In Vitro Diagnostics Product Development
BIOL-40244
In Vitro Diagnostics Product Development
As biotech and In Vitro Diagnostics (IVD) companies mature, the need for professionals with a broad understanding of the skills required to be effective in a biological product development environment will increase. In this course, learn the requirements for moving an IVD product from concept to regulatory approval and market launch. Topics include planning for success by setting product requirements & specifications to meet customer needs, critical path management, resource planning, principles of assay development, instrumentation, role and composition of the product development team, risk analysis, and IVD clinical and regulatory issues including compliance and complaint handling. Specific product development cases will be discussed.
This course is a live online experience conducted through Zoom. You'll need to log in at the scheduled time to join discussions and complete assignments.
Who Should Attend
This course is designed for managers, entrepreneurs, investors and scientists seeking an overview of the regulatory, clinical, scientific and business aspects of In Vitro Diagnostic product development.
Course Agenda
This course will use Zoom conference call technology instead of traditional classroom meetings. Please see below for course dates and times.
Session 1
- Introduction to the IVD World
- Package Insert – Begin with end in mind
- Business Case (NPV, IRR, Standard Costs)
Session 2
- Design Control
- Customer Input and Product Requirements
- Product Risk Analysis
- Product Development Process and Resource Planning
Session 3
- Group Assignment and Breakout
- Case Study 1 - ex: DNA sequencing
- Case Study 2 – ex: COVID
Session 4
- Principles of Assay Development
- Companion Diagnostics
Session 5
- Group Assignment and Breakout - Companion Diagnostics
- Instrumentation/ Software in IVD
Session 6
- Design and Conduct of Preclinical and Clinical Trials
- Regulatory Overview
- Exam Review
Speakers:
- Larry Mimms, PhD, Principal, LTM Enterprises
- Valerie Day, MS, MBA, Medical Device Consultant
- Damon Getman, PhD, Scientific Director, Medical and Scientific Affairs, Hologic, Inc.
- Al Maderazo, VP, Quality Assurance and Regulatory Affairs, GenMark Diagnostics
