Webinar: Impurities coming from Supply Chains
Im Auftrag der ECA Academy
Seminar Nr. 18526
Important: Registration deadline is 12 noon on 11 January 2021.
All times mentioned are CET.
Unser Seminarservice
Kosten
| ECA-Member: | EUR 249,-- |
| Non ECA Member: | EUR 299,-- |
| EU/GMP Inspectorates: | EUR 299,-- |
Alle Preise zzgl. MwSt.
Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de
Sprecher
Jürgen Martin, Martin Consulting, Germany
Hintergrund
Pharmaceutical products are typically distributed within a network of global supply chains between API-, excipient- and packaging material suppliers and sites in pharmaceutical industry. It is one key part of GMP-activities to make sure impurities coming from the supply chain are managed adequately to avoid any product quality risk. Currently elemental impurities (covered by ICH Q3D Guideline) but also Nitrosamines (covered e.g. by EMA documents published in September 2019) are in the focus of the authorities. To manage these challenges risk management according to ICH Q9 guideline is a common and helpful tool to be in compliance for such topics in an efficient and ongoing way.
Zielgruppe
The webinar addresses all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered.
Technical Requirements
For our Live Online Trainings and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
In this webinar you will get to know how the risks of contamination associated with supply chains can adequately be evaluated. The following aspects will be addressed:
- Process mapping to understand impact factors to product quality
- Risk measurement and evaluation of process steps according to ICHQ9
- Vendor audits as important activity for processes knowledge and
- to monitor the quality level
- Vendor complaint tracking as important source for quality level
- evaluation
- Definition of adequate in-house testing programs for impurities
- Risk based approach for supplier quality evaluation
- Defining mitigation activities (e.g. adjusted sampling and testing approach)
- Software support for information tracking
In order to illustrate the causal relations some case studies will be provided.
The duration of the webinar is 1.5 hours.
The duration of the webinar is 1.5 hours.
GMP Seminare nach Thema
- Qualitätssicherung / Dokumentation
- Regulatory Affairs and Compliance
- Entwicklung / Prüfpräparate
- Datenintegrität
- Qualitätskontrolle / Analytik / Statistik
- GDP - Lager - Logistik
- Computervalidierung
- Validierung / Qualifizierung
- GMP in Produktion / Technik
- GMP für Wirkststoffe und Hilfsstoffe
- Medizinprodukte und Kosmetika
- GMP Basisausbildung
- Packmittel / Verpackung
- Hygiene / Mikrobiologie / Steril
- Biotechnologie
- Einkauf / Betriebswirtschaft / Effizienz
- European Conferences and Education Courses
- Sonstige Themen