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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 : A Risk Based Approach to IT Infrastructure & Cloud Qualification, Compliance & Control
Course "A Risk Based Approach To IT Infrastructure & Cloud Qualification, Compliance & Control" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant&#...
Concerned sectors: Medical Informatics -
Training Medical Informatics : Writing & Managing Effective SOPs Seminar 2018
Course "Writing & Managing Effective SOPs" 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 -
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 : How to Register and Maintain Various Types of Combination Products | Seminar 2018
Course "Combination Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This seminar pr...
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 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 Medical and Hospital Management : Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan....
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 ...
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