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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 -
Training Medical Informatics : FDA Trends for CSV Compliance and Enforcement | Boston Seminar 2018
Course "FDA Trends for Computer System Validation (CSV) Compliance and Enforcement" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertifica...
Concerned sectors: Medical Informatics -
Training Medical Informatics : New EU Medical Device Regulation | Updated Regulation 2018
Course "The New EU Medical Device regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview...
Concerned sectors: Medical Informatics -
Online Conference Public Health : How can companies allocate scarce resources
Overview: This webinar will help you understand the critical ingredients for conducting an effective root cause analysis, also you will learn how to Analyze and document the root cause of the p...
Concerned sectors: Medical Informatics -Public Health -
Online Conference General Medicine : How to Correctly Submit Pharmacogenomics Data for Faster Approval by the Agency, and What to Expect from the Regulatory Agencies in the Near Future
Overview: This presentation, will describe the agency expectations, describe how to correctly submit pharmacogenomics data for faster approval by the agency, and what to expect from the regu...
Online Conference Biomedical : 3 hour Virtual seminar on FDA's New Enforcement of 21 CFR Part 11
Overview: FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 relat...
Online Conference Biomedical : 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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 ...
Online Conference Biomedical : Non-Conforming Material and Failure Investigation
Overview: Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-confo...
Online Conference General Medicine : Process Validation Requirements & Compliance Strategies
Overview: This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process...
Online Conference Biomedical : 3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements
Overview: This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and...
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