Dr Markus Dathe
F. Hoffmann-La Roche
Referierende
Shortcuts: compact learning units of 1–3 hours – perfect for a quick overview or a focused deep dive into a specific topic. Book online, receive access within minutes and benefit from 7 days of on-demand availability, giving you maximum flexibility in your day-to-day work.
Compact. Flexible. Immediately available.
Discover GMP & GDP Shortcuts
Compact. Flexible. Immediately available.
Discover GMP & GDP Shortcuts
Zielgruppe
This Shortcut 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.
Zielsetzung
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.
Programm
This shortcut 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
Weitere Informationen
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (
www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register. Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Contacts
Questions regarding content:
Dr Christian Arndt, +49 6221 84 44-14, arndt@concept-heidelberg.de
Questions regarding Organisation:
Ms Sonja Geppert, +49 6221 84 44-95, geppert@concept-heidelberg.de
Ms Sonja Geppert, +49 6221 84 44-95, geppert@concept-heidelberg.de
Duration of the Shortcut: appr. 1,5 h
Recorded in October 2020
Recorded in October 2020
Please note:
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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