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

Date : 27th September 2017 to 28th September 2017

Place : Switzerland, Zurich

Website :https://www.eventbrite.com/e/data-integrity-fdaeu-requirements-and-implementation-ntz-tickets-34480744836?aff=NDT

Contact Person:Paula Edwards

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

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 will be held in Zurich,Switzerland on date 2017-09-28

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Deadline for abstracts/proposals : 8th September 2017

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. Presenter of the Year of the Institute for Validation and Technology

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 Be able to specify and validate Part 11 compliant software functionality

Venue :8152 Opfikon, Switzerland

Check the event website for more details.