Learning Objectives:

After completion of this two day interactive course on IVD, the attendee will be able to:

• Understand why IVD is regulated differently.
• An overview of IVD Regulations – U.S. FDA., Europe (MDD), Canada.
• Develop Regulatory Strategies and determine Regulatory Pathways.
• Inclusion and exclusion of data and information for different submission.
• Format and Content of premarket submissions.
• Product Label and Labeling for IVDs.
• Working and interacting with the reviewers and regulators.
• Tips and Suggestions to secure rapid regulatory approvals.

Who will benefit:

This interactive course is specifically developed for individuals, who are responsible for the design, development, manufacturing, marketing, and distribution of IVD products. This course is highly recommended for personnel involved in any of the following functions:

• Department Managers (middle management)
• Research & Development (R&D)
• Product Design & Development
• Validation Engineering
• Regulatory Affairs
• Quality Assurance
• Quality Control
• Manufacturing/Production