Environmental monitoring is one of the systems that decide about the product quality in the manufacture of sterile medicinal products. Both European and American GMP regulations place special focus on this topic.
The USP 1116, the new EU GMP Annex 1 and especially the FDA’s “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice“ deal in detail with environmental monitoring.
However, many of the requirements laid down in these documents seem to be excessive for everyday practice on the one hand and leave great scope for interpretation on the other hand.
In practice, environmental monitoring programmes sometimes develop into time-consuming, cost- and personnel-intensive measures. Therefore, it is the aim of this Training Course to provide the participants with pragmatic recommendations for the creation and implementation of environmental monitoring programmes.
Within the framework of this Live Online Training, the participants are confronted with current hot topics, like:
Alert / action levels
Relationship to batch release
Locations and frequency
Identification of isolates
Sampling procedures
and get to know solutions for their own company practice.
Target Group
This ECA Training Course is directed at staff from Production, Quality Assurance and Quality Control who is responsible for the planning and implementation of environmental monitoring programmes. It is also valuable for decision makers who have to deal with environmental monitoring data within the framework of product release.
Presentations / Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Testimonials
Seminar Programme as PDF