Milliflex® School and Advanced Operator Training

One-Day Course

“Each person engaged in all phases of pharmaceutical manufacture should have the education, training, and experience to do his or her job… Training curricula should be established for each laboratory staff member specific for his or her job function. They should not independently conduct a microbial test until they are qualified to run the test. Training records should be current, documenting the microbiologist’s training in the proper revision to the particular SOP.” – USP

Overview

The course is based on the most recent editions of the international guidelines with special attention to the recent harmonization between the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP).

It provides an in-depth review of technical and regulatory information on bioburden testing of raw materials, water for pharmaceutical use and in process and final products. In addition it offers valuable information on new rapid methods.

Interactive Workshop

The interactive workshop is a core part of the course, aiding the understanding of the lecture contents with practical applications. All critical handling steps in the Milliflex® testing procedure and its consequences for test results are discussed and solutions are explained and demonstrated.