Date :
Place : Switzerland, Zurich, switzerland
Contact Person:Eevnt Manager
Description:
There is no doubt that data integrity is the current and future inspection focus of all regulatory health care agencies. More than 50% inspection reports such as 483's and Warning Letters quote data integrity as deviations from GxP regulations. 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 : 25th September 2017
Organized By :NetZealous DBA as GlobalCompliancePanel
Keynote Speakers : 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. Presenter of the Year of the Institute for Validation and Technology Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. Author of the books &
Conference Highlights :QA managers and personnel Laboratory managers and supervisors Production managers and supervisors Analysts IT/IS managers and system administrators Software developers Regulatory affairs Training departments Documentation departments Consultants
Venue :Zürich, Switzerland
Check the event website for more details.