Molnar-Institute: Quality by Design (QbD) Course

Quality by Design: Principles for the Development of HPLC Methods

Course Overview
Who Should Attend
Course Outline
Instructors
Course Dates and Location
Registration

Course Overview (PDF)

This one-day course on Quality by Design (QbD) focuses on new approaches for achieving robust reversed-phase chromatography (RPC) methods using the so-called "Design Space," with the goal of gaining more flexibility in routine HPLC applications. Before a successful validation can take place, the limits of possible adjustments in parameter settings should be evaluated. This course is devoted to HPLC users who want to understand the meaning of QbD and to better understand the HPLC method development processes, especially with regard to the submission of new drug applications.

Who should attend

Analytical chemists and members of R&D or quality control groups in the pharmaceutical, chemical, and food industries.

Course Outline

Topics for this course include:

Which is the preferred analytical technology for final product testing and release

What are the basics of RP-HPLC

How to build quality into a product or process by focusing on gaining scientific understanding and knowledge during the development process, having the goal of reducing variation and consistently producing a quality product.

How to use a QbD approach for RP-HPLC method development

How to build robustness into the method during the development phase,

How can be the knowledge about robustness carried forward through manufacturing, eliminating the costs and delays associated with the redevelopment and revalidation of unreliable methods.

Instructors

Dr. Imre Molnár studied chemistry in Saarbrücken with special training in analytical chemistry. He then worked for two years as a postdoctoral fellow with Csaba Horváth at Yale University, USA, on fundamentals of reversed-phase chromatography. He has more than 30 years of experience in the development of HPLC instruments, column production, and HPLC applications and is specialized in pharmaceutical and biopolymer research and analysis. He has served as an HPLC instructor throughout his career. Since 1986, Dr. Molnar worked in close cooperation with Lloyd R. Snyder, John Dolan, Tom Jupille, and co-workers from LC Resources. Inc., USA, on the development of DryLab software.

Dr. Hans-Jürgen Rieger studied chemistry in Berlin. He has worked since 1999 for Molnár Institute as an application chemist with a specialization in software programming. In coorperation with Dr. Molnar, he is responsible for the development of new versions of DryLab and the software tool PeakMatch.

Dipl.-Ing. Alexander H. Schmidt, Head of Quality Control & Lab manager at Steiner Arzneimittel, offers a diverse array of experience in analytical method development and validation, QbD, analytical instrument qualification, quality control, quality assurance, GMP and maximizing productivity in the lab. He manages a R&D and contract analysis lab and supervises 25 lab assistants and chemists. Over the years, he has published numerous articles on HPLC and UPLC method development for small molecules drugs and complex natural compound mixtures. He is also a guest lecturer at the Beuth University of Applied Sciences and the Molnár Institute.

Course Dates and Location

This course takes place in Berlin, Germany on the following dates:

28 March 2012
09 Mai 2012
05 September 2012
07 November 2012

Registration

The cost of this course is EUR 795.00.

To register for courses, please:

Download and complete the Seminar Registration PDF, and fax it to us at +49 30 421559-99 - or -

Contact us directly by telephone or e-mail. Indicate the number of interested participants, and we will send you a price quote and a confirmation of the date.

For registration six weeks in advance of the course date, the cost is discounted. DryLab users may qualify for a special reduced fee. Please contact us for details.

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