Data Analysis in QSR - Online Webinar

Tuesday, Mar 21, 2017 at 10:00AM - 1:00PM

Event Details

Data analysis is one of the most powerful improvement tools because it can lead to cost reductions and preventive action. To use these techniques you need to know both the regulatory requirements and the analysis framework. This presentation provides that essential information.

Objectives Of The Presentation
  • Learn the difference between corrective action and preventive action - a pervasive problem
  • Understand the requirements from QSR and the expectations FDA set
  • How to pick the appropriate data analysis techniques from ISO/TR 10017:2003
  • Use the GHTF guidance document to design and implement your improvement program
  • Review FDA Warning Letters that illustrate the issues device manufacturers face
Why Should you Attend
Corrective and Preventive action is the most frequently cited section in device Warning Letters and data analysis is the most frequently cited subsection. This suggests that device manufacturers need to understand FDA’s expectations and meet them with a robust approach to data analysis. However, data analysis is more than a regulatory requirement. It is an effective method for a device manufacturer to identify problems, analyze their causes, and take action. These activities can reduce cost and increase customer satisfaction. For example, a Warning Letter points out that 17% of complaints were returns for shipping the wrong product. It concludes, "This [problem] was not identified, no investigation was performed, and no corrective action was taken."

With the appropriate framework and analysis tools, the company could have found the problem, eliminated the cost and prevented the customer dissatisfaction. Instead, an FDA Investigator uncovered the issue; now the company must take additional action (and allocate resources) to address the Warning Letter.

This presentation helps you understand the issues and take action. For example, some companies believe there is a requirement to ‘trend’ the data. However, FDA-CDRH says that is only one tool among the many statistical analysis techniques. You will learn about a recommended set of techniques and why trending is only among many viable methods.

The Global Harmonization Task Force has a guidance document that provides a framework for implementation. The webinar covers this framework and explains how you could use it to implement an effective system.

Who will Benefit
  • Senior management
  • Regulatory affairs
  • Quality assurance
  • Production
  • R&D and engineering
  • Data analysts
For Registration

Note: Use Promo code PTY2D and get 10% off on registration (Valid till MARCH 31st 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 March 21, 2017 at 10:00AM - 1:00PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896