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Latest FDA Changes to the Process Bullet Proof 510k - 2017
Other Services Fremont (One Dial-in One Attendee Price: US$150.00) May 15, 2017 FreeOverview: The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Objectives: Know the differences between the Traditional, Special and Abbreviated submissions Understand...
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The Marriage of the PFMEA and Control Plan Web Conference by Compliance4all
Other Services Online (California) November 11, 2016 150.00 Dollar US$Overview: Come celebrate the union of the PFMEA and the CP! See how the Dynamic Control Plan (DCP) combines both tools into ONE enabling the savings of hundreds of hours of Engineering time, reducing the risk of documentation errors, and, actually im...
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Effective Training Practices for FDA Compliance Web Conference by Compliance4all
Other Services Online (California) November 11, 2016 150.00 Dollar US$Overview: No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspecto...
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Device Changes, FDA Changes, and the 510(k) Web Conference by Compliance4all
Other Services Online (California) November 11, 2016 150.00 Dollar US$Overview: 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 ...
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Chemistry 101 for Medical Device Regulatory Web Conference by Compliance4all
Other Services Online (California) November 11, 2016 150.00 Dollar US$Overview: Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect...
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FDA Regulation of Combination Products Web Conference by Compliance4all
Other Services Online (California) November 11, 2016 150.00 Dollar US$Overview: A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Why Should you Attend: To gain a fundame...
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Sampling Plans for Risk Management in Incoming QC Web Conference by Compliance4all
Other Services Online (California) November 11, 2016 150.00 Dollar US$Overview: The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are pr...
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The Investigational Medicinal Product Dossier Web Conference by Compliance4all
Other Services Online (California) November 11, 2016 150.00 Dollar US$Overview: This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an F...
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Compliance with FDA and ISO Requirements Web Conference by Compliance4all
Other Services Online (California) November 11, 2016 150.00 Dollar US$Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regar...
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The New FDA-Product Approval Web Conference by Compliance4all
Other Services Online (California) November 11, 2016 150.00 Dollar US$Overview: The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration. The new commissioner recently announced a new policy for Warning Letters and FDA-483 responses, putting ma...
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Understanding Autism Spectrum Disorder Web Conference by Compliance4all
Other Services Online (California) November 11, 2016 150.00 Dollar US$Overview: This is an interactive overview of how DMAIC can be utilized in a home environment to improve the quality of life for a child diagnosed as being on the Autism Spectrum. Why should you Attend: Why One in every 68 children is now diagnosed wi...
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Analysis Of Extremely Non-normal Data Web Conference by Compliance4all
Other Services Online (California) November 11, 2016 150.00 Dollar US$Overview: Reliability Plotting is a graphical technique that is a standard method described in some reliability textbooks. The method is used primarily for data that is problematic in one or more of the following ways: non-normal. Why should you Atte...
