Webinar Series on Data Integrity: Data Integrity from the view of a GMDP inspector

Monday, 5 October 2020 14.00 - 16.00 h

Course No 18187

Important: Registration Deadline is 09.00 h on 5 October 2020. All times mentioned are CEST

You will find all webinars of this series in this overview.

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Franz Schönfeld, District Government of Upper Franconia

Background

Data Integrity is still a major concern with both the FDA and European Regulatory Agencies. Many FDA warning letters and EU GMP inspections have highlighted major data integrity failures at companies worldwide. Data integrity is not a new topic: The principles apply to electronic and to paper-based systems. Major topics cover

IT Security, System and Data Integrity
Written Policies
Data Life Cyles
Principles of ALCOA+
Handling of Raw Data Review of Data

As electronic date is widespread in Quality Control but also in Production it is getting more and more interest of GMDP inspectors.

Target Group

This webinar is addressed to employees of pharmaceutical manufacturers, authorities and suppliers with responsibility in

Quality assurance
Production
Quality Control
Inspections and Audits

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Major objectives of this webinar are as follows:

Basic Regulatory Requirements
IT Security and User Management
Handling of Data (including Raw Data)
Data Integrity
Examples (Production and Quality Control)
Inspection Findings

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