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Colloquium Medical Informatics : Medical Device Software: An Incremental Approach to Risk and Quality Management
Course "Medical Device Software: An Incremental Approach to Risk and Quality Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recert...
Concerned sectors: Medical Informatics -
Online Conference Nursing : Computer System Validation 2018 Fundamentals
Overview: FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device softwar...
Concerned sectors: Biomedical -Nursing -
Congress Biomedical : Applied Statistics for Scientists and Engineers seminar at Boston
Description: Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting valid...
Concerned sectors: Biomedical -Medical Equipment -
Conference / Seminar Biomedical : Validation Sampling Plans for Process Validation [Latest]
Overview: Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation How to identify when sampling plans...
Concerned sectors: Biomedical -Biotechnology -
Tags: Education
Conference / Seminar Biotechnology : Record Keeping Best Practices [FDA and EMA] Documentation
Overview: Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion in...
Concerned sectors: Biotechnology -Public Health -
Conference / Seminar Biomedical : Business Continuity Planning for [Computer Systems] Operations
Overview: Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharm...
Concerned sectors: Biomedical -Biotechnology -
Conference / Seminar Biotechnology : Quality by Design - Essential Techniques for Medical Devices
Description: Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of th...
Concerned sectors: Biotechnology -Medical Equipment -
Colloquium Biotechnology : Excel Spreadsheet Validation 2018 Tools and Techniques
Description: Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the cr...
Concerned sectors: Biotechnology -Medical Informatics -
Conference / Seminar Biotechnology : Introduction to Adaptive Design for Clinical Trials
Description: This 2-day seminar includes an overview of Adaptive Design, and an emphasis in group sequential design, sample size re-estimation, and Phase II/III Adaptive Seamless Designs. The role o...
Concerned sectors: Biotechnology -
Conference / Seminar Biotechnology : Data Integrity in Clinical Trials in [Latest methods]
Overview: The clinical data recording process, however, as inspected/audited by inspectors/auditors is initiated with the recorded data, either in the Case Report Form, or in some other system, or in...
Concerned sectors: Biomedical -Biotechnology -Public Health -
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