Meetings/Workshops on Clinical Data Management, e-Health in the United States (USA)

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1
HDSSH — Health Data Science Symposium at Harvard
05 Nov 2021 • Boston, United States
Organizer:
Computational Neuroscience Outcomes Center, Harvard Medical School
Abstract:
We’re excited to invite you to the 3rd annual Health Data Science Symposium at Harvard (website) hosted by faculty from Brigham & Women’s Hospital/Harvard Medical School & the Harvard School of Public Health, to take place Friday, Nov 5th, 2021 in Boston. Currently, the symposium will be in-person & socially-distanced with virtual attendance options. However, should public health guidelines change, the symposium will become fully virtual. The 2021 focus is on Digital Phenotyping, Wearables, Smartphones, & Personal Sensing across Health. The symposium brings together leading experts for a day of talks, abstract presentations, and collaborative networking around state-of-the-art advances across academia and industry in the health data sciences.
Contact:
Phone: [6175258113];     Email: nnawabi@bwh.harvard.edu
Abstract submission deadline:
05 Oct 2021
Event listing ID:
1446392
2
21 CFR Part 11 - Compliance for Electronic Records and Signatures
29 Sep 2022 • online, United States
Organizer:
compliance4all
Abstract:
Overview:

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.

The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained. FDA requirements for 21CFR Part 11 validation will be explained. the requirements are composed of technical and procedural aspects. open, closed and hybrid (paper and electronic) systems will be explained.

Contact:
Compliance4all;     Phone: [8004479407];     Email: support@compliance4All.com
Event listing ID:
1368470
Related subject(s):


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Last updated: 29 September 2021