Webinar: Data Integrity in the Light of ICH Q7

Thursday, 15 October 2020 14.00 - 15.30 h

Course No. 18078



Dr. Markus Dathe

Dr. Markus Dathe

F. Hoffmann-La Roche

Important: Deadline is 12 noon on 14 October 2020


Data Integrity has become the major regulatory concern with Regulatory Agencies who have issued several guidance documents which focus on computerized systems, data governance and data. Even though drug products are often in the focus of Data Integrity audits and inspections, Data Integrity compliance is likewise required for Active Pharmaceutical Ingredients (APIs). The ICH Q7 guideline provides information especially for the GMP-compliant manufacturing, documentation and handling of Active Pharmaceutical Ingredients (APIs) as well as Data Integrity requirements.

Target Group

This webinar is designed for all persons involved in Data Integrity processes related to the manufacture and GMP compliant documentation of APIs, especially for persons from Production, Quality Control, Quality Assurance , Technical and Regulatory Affairs departments as well as for Qualified Persons and Auditors.

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.


This webinar will give you a comprehensive overview of the Data Integrity requirements for APIs laid down in the ICH Q7 guideline. Risk-based approaches as well as interpretations will be discussed and explained.
  • Which requirements are applicable to APIs under ICH Q7?
  • Specific Requirements and Interpretations
  • Consideration for specific risks
  • The hubris of hybrid records
  • Case study: how to achieve Data Integrity on a risk-based approach

ECA-Member*: € 249,-
Non ECA Member*: € 299,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
Further dates on-site
Not available
Further dates online
Further dates online
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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