Effective Project Management in GxP Environment

Description

This training 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. 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.

Objectives

To equip participants with the knowledge and skills to manage projects effectively while ensuring compliance with GxP regulations.

• Understand GxP principles: Train participants on the fundamental principles of Good Practices (GxP) including GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), and GCP (Good Clinical Practice).
• Integrate GxP into project lifecycle: Teach how to incorporate GxP requirements into all stages of the project lifecycle, from initiation to closure.
• Develop compliant project documentation: Instruct participants on creating and maintaining GxP-compliant project documentation, including risk assessments, SOPs (Standard Operating Procedures), and change control procedures.
• Manage risk effectively: Equip participants with tools and strategies to identify, assess, and mitigate risks associated with GxP projects.
• Ensure data integrity: Train participants on maintaining data integrity throughout the project lifecycle, following ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, and Durable).
• Apply Regulatory Considerations: Instruct participants to navigate strict regulations governing GxP product development and manufacturing. 

What You Will Learn

• Define a common language within the pharmaceutical Project Management community
• Identify the relevant GxP regulations applicable to their projects.
• Apply GxP principles to project planning,
• 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, 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 differences between facility projects and other project types
• Implement practices to ensure data integrity throughout the project.
• Effectively communicate GxP requirements to project stakeholders.
• Understanding of the Project Management delivery system

Who Should Attend

• 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
• Managers who are likely to sponsor projects.

Education Approach

• The course sessions are illustrated with examples based on case studies
• Opportunities for participants to ask questions and practice their skills.
• Practical exercises include examples and discussions

Speaker

Kossi Molley, PMP, LSSBB, Chemist, Certified Trainer