Please note that this training course has hands-on lab activities. Please wear long pants and closed-toe shoes.
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 draft Annex 1
- Grade A air supply
Participants will also receive a free copy of PDA Technical Report No. 13: Fundamentals of an Environmental Monitoring Program.