Conference Details

This new two-day course provides the regulatory background and guides attendees through the complete record lifecycle from data entry or acquisition through evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA's Part 11 and the EU/PICS Annex 11.

Date :

Place : United States, Arlington

Website :

Contact Person:Paula Edwards

Description:

This new two-day course provides the regulatory background and guides attendees through the complete record lifecycle from data entry or acquisition through evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA's Part 11 and the EU/PICS Annex 11.

This new two-day course provides the regulatory background and guides attendees through the complete record lifecycle from data entry or acquisition through evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA's Part 11 and the EU/PICS Annex 11. will be held in Arlington,United States on date 2017-10-13

Deadline for abstracts/proposals : 5th October 2017

Organized By :New York Events List

Keynote Speakers : Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Labcompliance Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.

Conference Highlights :Understand what data integrity is and why it is so important for public health Learn why there are so many data integrity issues Learn about the FDA/EU/PICS/MHRA/WHO requirements for data integrity Understand how to define and archive raw data from hybrid systems: electronic vs. paper

Venue :Arlington, VA 22202, United States

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This new two-day course provides the regulatory background and guides attendees through the complete record lifecycle from data entry or acquisition through evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA's Part 11 and the EU/PICS Annex 11.

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