Regulatory Challenges Facing In-Vitro Diagnostic in U.S.-OnlineWebinar

Thursday, Apr 27, 2017 at 10:00AM - 1:00PM

Event Details

In-vitro diagnostic (IVD) products drive a significant portion of clinical decision making today. IVDs assist in the identification, diagnosis and monitoring of disease. They play an ever-expanding role in the selection of appropriate therapeutic interventions in healthcare delivery with the advent of personalized medicine. These key products are a distinct class of medical devices regulated in the US by the Food and Drug Administration (FDA).

Objectives Of The Presentation
  • Discuss the current state of IVD regulations in the US and other regions
  • Identify and explain areas of IVD regulations related to:
    • product classification
    • IVD development, testing and premarket submission
    • post market regulatory maintenance and responsibilities for IVD manufacturers
  • Identify potential future challenges facing IVD manufacturers
  • Discuss IVD technologies and emerging trends
  • Apply IVD-specific regulations and guidelines for successfully traversing regulatory hurdles
Why Should you Attend
This course provides an overview of in vitro diagnostic medical devices with a focus on FDA's regulatory requirements. It introduces key regulations and guidelines necessary for effective product development, explains what IVDs are and describes development and testing, getting a product to market, product review and FDA submission requirements.

Areas Covered
  • Introduction
  • Focused Oversight
  • Risk-Based, Phased-in Oversight
  • Evidence Standards
  • Third Party Review
  • Clinical Collaborative
  • Transparency
  • Modification
  • Quality System Requirement
  • Post market Surveillance
  • Conclusion
Who will Benefit
  • Clinical Laboratories
  • Cost Control Consultants for healthcare practice
  • Regulatory Affairs Managers for manufactures
  • Risk Managers for healthcare practices
  • Medical Device & Diagnostic Manufacturers
  • Practitioners using LDTs
  • Pathology practice groups
For Registration

Note: Use Promo code DE5YU and get 10% off on registration (Valid till APRIL 30th 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont 94536

Starts April 27, 2017 at 10:00AM - 1:00PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896