Kursbeschreibung
Drug manufacturing represents cost-intensive proceeding which has to follow accurately to international guidelines and directives. International authorities such as Food and Drug Admistration (FDA) and European Medicines Agency (EMEA) are responsible for approval of therapeutic agents. Good Manufacturing Practice (GMP) compliance of manufacturers is obligatory for successful approval.
Prospective project managers dealing with GMP compliance have to face enormous documentation requirements in different areas of drug manufacturing. Their responsibilty is focussed on a setup of documentation structures for maintenance of quality and safety.
This seminar deals with current regulatory affairs in Good Manufacturing Practice directed by US agency FDA. Relevant guidelines for compliance and documentation requirements for development and production are illustrated.
Datum
auf Anfrage
Uhrzeit
Online-Seminar (jederzeit buchbar und abrufbar)
Dauer
24 Minuten
Ort
Online-Seminar
E-Mail
Kontakt
Dr. Christian Grote-Westrick
Straße
Torfkuhle 17
PLZ
48734
Ort
Reken
Land
Deutschland
Bundesland
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Zielgruppe
Life Science Doktoranden und Postdocs mit Fokus auf Einstieg in die Pharma-Industrie Arbeitssuchende Akademiker mit Fokus auf Pharmaindustrie
Zertifikat(e)
Nach Beendigung des Online-Seminars wird ein Teilnahme-Zertifikat mit allen Inhalten (Richtlinien, Gesetzesstellen, GMP-Keywords) per Email an den Teilnehmer versendet.
Kosten
€ 19,99
Kursnummer
BSoD-02
