Tagungen und Workshops zum Thema Klinisches Datenmanagement, E-Health

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ALLE LÄNDER (3)
1
Pharma Micro UK — SMi's 10th Annual Pharmaceutical Microbiology UK Conference
18. Jan 2021 - 19. Jan 2021 • London, Großbritannien
Veranstalter:
SMi Group
Zusammenfassung:
SMi’s flagship microbiology conference is celebrating its 10 year anniversary. The conference taking place on 18 and 19 January 2021 in London, UK will bring together industry experts to explore agile contamination control strategy’s that tackle the most pressing challenges and push innovation in the world of pharmaceutical microbiology. The two-day event will address Contamination Control Strategies, Effective Environmental Monitoring, and the newest schools of thought in personnel operation. Leaders in regulation and compliance will provide expert consultant’s viewpoints on how to implement and interpret the regulation. Also Annex 1 will be assessed and prepared for. All of this is to be presented with current case studies.
Kontakt:
Tel.: [02078276000];     Email: ssapal@smi-online.co.uk
Themen:
Pharmaceutical, microbiology, contamination, microbial, biofilms, sterility, quality assurance, mycoplasma, data integrity, microbiome, Endotoxins
Eintrags-ID:
1377535
2
CIRM – Research School — Dynamics and Statistics of Cancer Evolution : Applying Mathematics to Experimental and Clinical Data
05. Jul 2021 - 09. Jul 2021 • CIRM (Marseille Luminy), Frankreich
Veranstalter:
CIRM – Centre International de Rencontres Mathématiques
Eintrags-ID:
1312386
Verwandte Fachgebiete:
3
21 CFR Part 11 - Compliance for Electronic Records and Signatures
29. Sep 2022 • online, Vereinigte Staaten
Veranstalter:
compliance4all
Zusammenfassung:
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.

Kontakt:
Compliance4all;     Tel.: [8004479407];     Email: support@compliance4All.com
Eintrags-ID:
1368514
Verwandte Fachgebiete:


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Stand vom 21. September 2020