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2020 - FDA 21 CFR Part 11



Venue2035 Sunset Lake, RoadSuite B-2, Newark, Delaware - 247compliance, USA - United States USA - United States

KeywordsFDA Compliance


Topics/Call fo Papers

This webinar will introduce best practices in electronic recordkeeping for the Pharmaceutical, Medical Device, and other human health sectors. We will discuss best practices that can be established before the point of data collection and throughout data storage and maintenance to ensure compliance according to FDA 21 CFR Part11. This webinar is suitable for all partners and stakeholders at any stage of data collection, retention, or transmission.
Any electronic data in the medical or pharmaceutical fields, whether collected for treatment or research purposes, must be collected and maintained to rigorous standards for privacy and accuracy. Recordkeeping processes must be in compliance with applicable regulations, and the time for establishing those processes for your company or practice is well in advance of any data collection.
This webinar will describe best practices for collecting, using and storing electronic records and samples. We will pay particular attention to the requirements set forth by FDA 21 CFR Part11, a longstanding Federal Drug Administration (FDA) regulation often used as a benchmark by health industry data specialists.
Data is the liquid gold of today's economy. The costs of mishandling, losing, leaking, or otherwise circumventing best practices, and industry regulations for data can be devastating, for both reputation and the bottom line. Failure to gather necessary permissions from the original owner and provider can affect liability and data integrity.
Whether your role involves;
Collecting (e.g.: from study nurse to x-ray specialist)
Using and creating (e.g.: from sponsor to report programmer, or statistician or GP)
Keeping (e.g.: from coder, software provider, to server and backup specialist)
This webinar will address your questions about how important your part is in this process loop, and how you can help the company safeguard resources and remain fully compliant.
Overview and definitions
Why data collection and storage processes are so vital?
The relationship between the four “partners” related to data: owner and provider; collector; user and creator; and keeper
The forgotten loop: a fully transparent data sequence initiated and terminated by the patient
Common mistakes and today's problems (including “Big Data”)
Best practices or the ideal process
Clinical study key personnel
Clinical data managers and scientists
Laboratory personnel
QC/QA managers and analysts
Information Technology analysts, developers, and testers
Computer system validation specialists
Regulatory Affairs personnel
Consultants in the Life Sciences and Health Industries
Anyone with a professional interest in increasing knowledge and awareness of Data Privacy, Data Protection, and Data Integrity
Willi Ramseier is currently the owner and director of QVRAM GmbH of Basel, Switzerland. As an expert in quality assurance, system validation, risk awareness, and management, Ramseier is a reputed trainer, mentor, and quality compliance officer.
For more detail please click on this below link:
Tel: +1-(510)-868-1040

Last modified: 2019-12-23 19:01:11