pharmaceutical industry and so the course is structured around a typical facility project lifecycle:

• Project Initiation: The robust set-up and start of a project – looking at the systems, the stakeholders and the project team members as well as the business needs. Building in compliance from this stage onwards is emphasized.
• Project Delivery Planning: Effective planning at all levels so that risks are mitigated at the earliest opportunity.
• Project Delivery: Design – Management of design from early stage conceptual development through to detailed design.
• Project Delivery: Procurement – Management of all aspects of procurement from contract options for the whole project to working arrangements with specific suppliers.
• Project Delivery: Construction – Management of all aspects of construction from set-up to final handover.
• Project Delivery: Commissioning and Qualification – Management of all aspects of commissioning and qualification from handover to beneficial use.
• Project Close-Out & Review: Effective project completion and project knowledge management.

Each section of the course introduces key generic project management concepts and tools as well as methodologies which specifically support successful project delivery within the pharmaceutical industry. Case study examples are used throughout to illustrate key points.

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

• Articulate the key project management concepts, methodologies and tools applicable to each stage in the lifecycle of a typical pharmaceutical facility project
• Use and adapt the tools and methodologies on their own projects
• Identify the key areas where compliance to cGMP can be positively impacted by the use of “best practice” project management
• 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 “best practice” project management within the regulated pharmaceutical environment appreciating the similarities and the differences between facility projects and other project types
• Appropriately manage risk at all stages in the project lifecycle
• Define the relationship between project management and the technical aspects of delivering a project: validation, design, procurement, construction, commissioning and qualification.

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.

Attendees should have a basic 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.

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.

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.