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.
Who Should Attend
This course is geared towards managers, entrepreneurs, investors and scientists seeking an overview of the regulatory, clinical, scientific and business aspects of In Vitro Diagnostic product development.
Due to circumstances stemming from COVID-19, this course will be offered in a live online format. This course will use Zoom conference call technology instead of traditional classroom meetings. Please see below for course dates and times.
- Introduction to the IVD World
- Package Insert – Begin with end in mind
- Product Development Process
- Resource Planning
- Design Control
- Customer Input, PRD
- Product Risk Analysis
- Case Study 1- DNA Sequencing
- Group Assignment and Breakout
- Business Case (NPV, IRR, Standard Costs)
- Case Study 2 – COVID
- Principles of Assay Development
- Companion Diagnostics
- Group Assignment and Breakout - Companion Diagnostics
- Instrumentation/ Software in IVD
- Design and Conduct of Preclinical and Clinical Trials
- Regulatory Overview
- Exam Review
- Larry Mimms, Ph.D., Chief Executive Officer, ProciseDX
- Tammy Brach, MBA, Director Program Management, Dexcom
- Valerie Day, MBA, Vice President, Product Development, ProciseDX
- Damon Getman, Ph.D., Chief Scientist, Diagnostics Scientific Affairs, Hologic
- Al Maderazo, VP, Quality Assurance and Regulatory Affairs, GenMark Diagnostics
Note: Due to circumstances stemming from COVID-19, this course will be offered in a live online format. This course will use Zoom conference call technology instead of traditional classroom meetings.
Course Number: BIOL-40244
Credit: 2.00 unit(s)