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

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1
Biostatistics for the Non-Statistician
23 Jul 2020 - 24 Jul 2020 • San Francisco, CA, United States
Organizer:
Complianceonline
Abstract:
Statistics is a useful decision-making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
biostatistics for the non-statistician seminar, p-values, common statistical tests, bayesian logic, diagnostics testing, statistical analysis plan (SAP)
Event listing ID:
1353127
2
Life Science RIMS- Regulatory Information Management Systems
24 Aug 2020 - 25 Aug 2020 • New Jersey, United States
Organizer:
Lincoln Health Network
Abstract:
Life science organization have management systems for clinical trials, patient’s data, and thousands of other different products, but when it comes to regulatory documents they can be stored in multiple areas. However with a strategic RIMS process and system you will be able to collect and store all of your documents in one platforms which will maximize information work flows across the entire organization.
Contact:
Information on Event;     Phone: [619-597-7315];     Email: jessica@gsmiweb.com
Event listing ID:
1349410
3
Analytical Instrument Qualification and System Validation
17 Sep 2020 - 18 Sep 2020 • Philadelphia, PA, United States
Organizer:
Complianceonline
Abstract:
Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance. Recent EU and FDA reports demonstrate that qualification, validation and electronic records are priority areas for inspection. The large number of FDA warning letters and the frequency of EU enforcement action in these areas demonstrate that companies sometimes struggle to understand or implement the regulations. This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national and international regulatory bodies. The course not only ensures a full understanding of the regulations and guidelines for equipment and records but helps attendees to develop a risk-based approach to compliance. Interactive exercises will be dispersed into and between the presentations.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
Computer System Validation seminar, USP <1058>, GAMP 5, equipment calibration, system validation, qualification and validation strategy, archive raw data from hybrid systems, Analytical Instrument Qualification, USP General Chapter <1058>, instrument qualification lifecycle, 21 CFR Part 211, Part 11, PIC/S, EU Annex 11, GMP Computer Systems, Laboratory Computerized Systems, Use of Excel in QC Laboratory, revalidation of chromatography, data security and integrity issues
Event listing ID:
1345724
4
AMIA 2020 — AMIA 2020 Annual Symposium
14 Nov 2020 - 18 Nov 2020 • Chicago, United States
Abstract:
We invite you to contribute your best work for presentation at the AMIA 2020 Annual Symposium – the foremost symposium for the science and practice of biomedical informatics.
Event listing ID:
1331095


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Last updated: 28 April 2020