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Compliance 4 All presents

 Introduction to Project Management for Medical Instrument Development Webinar

In this webinar we will discuss the main elements of project management for medical Instrument Development to deliver the project on time, within budget, and in compliance with these regulations, It covers simple and small projects to mid-size projects including development projects and manufacturing projects.

Course Description/Agenda

This is an introduction to project management for medical device development targeted to new project managers or lead engineers that find they need to manage their own projects. It covers simple and small projects to mid-size projects including development projects and manufacturing projects.

The biggest contribution to a successful project is getting a team that buys into the plan and is committed to the dates and budget established. We will discuss how to get buy in from all the team members, how to monitor and drive progress to meet goals and commitments.

Why should you Attend: There are several key elements that need to be included in your instrument development project to ensure compliance with FDA and EU IVDR (In-Vitro Diagnostics Regulation). The new regulations have added many new requirements that translate to new deliverables your project must provide.

We will discuss the main elements of project management for medical Instrument Development to deliver the project on time, within budget, and in compliance with these regulations.

Areas Covered in the Session:

• Project Phases
• Establishing Project scope
• Defining the Stakeholders
• Building a team
• Building a schedule
• Building a project budget
• Types of project risks
• Managing and monitoring the project progress

• Project Managers
• Quality Managers
• Quality Engineers
• Quality Scientists
• Regulatory Affairs teams
• Lead Engineers
• Device Development teams
• Manufacturing engineers

Instructor:

Robert (Bob) Uleski has developed and led projects over the past 40 years for 11 clinical chemistry systems, 5 immunoassay systems, 2 hematology automated analyzers, and 3 laboratory data management systems. He was chairman of the Connectivity Industry Consortium’s Device Messaging Layer committee and has been actively involved in the CLSI POCT1-A: Point of Care Connectivity and AUTO9-A: Remote Access to Clinical Devices from the Internet. He has served on the ASTM committees for Computerization of clinical data and Laboratory Interface Standards and been a member of the ANSI Healthcare Informatics planning panel. Most recently he was a program manager at Beckman Coulter Inc. and has also consulted on Optics, Software, and Software Validation. Currently he leads programs for IVDR and REACH remediation.

 

More Webinar Information

Compliance 4 All Course Summary In this webinar we will discuss the main elements of project management for medical Instrument Development to deliver the project on time, within budget, and in compliance with these regulations, It covers simple and small projects to mid-size projects including development projects and manufacturing projects. Delivery Method  Virtual Classroom (Live) Who Should Attend • Project Managers • Quality Managers • Quality Engineers • Quality Scientists • Regulatory Affairs teams • Lead Engineers • Device Development teams • Manufacturing engineers

 

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