David Abraham
QRS-Associates
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.
Zielgruppe
The shortcut is aimed at all personnel involved at all levels within the following industries: Pharmaceutical manufacturers (e.g. logistics and QA), drug wholesalers, logistics companies, external warehouses, extended service providers offering services in support of the distribution of medicinal products.
Zielsetzung
The issue surrounding data integrity has now been with us for several years since regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA), the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO) and the European Medicines Agency (EMA) started to raise concerns to the industry. The application of data integrity is integral to Good Distribution Practice (GDP) and as complexities of pharmaceutical distribution continue to present new challenges throughout the supply chain to ensure medicinal products are not compromised. As regulators intensify their focus in data integrity it is important that managers, supervisors and Responsible Persons understand how data generation and flow are vital to ensure robustness within the supply chain and integral to GDP processes and systems.
Programm
This shortcut aims to give participants a compact overview on how data integrity interacts with GDP as well as understanding expectations of current guidance. The following topics will be covered:
- Understanding data integrity
- The differences between data and data integrity
- Guidance and industry Standards
- The principles of data integrity
- Data flow in GDP
- Integrating data integrity governance on GDP
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 Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Mr Niklaus Thiel, +49 6221 84 44-43, thiel@concept-heidelberg.de
Duration of the shortcut:1.5h
Recorded in September 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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Tel.: +49 6221 8444-0
E-Mail: info@concept-heidelberg.de
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