Kursbeschreibung
Regulatory Affairs for Medical Products
Every company has to face increasing demands of regulatory authorities. In case of diagnostic and therapeutic products in particular risk potential has to be considered.
Here European and US agencies published directives to classify own medical products which also directs towards specific approval procedures.
Prospective project managers dealing with Regulatory Affairs have to realize: compliance in documented quality and safety regulations decides about successfull approval in corresponding country.
This seminar delivers insider information on setting up quality management systems compliant to ISO 9001 with several templates for own establishment. Furthermore classification of medical products due to international guidelines and following approval process is illustrated.
Datum
auf Anfrage
Uhrzeit
Online-Seminare (jederzeit abrufbar)
Dauer
32 Minuten
Ort
Online-Seminar
E-Mail
Kontakt
Dr. Christian Grote-Westrick
Zielgruppe
Life Science Doktoranden und Postdocs mit Fokus auf Einstieg in die Pharma-Industrie Arbeitssuchende Akademiker mit Fokus auf Pharmaindustrie
Zertifikat(e)
ach 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-01
