GMP-Lead-Auditor/in - Vertiefungsmodul: Biologische Arzneimittel
In diesem Vertiefungsmodul werden die besonderen Anforderungen und Herausforderungen bei der Herstellung biologischer Arzneimittel ausführlich behandelt. Da diese Arzneimittel aus lebenden Organismen gewonnen werden, sind spezifische Qualitätssicherungsmaßnahmen und die strikte Einhaltung von GMP-Vorgaben unerlässlich, um die Sicherheit und Wirksamkeit zu gewährleisten. Sie erfahren, wie Audits bei Herstellern biologischer Arzneimittel effektiv geplant und durchgeführt werden und erhalten Einblicke in die relevanten Prozesse und Technologien.
Inhalt des Webinars:
- Detaillierte Kenntnis der GMP-Vorgaben und regulatorischen Rahmenbedingungen für biologische Arzneimittel
- Analyse der komplexen Produktionsabläufe und der kritischen Kontrollpunkte
- Bewertung der Qualitätssicherungsstrategien und Validierungsverfahren
- Methoden zur Identifizierung von Risiken und zur Umsetzung effektiver Korrekturmaßnahmen
- Praktische Fallstudien und Übungen zur Anwendung des Gelernten in Auditszenarien
Am Ende dieses Moduls sind Sie gut gerüstet, um die spezifischen Herausforderungen im Bereich der biologischen Arzneimittel zu meistern und somit einen wertvollen Beitrag zur Sicherstellung der Qualität dieser therapeutischen Produkte zu leisten.
Dauer: ca. 90 Minuten
Vortragssprache: Deutsch (Folien z. T. Englisch)
Aufzeichnung von 07/2025
Referent: Dr. Gabriele Wanninger
Dieses Webinar ist auch als Zertfizierungsprogramm zum/zur GMP-Lead-Auditor/in buchbar.
Weitere Informationen hierzu sowie Buchungsmöglichkeiten finden Sie hier:
Zertifizierungsprogramm zum/zur GMP-Lead-Auditor/in
Hinweis zum Kontingentabruf: Bei Buchung dieses hier beschriebenen Webinars wird je Teilnehmer eine Einheit abgezogen.
Für ganze Teams und kleine Gruppen bieten wir Ihnen attraktive Rabatte an – kontaktieren Sie uns gerne per E-Mail unter info@alphatopics.de oder rufen Sie uns direkt an!
- Dr. Gabriele Wanninger
PharmaKorell GmbH
E-Learning | Streaming im MP4 Format
Prizes & Conditions of Participation
per person plus VAT. - Payment upon receipt of invoice.
The fee includes for a single booking:
- the one-time viewing of the booked webinar/ or webinar series by the person(s) named to us in advance.
- the receipt of the slides shown as a printable PDF file.
The training is personal and, if booked individually, is for personal training purposes only - not for an entire team. We thank you for your fairness.
Cancellation or change of person is not possible after sending the handout (live: usually 1-2 days before the event | recording: immediately).
Full terms and conditions and participant information can be found here.
Consent to photographs and film recordings as well as their publication: We would like to point out that photographs and film recordings are taken during our events by persons or service providers commissioned and authorised by us for the documentation of our events (legal basis Art. 6 para. 1 lit. f DSGVO). The recordings serve our public relations work as well as the use, publication and distribution in print, digital and online media, such as newsletters, websites, brochures, flyers and social networks. In this context, it is pointed out in particular that photos and videos on the internet can be accessed by any person. It cannot be ruled out that such persons will continue to use the photos/videos or pass them on to other persons. By registering for and participating in the event, you agree that the organiser is permitted to publish photos, audio and/or film contributions taken at the event without restriction, including for advertising purposes, across all media without permission or remuneration. You have the right to revoke this consent at any time. The revocation of consent does not affect the lawfulness of the processing carried out on the basis of the consent until the revocation. This means that consent can be revoked with effect for the future. We will then immediately remove your photo/video from our website. In this case, please send your revocation to info(at)alphatopivs.de, stating the event.
Special prices for team bookings:
If the training is of interest to a group of colleagues, please contact us. Here we offer special group prices for you as a company. The group size is limited to a maximum of 30 participants per webinar. You can participate live or stream the webinar at an individual later time in our video library.
You are interested in a live event but don't have time on the scheduled day of the live webinar?
Then simply ignore the reminder emails about the live event. Our webinar platform will register that you were not present. As soon as the webinar has taken place, you will automatically receive an email from us a few hours later with your personal link to stream the webinar. You can then watch the webinar - individually - whenever your schedule allows. If you have any questions about the content, you are welcome to send them later to fragen@alphatopics(dot)de.
Note on contingent retrieval:
When booking via your company contingent, please note the separate note in the description of the webinar as to how many parts will be deducted from your contingent for the selected webinar, or webinar series.
Save money by booking a quota of 10 and combine any 10 individual webinars (90 min. each) from the topics offered.
Price: 2,500.- € per contingent plus VAT.