Microbial Control in the Pharmaceutical Industry / Annex 1

Short description

Average score for this course on November 12th: 9 out of 10

This course covers the most important microbiological concepts in the pharmaceutical industry:

• Microbiology
• Annex I Contamination Control Strategy
• Cleanroom principles
• EM techniques
• Microbial testing

During this course participants will face the challenge to combat and control the constant threat of microorganisms. Microorganisms are everywhere at all times and the greatest challenge is to keep their introduction and growth under control. This demands a good understanding of microbiological sources and living conditions.
 

Objectives

1. Have a good understanding of the sources and environmental conditions of microorganisms
2. Know the purpose of the different contamination control mechanisms and the impact if they do not function properly
3. Know which activities during the manufacture of sterile and non-sterile products are critical in keeping the introduction of microorganisms under control.
4. Have a good understanding of Annex I
5. Know how to make a Contamination Control Strategy

Target group

1. Staff (analysts, operators) who execute activities in classified areas.
2. Quality officers, managers, supervisors, who would like to gain a clear and practical insight into the pharmaceutical microbiology.