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SEARCH RESULTS : 17
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Thursday, September, 21, 2017
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Online Conference Biotechnology : Compliance for Computer Systems Regulated by FDA - 2017
Overview: The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Pa...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : Batch Record Review and Product Release - 2017
Overview: A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biolo...
Concerned sectors: Biomedical -Biotechnology -
Online Conference Biotechnology : Medical Device Engineering Change Control - 2017
Overview:  This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbe...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : Analytical Instrument Qualification and Validation Processes - 2017
Overview:  In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in ord...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : How to Develop the Risk Management File - 2017
Overview: The single most important element of medical device risk management is the Risk Management Plan (RMP). It ranges from Top Management's risk policy to review and approval of the Risk Man...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : 483 Covers a Broad Gradation of Problems
Overview: How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 c...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : NIST Cybersecurity Framework For Computer Systems Validation
Overview:  Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information...
Concerned sectors: Biotechnology -
Online Conference Biotechnology : Guidance on Software and Device Changes and the 510(k)
Overview:  The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. ...
Concerned sectors: Biotechnology -
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 -
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