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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 2: PRIOR KNOWLEDGE, KNOWLEDGE MANAGEMENT AND THE QUALITY TARGET PRODUCT PROFILE

Speaker(s)

Siegfried  Adam, PhD

Introduction to mock projects/prior knowledge

Siegfried Adam, PhD

QA Manager, Hermes Pharma, Austria

Erich  Hochuli

Introduction to mock projects/prior knowledge

Erich Hochuli

Consultant, DoE expert, ICB Consulting, Switzerland

Fritz  Erni, DRSc

Knowledge management – presentation of a simple KM concept (including practical work)

Fritz Erni, DRSc

Consultant, ICH expert, Switzerland

Fritz  Erni, DRSc

Development of a QTPP for the 2 mock projects (practical work)

Fritz Erni, DRSc

Consultant, ICH expert, Switzerland

Erich  Hochuli

Development of a QTPP for the 2 mock projects (practical work)

Erich Hochuli

Consultant, DoE expert, ICB Consulting, Switzerland

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Ways to register

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

This course has limited capacity. Register early!

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