Global CMC Requirements covering the Product Lifecycle - Quality data for non-EU and management of company's global CMC interfaces
Seminar
Online
Beschreibung
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Kursart
Seminar
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Methodik
Online
-
Dauer
2 Tage
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Beginn
nach Wahl
The focus of this seminar is on CMC requirements in non-EU countries. Another key topic is the question on how to continuously secure regulatory compliance along the international interfaces.
Our experts will pass on their in-depth knowledge of standards especially for the Brazilian, Chinese, Russian and Japanes markets. They will share their experience on international variation management and give you an insight into the world of GMP. During the workshop you will have the opportunity to discuss and share your compliance issues and find personal solutions.
After attending the seminar, you will have a profound understanding of your CMC duties within the international pharmaceutical environment covering both: concrete content related topics and managerial interactivities at the interfaces: Thereby improving your skills to work towards the expectations of your interfaces.
Standorte und Zeitplan
Lage
Beginn
Beginn
Hinweise zu diesem Kurs
This seminar addresses the needs of those working in the international pharmaceutical industry. It will particularly benefit those dealing with international regulatory CMC topics and interfaces, such as
- CMC managers
- Regulatory Affairs managers
- Regional Affairs managers
- Quality Compliance managers
- Quality Assurance managers
Meinungen
Erfolge dieses Bildungszentrums
Sämtlich Kurse sind auf dem neuesten Stand
Die Durchschnittsbewertung liegt über 3,7
Mehr als 50 Meinungen in den letzten 12 Monaten
Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister
Themen
- Management
- International
- Compliance
Inhalte
Global CMC Requirements covering the Product Lifecycle - Quality data for non-EU and management of company's global CMC interfaces