Project Management for Non-Project Managers - Role of Project Management in Quality Planning throughout the Medical Device Project Lifecycle
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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.
Why Should You Attend:
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 budgets 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
Areas Covered in the Session:
- 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
Who Will Benefit:
- 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
- Research & Development
- Technical Services
- Supply Chain
- Regulatory Compliance
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, training, and technical documentation consulting firm - celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.
He has dedicated his entire professional career explaining the benefits of performance-based training