Quality by Design - Making Next Generation Process Efficiency a Reality for 2015

Making next generation process efficiency a reality for Chemical and Biotech Product Development and Optimisation.

Quality by Design (QbD) concepts are becoming the 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?

As part of our Chemical Manufacturing series, DIA brings together expert faculty from Regulatory agencies, academia and industry. ICH and DoE expertise will accompany you to building a practical knowledge base.

METHODOLOGY & OUTCOMES:
By the end of this 2.5-day course, you will have enough knowledge and reference points to establish a Design Space and essential elements of the Control Strategy. Through a series of case studies you will learn how to use Quality Risk Management (QRM), Process Characterisation, Design of Experiments (DoE), Development of a Design Space and Control Strategy, as well as the tools of Knowledge Management (KM).

You will learn how to prioritise the potential critical formulation and process parameters with QRM, propose, execute and evaluate a DoE to define the critical parameters and eliminate non-critical parameters.

The course will also provide an overview on global requirements including new relevant EU regulations and discuss opportunities for an optimal QbD submission.

Event Time: 12:30 am to 5:00 pm.

Event Category: Classes / Courses | Professional Training.

Artists / Speakers: Christa Wirthumer-Hoche, Johannes Khinast, Siegfried Adam.

URLs:
Website: http://atnd.it/27342-0
Booking: http://atnd.it/27342-1

Prices:
Member Charitable Nonprofit/Academia: EUR 775,
Member Government: EUR 775,
Member Standard: EUR 1550,
Non-Member Charitable Nonprofit/Academia: EUR 935,
NonMember Government: EUR 935,
NonMember Standard: EUR 1710.