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Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada  

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training seminars by ComplianceOnline ComplianceOnline

Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada seminar agenda print utility

dates/locations

For:

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

Cost:   

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Seminar Summary:

In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada. (see full course description)

 

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Training Course Syllabus:


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.

Seminar Summary:

In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada. (see full course description)

 

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