Quality Planning in Medical Device Projects: A Comprehensive Training for Non-Project Managers

Transforming Medical Device Projects – The Power of Quality-Driven Project Management!

Instructor :
Charles H. Paul

Webinar ID:
8818

Date: DEC 06, 2024 (FRI)

Start Time: 10 AM PT - 11:30 AM PT

Duration: 90 Mins.

What you will learn

  • Quality Planning & Project Management Relationship
  • Product Development’s Quality Functions
  • Medical Device Development Process & Quality Planning
  • Project Planning, Design Inputs, Outputs, Design Verification and…
  • Quality Planning & Project Management Relationship
  • Product Development’s Quality Functions
  • Medical Device Development Process & Quality Planning
  • Project Planning, Design Inputs, Outputs, Design Verification and Validation
  • Manufacturing Quality in Medical Device Development
  • Role of Quality Audits in the Medical Device Development Process and More..

Course Description

  • Do you find managing complex, multi-stakeholder projects daunting?
  • Is juggling project management with quality assurance tasks challenging for you?
  • Do you need guidance to handle your overwhelming workload effectively?
  • Are you seeking tools for better collaboration and communication within cross-functional teams?
  • Are you looking for efficient ways to measure project success and identify improvements?
  • Does staying updated with changing FDA and international standards while ensuring project compliance worry you?

” If you’ve answered ‘yes‘ to any of the questions above, then our training is tailor-made for you – This is your chance to master the art of quality planning in medical device projects, even if you’re not a project manager! “

As the medical device industry becomes increasingly complex and competitive, effective project management plays a pivotal role in ensuring successful quality planning throughout the project lifecycle.

Navigating a project can feel like braving the high seas without a compass. This is especially true for professionals who do not typically manage projects but find themselves responsible for their success.

This interactive webinar is designed as your navigational guide. With a focus on the unique aspects of the medical device industry, this course offers a clear road map to

  1. Successful project management
  2. Quality planning
  3. The delivery of high-standard medical devices.

In this transformative course, you will delve into the core principles of project management, honing your skills to drive seamless quality planning, efficient resource allocation, and successful project execution.

Our expert instructor will guide you through real-world case studies and practical insights, equipping you with the tools to thrive in medical device project management, irrespective of your prior experience.

Don’t let the chance to revolutionize your role and contribute to project success pass you by. Register today and step into a world where project management is no longer a labyrinth, but a powerful tool at your disposal.

Join Now!

  • Do you find managing complex, multi-stakeholder projects daunting?
  • Is juggling project management with quality assurance tasks challenging for you?
  • Do you need guidance to handle your overwhelming workload effectively?
  • Are you seeking tools for better collaboration and communication within cross-functional teams?
  • Are you looking for efficient ways to measure project success and identify improvements?
  • Does staying updated with changing FDA and international standards while ensuring project compliance worry you?

” If you’ve answered ‘yes‘ to any of the questions above, then our training is tailor-made for you – This is your chance to master the art of quality planning in medical device projects, even if you’re not a project manager! “

As the medical device industry becomes increasingly complex and competitive, effective project management plays a pivotal role in ensuring successful quality planning throughout the project lifecycle.

Navigating a project can feel like braving the high seas without a compass. This is especially true for professionals who do not typically manage projects but find themselves responsible for their success.

This interactive webinar is designed as your navigational guide. With a focus on the unique aspects of the medical device industry, this course offers a clear road map to

  1. Successful project management
  2. Quality planning
  3. The delivery of high-standard medical devices.

In this transformative course, you will delve into the core principles of project management, honing your skills to drive seamless quality planning, efficient resource allocation, and successful project execution.

Our expert instructor will guide you through real-world case studies and practical insights, equipping you with the tools to thrive in medical device project management, irrespective of your prior experience.

Don’t let the chance to revolutionize your role and contribute to project success pass you by. Register today and step into a world where project management is no longer a labyrinth, but a powerful tool at your disposal.

Join Now!

Why you should attend

The medical device industry is fraught with unique challenges, from stringent regulatory demands to high-stakes quality requirements. Non-compliance can lead to costly errors and project delays!

Research shows that 70% of projects fail due to a lack of planning and control, costing businesses billions every year.

This course aims to equip non-project managers with the skills and knowledge to prevent such outcomes, ensuring a successful medical device project lifecycle from start to finish!

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 course will not only clarify the key elements of project management but will also demonstrate how these elements directly affect the quality of medical device projects. Attend to gain a valuable edge in driving your projects to successful completion.

Enroll Now!

The medical device industry is fraught with unique challenges, from stringent regulatory demands to high-stakes quality requirements. Non-compliance can lead to costly errors and project delays!

Research shows that 70% of projects fail due to a lack of planning and control, costing businesses billions every year.

This course aims to equip non-project managers with the skills and knowledge to prevent such outcomes, ensuring a successful medical device project lifecycle from start to finish!

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 course will not only clarify the key elements of project management but will also demonstrate how these elements directly affect the quality of medical device projects. Attend to gain a valuable edge in driving your projects to successful completion.

Enroll Now!

Areas Covered

  • 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

BONUS:

  1. PDF copy of the presentation handout for your future reference.
  2. Soft copy of the certificate of completion on request.
  3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
  • 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

BONUS:

  1. PDF copy of the presentation handout for your future reference.
  2. Soft copy of the certificate of completion on request.
  3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Who is this course for

Reap the Rewards of This Training Individually or as a Group for Collective Growth!

  • Research and Development (R&D) Professionals
  • Product Managers in Medical Device Companies
  • Regulatory Affairs Specialists
  • Quality Assurance and Quality Control Managers
  • Clinical Operations Managers
  • Engineering and Manufacturing Professionals
  • Cross-Functional Team Members in Medical Device Projects
  • Anyone Interested in Excelling in Medical Device Project Management

Reap the Rewards of This Training Individually or as a Group for Collective Growth!

  • Research and Development (R&D) Professionals
  • Product Managers in Medical Device Companies
  • Regulatory Affairs Specialists
  • Quality Assurance and Quality Control Managers
  • Clinical Operations Managers
  • Engineering and Manufacturing Professionals
  • Cross-Functional Team Members in Medical Device Projects
  • Anyone Interested in Excelling in Medical Device Project Management

Instructor Profile

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance and compliance-related problems.

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance and compliance-related problems.

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