Project Management for Non-Project Managers Series - Role of Project Management in Quality Planning Throughout the Medical Device Project Lifecycle

Project management plays a critical role in ensuring quality planning and management throughout the product lifecycle. It involves the application of knowledge, skills, tools, and techniques to effectively manage and coordinate resources, timelines, and budget to deliver a high-quality product that meets customer requirements.

In the context of quality planning, project management involves the following functions:

• Defining Quality Objectives: Project managers work with stakeholders to define quality objectives for the product or service. This includes identifying key performance indicators (KPIs), measurable quality criteria, and the specific requirements that the product must meet.
• Creating a Quality Management Plan: The project manager develops a comprehensive quality management plan that outlines the steps required to achieve the quality objectives.
• Identifying and Managing Risks: The project manager identifies potential risks to quality and develops a risk management plan to mitigate these risks. 
• Implementing Quality Control Procedures: The project manager oversees the implementation of quality control procedures throughout the product lifecycle. This includes conducting quality audits, testing the product at various stages, and implementing corrective actions to address any issues that arise.
• Ensuring Continuous Improvement: Project managers monitor and evaluate the product throughout its lifecycle to identify areas for improvement. 

This webinar will bridge the link between quality planning and project management process as they relate to the pharmaceutical and biomedical industries.

Why You Should Attend:

Project management plays a critical role in ensuring quality planning and management throughout the product lifecycle. The project manager is responsible for creating a comprehensive quality management plan, implementing quality control procedures, and identifying areas for continuous improvement. By doing so, they ensure that the final product meets the quality objectives and customer requirements. These are the important elements that need to be considered by the project manager when initiating and executing the project.

Learning Objectives:

• Describe the relationship between quality planning and project management.
• Identify the quality functions that must be executed during product development.
• Review the medical device development process as it relates to quality planning and execution.
• Discuss how ensuring manufacturing quality fits into the medical device development process.
• Explain the role quality audits play in maintaining quality across the entire medical device development process.

Areas Covered in the Session :

• Overview of the relationship between quality planning and project management
• Quality functions during product development
• Project planning
• Design inputs
• Design outputs
• Design verification and validation
• Acceptance and design transfer
• Manufacturing quality
• Device history records
• Supplier identification and rating
• Post-market surveillance
• Managing the results of post-market surveillance
• Design changes
• Quality audits

Who Should Attend:

Any member of a cross functional project team:

• Engineers
• Marketing Associates
• Design Engineers
• Product Managers
• Program Managers
• Contract Managers
• Project Managers
• Research & Development Associates, Managers, and Directors
• Manufacturing Managers
• Technicians
• Supply Chain Professionals
• Operations
• Anyone that participates in or has the potential to manage team-based cross-functional projects.

This course crosses all industries and functions it is however particularly suited for the health sciences and other regulated industries where much project-based work is accomplished. The types of industries that are targeted include:

• Medical device manufacturers
• Pharmaceutical and Biotech organizations
• Cosmetic and foods manufacturers
• All other industries

Topic Background:

This webinar is intended for those that have a basic understanding of generic project management approaches; both traditional and agile.  The focus of this training is to gain an understanding of how quality is ingrained into the medical device development project.  

Project managers develop the schedule and allocate the resources to ensure that a completed project meets the needs of the company and the intended use for the customer.  

Allocating quality resources in the beginning of the project allows quality planning to be embedded into the schedule avoiding delays due to lengthy review and rewrite cycles for existing projects. Understanding quality processes and input requirements decreases the schedule impact of quality reviews.  

Quality driven projects involving changes updates or post project surveillance rely on effective data acquisition and analysis for the project outcome.  

The project managers need to understand these quality requirements.  PMs must drive the completion of milestone deliverables while keeping a focus on quality.  This webinar will address those quality needs, techniques and requirements.

Course Director: CHARLES H. PAUL

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.