Understanding Design of Experiments (DoE) in the Pharmaceutical Industry
12/13 October 2021, Heidelberg, Germany
Course No. 18390
Speakers
Dr. Raphael Bar
BR Consulting
Objectives
This course will explain the basics of DoE with practicing with factorial and fractional DoE as well as DoE by RSM If you have no or little previous knowledge with DoE, you will learn how to set up an experimental design and how to explore the effect of factors that influence either a development/production process or an analytical procedure while taking into account interactions between the factors.
To better understand and assimilate the DoE principles, you will learn first to calculate the main effects and factors interactions by simple manual calculations (with Excel). Then, you will learn how to use Minitab software program to create a variety of DoE designs, analyze and interpret them. Multiple exercises and examples from pharmaceutical development and laboratory analysis such as robustness studies will be solved by the participants. The participants will learn how to interpret the output of a DoE programme.
Background
With FDA´s Process Validation Guidance for Industry from 2011 and the Annex 15 Revision 2015 process validation has changed to a life cycle. And the life cycle starts with the development which delivers process knowledge and the critical process parameters. To get there the FDA mentions „Design of Experiments“ (DoE). Therefore, DoE is a tool for implementing the process validation life cycle.
Also, ICH Guidelines Q8 (Pharmaceutical Development) and ICH Q9 (Quality Risk Management) speak about DoE as a tool, also in relation to Quality by Design (QbD= approaches).
Meanwhile, DoE is also common practice in other pharmaceutical areas, i.e. in the analytical development or as a CAPA measure for process optimisation.
Target Group
The addressees of the event are employees from the development, quality control lab and quality assurance departments who are using DoE or wanted to use DoE in the future. We address also GMP auditors and inspectors and validation personnel also involved in DoE.
Minitab
Each participant should bring a laptop with Excel and a previously downloaded 30 day free-trial Minitab 19 program from http://www.minitab.com. This program should be downloaded on a laptop a few days before the beginning date of the course and verified that it works on the laptop.
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Testimonials
Seminar Programme as PDF