header-image

Data Integrity at GDP - Webinar Recording

Seminar-Nr. 18228A

Referent:innen

David Abraham

David Abraham

QRS-Associates

Hintergrund

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.

Zielgruppe

The webinar 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.

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

Programm

This webinar 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
Recording from 21.09.2020
Duration of recording: about 1.5 h.

ECA-Member*: € 249,-
Regular Fee*: € 299,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

icon
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
icon
Weitere Termine online
Weitere Termine online nicht verfügbar

Haben Sie noch Fragen?

Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de

Frau mit Headset

Zurück

Teilnehmerstimmen - das sagen andere über unsere Seminare:

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

NEWSLETTER

Bleiben Sie informiert mit dem GMP Newsletter von Concept Heidelberg!

GMP Newsletter

Concept Heidelberg bietet verschieden GMP Newsletter die Sie auf Ihren Bedarf hin zusammenstellen können.

Hier können Sie sich kostenfrei registrieren.

Kontakt

Kontaktieren Sie uns

Haben Sie Fragen?

Concept Heidelberg GmbH
Rischerstraße 8
69123 Heidelberg

Tel. :+49622184440
Fax : +49 6221 84 44 84
E-Mail: info@concept-heidelberg.de

zum Kontaktformular