Test Method Validation to Verify your Device Performance-OnlineWebinar

Friday, May 05, 2017 at 11:30AM - 2:30PM
Fremont, CA
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$250.00 $8.62 20

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Event Details

Description
This webinar will help you have an understanding of Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case studies.

Objectives Of The Presentation
  • Test Method Validation - Overview
  • Quality System Regulation, 21 CFR Part 820, and ISO 13485 - Overview
  • When should Methods be validated?
  • Qualification vs Validation
  • Types of Test Method Validations
  • How to perform successful test method validations
  • How to ensure your inspection of verification is effective
  • Detailing real-life case studies
  • Understanding global reference standards for test method validation
  • FDA requirements for TMV
  • How to prove your inspection method is repeatable and reliable
  • Recommendations: Some Best Practices and Strategies
Why Should you Attend
Test method validation is an often confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples. Those who work with process optimization and validation focus on optimizing a process and reducing variability. Those working on Test Method Validation, on the other hand, focus on discerning between process variation and measurement error from the test method itself.

Often, the test method for a new process must be designed specifically for that process, and some of the pitfalls are in confounding the process itself with the test method. This webinar will present case-studies to explore how those issues are addressed.

Although the FDA provides guidance on method validation, the Code of Federal Regulations (CFR) Title 21 Part 820: Quality System Regulation (QSR) 21 does not specifically broach the topic of method validation. It alludes to it in equipment qualification, statistical methods, process validation, design controls, and other sections. In numerous warning letters, we have witnessed significant importance of method validation as an applicable medical device validation activity. Although, some traditional methods have been applied to chemical, microbial and laboratory acceptance testing methods, they are generally less utilized in the medical device industry.

Who will Benefit
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
  • Research & Development
  • Quality Engineers and Auditors
  • Manufacturing Engineers
  • Regulatory Affairs Teams
  • Quality Assurance & Quality Control Teams
  • Operations Teams
  • Document Control
  • Design Assurance Teams
  • Device Development Teams & Personnel involved in Verification and Validation planning, execution and documentation for devices.


For Registration

http://onlinecompliancepanel.com/webinar/TEST-METHOD-MEDICAL-DEVICE-508490/MAY-2017-ES-EZEVENT


Note: Use Promo code WE3PL and get 10% off on registration (Valid till MAY 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.

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Online Event
38780 Tyson Lane, Apt 210
Fremont, CA 94536

Starts May 05, 2017 at 11:30AM - 2:30PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896