Date :
Place : United States, Arlington
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.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
Check the event website for more details.