GMP COMPLIANCE FOR VOLTAREN®

TitelZeitOrtDozent
GMP COMPLIANCE FOR VOLTAREN®17.09.2024 09:00 - 17:00 (Di)OnlineDr. Christian Grote-Westrick
Keywords: 
Real-term GMP application, Making a drug ready for inspection, daily business of GMP managers
Beschreibung Kursinhalt: 

This workshop is very close at daily business. A representative pharmaceutical product (Voltaren) is used to create a GMP environment. Here all relevant jobs for life scientists in industry are addressed and contribute to a GMP compliant product in the end.
INTERACTIVE PART: In the beginning of the workshop teams will be formed (1-3 participants per team). 9 groups will start working separately under supervision of trainer. Each group will elaborate individual approaches to fulfill GMP requirements regarding their chapter of EU GMP guideline.
In the end all teams will reunite in order to be challenged by internal auditors (Team 9).

Lernziele: 

GMP requirements for production and testing of pharmaceutical products
Application of EU GMP guideline in detail
Insight into comprehensive realization of Pharma Requirements

Lehrmethoden: 

Information delivery combined with case studies and interactive participation.
This workshop is completely interactive. Several teams are working simultaneously on GMP compliance for a pharmaceutical product.

Der Kurs ist für Promovierende in folgender Phase geeignet: 

☒ Beginn der Promotion / Beginning of the doctorate
☒ Während der Promotion / During the doctorate
☒ Endphase der Promotion / End of the doctorate

Teilnahmevoraussetzungen: 

None

Technische Voraussetzungen: 

Just Zoom
(participants receive access data before the workshop)

Kursvorbereitung: 

None

Sonstige Informationen: 

facebook.com/people/Gmp-Workshops/100068981086090
twitter.com/pharmaMGT
www.grote-westrick.com

Kategorie: 
Fachspezifische Veranstaltung
Veranstalter: 
Graduate Center of Life Sciences
Verantwortung für Veranstaltung: 
Hauptverantwortung
Durchführung/Format: 
Digital/Online
Sprache: 
EN
Maximale Teilnehmer*innenzahl: 
25
Minimale Teilnehmer*innenzahl: 
5
Umfang in Stunden: 
6
Trainer*in: 
Dr. Christian Grote-Westrick

Dr. Grote-Westrick studied biochemistry at Ruhr-University in Bochum followed by diploma thesis at Harvard Medical School, Boston, USA. After PhD Thesis at RUB and Yale School of Medicine Dr. Grote-Westrick started industry business at different biotech companies in various positions.

2000-2004 Biochemistry Studies (RUB, Harvard)
2004-2007 PhD in Biochemistry (RUB, Yale)
2007-2010 R&D Manager in Biotech Company imusyn
2010-2013 Production Manager in Biotech Company BDL
since 2013 Head of QA at B.Braun
Pharmaceutical QA Head, RP GDP, GMP Trainer
Freelancing GMP Trainer at international graduate schools
Member of Directors Board at European GDP Association