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Device Changes, FDA Changes, and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". Live Wednesday, May 22, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $245.00
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Key Concepts in Successful Water System Sanitization
Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization chemical choices and how they are used, as well as the frequency of the sanitization process have everything to do with its success. Live Thursday, May 23, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $225.00
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FDA 510(k): Preparation, Submission, and Clearance
This webinar is intended to demonstrate how to prepare a 510(k), submit, and get it cleared in a manner with increased quality so that the review process can be expedited. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices. Live Thursday, May 23, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $225.00
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Global Medical Device Adverse Event Reporting Systems in EU, Canada and US
Medical device firms' obligation doesn't end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable. Live Tuesday, May 28, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $225.00
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Device Corrections and Removals
When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA? Live Tuesday, May 28, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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Medicaid Vs. Medicaid EHR Incentives & Meaningful Use Certifications in US
An electronic health record (EHR) allows providers to record patient information electronically instead of using paper records. The EHR Incentive Program asks providers to use the capabilities of the EHRs to improve patient care. Live Wednesday, May 29, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $225.00
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PCI DSS: Tips and Trends for 2010 Compliance to the PCI DSS can be an overwhelming task in the beginning. The requirements are specific and if your organization has not had an information security program in place, there may be a lot to do to meet minimum compliance requirements. Recorded Thursday, May 13, 2010 11:00 AM PST | 02:00 PM EST, Duration:60 Minutes $215.00
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Management Review: The Complete Requirements One of the main elements to a fully implemented Quality Management System (QMS) is the Management Review. Recorded Thursday, May 13, 2010 11:00 AM PST | 02:00 PM EST, Duration:60 Minutes $295.00
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Statistical Process Control and Trending Analysis There are several methods to trend data to highlight both the preventative and corrective nature of the system. Recorded Tuesday, May 11, 2010 10:00 AM PST | 01:00 PM EST, Duration:60 Minutes $295.00
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Development and Audit of Complaint Handling and MDR Processes Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. Recorded Thursday, May 6, 2010 10:00 AM PST | 01:00 PM EST, Duration:60 Minutes $295.00
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Webinar on Allergen control Allergens under regulatory control are limited to 8. However, they take on many names and forms. Identifying and avoiding these allergens are an important strategy for manufacturers as well as consumers. Recorded Thursday, April 29, 2010 10:00 AM PST | 01:00 PM EST, Duration:60 Minutes $215.00
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Contract Manufacturing - it requires more than you think to do it right Overseeing your contract manufacturer is a skill that is better learnt before you make a single dose rather than on the job. Recorded Wednesday, April 28, 2010 10:00 AM PST | 01:00 PM EST, Duration:60 Minutes $295.00
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