PDA Basics of an Environmental Monitoring Program Training Course

Environmental surveillance is a tool utilized to evaluate the effect of controls on the manufacturing environment. A process to assess the cleanroom and other controlled environments of a pharmaceutical facility can serve as an adjunct to the sterility assurance program for the microbial quality of drugs. The items addressed in this training course include definitions, standards, surveillance support systems, system surveillance, validation systems, definitions and typical frequencies and levels.

During this training course, you will have the opportunity to work hands-on with environmental monitoring (EM) equipment and media and develop a surface and air EM program for PDA's cleanroom. You will utilize the information presented in the lectures to determine appropriate sampling sites and methods based on area classification, activities performed and surface type.

Additional topics that will be discussed:

• Risk assessments to support EM program
• Rapid micro method implementation for EM applications
• EMPQ creation and execution
• Routine room re-certification as per EU GMP Annex 1
• Grade A air supply

Upon completion of this training course, the attendee will be able to:

1. Apply current regulatory guidance to your environmental monitoring program
2. Implement improved environmental monitoring procedures
3. Compare and contrast new and existing environmental monitoring equipment
4. Outline how to best utilize current environmental monitoring definitions
5. Define key environmental monitoring concepts

For more options and/or related training courses, please visit the following page(s):

• PDA Environmental Monitoring Training Courses