Webinar: Auditing of Data Integrity - Approaches and Tipps

Webinar: Auditing of Data Integrity - Approaches and Tipps

Heidelberg, Germany

Course No 17502

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Speakers

Dr Thierry Dietrich
 

Background

The auditing and assessment of data integrity is getting more and more relevant. This includes its coverage in authority inspections, external and internal audits, self-assessments and other type of assessments. Auditing and assessing data integrity is of paramount importance within the quality risk management of any life sciences company’s quality System.

There are many reasons for the growing relevance of data integrity, even though it is no new requirement. Some of them are:
  • the increasing usage of electronic records and signatures across the pharmaceutical and medical devices industry
  • the ever growing complexity of the IT landscape
  • the implementation of new technologies (e. g., Cloud Computing, Blockchain, Track & Trace, IoT)
  • the associated growing focus on data integrity in public authority inspections in the last years
  • evolving regulatory requirements and guidance as well as standards in technology
However, economic activities such as headcount reduction, efficiency and productivity optimization, outsourcing of processes and activities, growing complexity in the supply chain, etc. lead to an increasing importance of data integrity audit programs as well, as these can have a serious impact on data integrity.

Target Group

The Webinar targets responsible individuals in quality assurance, quality control, audit departments, production and IT as well as other relevant departments being subject to inspections or audits, or auditing / assessing data integrity themselves.

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

The goal of this Webinar is to provide answers to the following questions:
  • What are typical inspection findings pertaining to data integrity?
  • What are the expectations/requirements of public authorities towards the auditing of data integrity?
  • How do I integrate data integrity into my audit planning?
  • Which measures can be taken during audit preparation?
  • Which approaches exist during audit execution to delve into this topic?
  • How do public authorities approach data integrity in their inspections?

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