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Pharmig Academy

Sep 21, 2015 12:30 PM - Sep 23, 2015 4:30 PM

Garnisiongasse 4/4, 1090 Vienna, Austria

Quality by Design

QbD concepts are becoming defacto best practice spearheaded by the FDA and EMA. But how can you implement ICH Q8-Q11 with confidence for small molecules and biotech products?

SESSION 3: INITIAL RISK ASSESSMENT (FMEA), INTRODUCTION TO PROCESS CHARACTERISATION AND DESIGN OF EXPERIMENTS

Speaker(s)

Fritz  Erni, DRSc

Initial risk identification and prioritisation (practical work)

Fritz Erni, DRSc

Consultant, ICH expert, Switzerland

Erich  Hochuli

Initial risk identification and prioritisation (practical work)

Erich Hochuli

Consultant, DoE expert, ICB Consulting, Switzerland

Johannes  Khinast, PhD

Introduction to tools for process characterisation

Johannes Khinast, PhD

Head of Institute for Process and Particle Engineering, Graz University of Technology, Austria

Siegfried  Adam, PhD

Design of experiments

Siegfried Adam, PhD

QA Manager, Hermes Pharma, Austria

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Registration fee includes refreshment breaks, lunches and training course material.

This course has limited capacity. Register early!

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