Date: September 21st, 2023
Time: 17:30-18:30 PM CEST | 11:30 AM - 12:30 PM EST | 8:30 - 9:30 AM PST
Location: Virtual
Language: English
Introduction:
Analytical and Clinical Performance for IVDs | Good Science to Meet Regulatory Expectations for IVDs
Intro
In-vitro diagnostics can appear to be even more challenging than “rocket science”, but the reality is that we just need good science. This webinar will explore the tools of design control, as well as touches on how we use good science before we step into the lab to lay out what the design needs to achieve given the intended use we want to claim.
In this webinar, attendees will learn ways to:
- Use the design control elements to help them organize and manage the work that needs to be done to develop an IVD product.
- Understand how the analytical studies are related to the accuracy claim for the product.
- Use the required accuracy for the product to determine the acceptance criteria for the analytical studies.
This webinar aims to help you by sharing the following:
- Walks through the elements of design control
- Compares the elements of design control between US 21CFR 820 and ISO 13485
- Reveals the “one metric to rule them all
- Discusses why we need to conduct analytical studies and how they are related to accuracy claims we want to make about the product.
Learning objectives
- Learn about the purpose of Design Controls and regulatory requirements based on 21 CFR 820 Quality System Requirements and ISO 13485.
- Understand the importance of Design Controls as part of QMS and the important elements of Design Controls.
- Understand how good science is used to determine analytical study acceptance criteria.
Who should attend?
- IVD Professionals
- Regulatory specialists, experts, managers, directors
- QA specialists, experts, managers, directors
- Project managers
- Managers with strategic decision making
Start-ups
The free webinar closes with a Q&A, which is often a popular part of our webinars, so we encourage you to send in questions prior to the webinar, and we will cover as many as possible. Use the registration form to send in questions, use the Questions Tab during the webinar, or mail them beforehand to marketing@qservegroup.com.
Presenters: