Validation of Microbiological Methods

Detalji

Ažurirano Četvrtak, 05 Lipanj 2008 14:08

Seminar Scheme World by Measure

Speaker:
Mr. sc. Marija Starčević

About the Seminar

Introduction

The purpose of the seminar Validation of microbiological methods is to train participants in the processes for independent realization of validation of microbiological methods. Theoretical and practical aspects of parameters, processes and documentation of validation of microbiological methods (determination of the total viable aerobic count and specified micro-organisms by the plate count method and by the membrane filtration method), new microbiological testing methods, culture media, reference micro-organism and biological indicators will be discussed.

Objectives

• To make participant aware of the ground thesis - validation of microbiological method is a basis of quality microbiological analysis; invalidated microbiological procedures are worthless.
• Dismiss views that only top-class microbiological laboratories validate their methods.
• Show that the principles of good practice are prerequisite to validation of microbiological methods.
• Familiarize participants with the strategy of validation of microbiological methods.
• Set a frame in which validation has to be done with certain rate of flexibility given to the analytical personnel.
• Give recommendations about the type and content of documentation that are preamble to validation.
• Give practical examples to show the main principles of validation of various microbiological methods.

Intended audience

• Managers of microbiological laboratories in assurance and quality control
• Managers of microbiological laboratories in test laboratories
• Personnel in microbiological laboratories
• Everyone interested in this topic

Agenda

Lecturer

MSc Marija Starčević earned a Masters Degree at the Faculty of Technology in Zagreb; study programme of Engineering chemistry, programme of Ecological engineering. For three years, she worked as an assistant at the Faculty of Technology specializing in problems of biological degradation of liquid waste. After three years she established a microbiological laboratory in Neva and introduced a method of microbiological control of cosmetic products, compounds and production requirements and conditions. For the past 26 years Marija Starčević has been working in Pliva, first as a microbiologist - analyst, and for the last 13 years as a manager of a Department for microbiological analysis. She worked on matters of control and assurance of microbiological quality of pharmaceutical and cosmetic products, conditions in microbiologically clean and sterile productions, introduced Good validation practice and validation of microbiological methods. She also played an active part (from concept through realization) on the project of a new microbiological laboratory and laboratory for sterility which is developed and works in accordance to current European and American standards and is supervised by FDA .