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Thursday, December, 14, 2017
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Online Conference Biotechnology : Ensuring Data Integrity and Safety in Clinical Research
Overview:  Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11. Why s...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : The Value of a Human Factors Program
Overview:  This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program. Why s...
Concerned sectors: Biotechnology -Medical Informatics -
Online Conference Biotechnology : Clinical Data Systems Regulated by FDA
Overview:  Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.Certain documents, content and images related to a clinical trial ...
Concerned sectors: Biotechnology -Medical Informatics -
Online Conference Biotechnology : Which data and systems are subject to Part 11
Overview:  This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructur...
Concerned sectors: Biotechnology -Medical Informatics -
Online Conference Biotechnology : To Facilitate a Closed-Loop Problem Resolution System
Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations. Why should you Attend: Expectations for mean...
Concerned sectors: Biotechnology -Medical Informatics -
Online Conference Biotechnology : Excel - Benefits and Hazards in Office 365
Overview:  In this valuable presentation, Excel expert David Ringstrom, CPA, explains how the Office 365 version of Excel 2016 differs from previous versions and perpetual licensed versions of E...
Concerned sectors: Biotechnology -Medical Informatics -
Online Conference Biotechnology : Products Used in Early Phase IND Studies
Overview: How it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session: Discussion of the elements found in the guidance document ...
Concerned sectors: Biotechnology -Medical Informatics -
Online Conference Biotechnology : How software requirements are used in validation
Overview: This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing. Why should you Attend: Testing software to prove th...
Concerned sectors: Biotechnology -Medical Informatics -
Online Conference Biotechnology : Aware of the Similarities and Differences in the files
Overview:  It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification s...
Concerned sectors: Biotechnology -Medical Informatics -
Online Conference Public Health : FDA regulations and the ICH GCP recommendations
Overview: It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Pro...
Concerned sectors: Public Health -
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