1. Dr. Faezeh Eskandari
has completed a two day ECA-Course on 21 to 22 November 2013 in
Budapest, Hungary covering the following subject
ECA - ICH Q10 Training Course
Contents of the course:
Introduction to ICH Q10
Continual Improvement with a focus on CAPA,
Change Management and Annual Reviews
Continual Improvement with a focus on Process Monitoring,
KPIs, Trending, Process Performance and Capability
Responsibility of Senior Management
Monitoring Quality Process Performance and Quality System –
the Senior Management’s responsibility and
how to perform Quality Management
Management of Outsourced Activities and Purchased Material –
How to choose, qualify and monitor Suppliers and Providers
Workshops:
How to Involve Management in a Quality System
that Meets EU and FDA Inspections
How to Establish a CAPA System in a Company
Understanding the process orientation principles
from ICH Q10 reflected in FDA´s new Process Validation Guidance
Heidelberg, 22 November 2013