Data Integrity: FDA/EU Requirements and Implementation

Course Description:

There is no doubt that data integrity is the current and future inspection focus of all regulatory heath care agencies. More than 50% inspection reports such as 483's and Warning Letters quote data integrity as deviations from GxP regulations.

This new 2-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.

Learning Objectives:

Attendees will:

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

Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11

Understand FDA's New and ongoing Part 11 inspection and enforcement practices

Who will Benefit:

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

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/data-integrity-fda-eu-requirements-and-implementation-seminar-training-80384SEM-prdsm?channel=sciencedz