Laboratory Accreditation: Getting there is just the beginning

Overview:  Many laboratories struggle with developing and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Once accreditation has been achieved many laboratories have difficulty maintaining the QMS as evidenced by the number of non-conformances cited during the subsequent biannual audits.Areas Covered in the Session:Defining a Quality..

  • 2 Months ago
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Accelerated Aging Techniques for Medical Device Packaging

Overview:  Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.Why should you Attend: Accurate prediction of product shelf-life performance is critical to your success. "Do it rig..

  • 2 Months ago
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FDA's Medical Device Clinical Trials Program in 2016 by Compliance4all

Overview:  The yearly payment volumes - B2B only - of processors such as CHIPS, Fedwire, SWIFT, and ACH are growing steadily, while checks are declining at a small single-digit rate.Businesses of all sizes are trying to send payments in the most cost-effective way and not necessarily through the bank- established channels. Corporate financial professionals want a conversion from paper to electronic payments, but only if they can get the payment informatio..

  • 8 Months ago
  • 304 Views
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Electronic Health Records Software License Agreements 2016

Overview: For physician practices just setting foot into the EHR arena, and for those practices transitioning to a new EHR software package, the fundamental document controlling their experience will be the EHR license agreement. The license agreement will -- or should -- determine issues such as how whether and how often the vendor may make online portions of the software unavailable for maintenance or other issues; how many people may use the software a..

  • 8 Months ago
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Webinar on HIPAA for Dummies Boot 2016

Overview: This lesson is going to get back to the basics using multiple real life scenarios and "what if's". My goal is to make this very confusing and not well explained law easy to understand for the typical staff member. I will uncover myths versus reality as it relates to this enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also point ..

  • 8 Months ago
  • 278 Views
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Statistics for the Non-Statistician Seminar

Overview:   Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. And of course, with statistics, practice makes perfect. During this two-day HIGHLY interactive training p..

  • 8 Months ago
  • 207 Views
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Conference on Implementing ISO 13485:2016 in Boston

Overview: The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation.  This workshop covers the differences from the 2003 v..

  • 8 Months ago
  • 202 Views
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Seminar on Medical Devices Design Controls

Overview: Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2 days seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company. Intrinsic quality, safety, and effectiveness of a device are k..

  • 8 Months ago
  • 157 Views
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Latest FDA Proposed Changes to the Process and Bullet Proof 510(k) Seminar

Overview:   This Two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and A..

  • 8 Months ago
  • 133 Views
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Sex buyers are more likely to commit rape than others

Men who buy sex are more likely than others to report having committed rape and other aggressive sexual acts, and they show less empathy for prostitutes, according to a study. According to the researchers behind the work, buying sex is a basically predatory practice that shouldn't be legalized. They are backing ...

  • 1 Years ago
  • 437 Views
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