Tuesday, January 9, 2018
11:30 – 1:00 pm EST
Instructor: Marsha Steed (Hardiman)
Non-viable air and viable air and surface monitoring of controlled environments is not a new concept and has been a regulatory requirement for many years. In the past, many companies selected Environmental Monitoring (EM) sample locations based on a grid approach of dividing up the rooms and taking samples inside all of the grids. Current regulatory requirements involve taking risk based approaches in the manufacturing of products, including Environmental Monitoring. Does your current EM Program consist of many floor and wall sample locations? Do you ever ask yourself if the data you are collecting every week/month/year in your EM Program is value added?
Current regulatory expectations are that your EM Program is based on risk of microbial contamination in your process. Formal risk assessments should be performed to justify your EM sample site locations and frequencies. In doing so, your EM Program will ensure that the data you are collecting is meaningful and can help to identify potential contamination problems in your products and processes. This presentation will discuss how to establish a risk-based Environmental Monitoring Program. During this session we will discuss how to set up a new Environmental Monitoring Program based on risk as well as how to perform a reassessment of your current Environmental Monitoring Program to re-establish sampling locations and frequencies based on results of your risk assessments coupled with the knowledge gained from your current EM Program historical data. The presentation will discuss how to perform an environmental monitoring risk assessment including a review of tools that can be used. It will also discuss the regulatory requirements for Environmental Monitoring around the globe. The presentation will review some of the fundamentals of Environmental Monitoring including the differences in room classifications and how this impacts the sample selection/frequencies chosen in your EM Program. Different types of sampling media and equipment will be reviewed as well as incubation of media, data collection, microbial identifications and data trending. We will allow some time for Q&A at the conclusion of the presentation.
By attending, you will learn:
- Current regulatory requirements for environmental monitoring
- How to select sample locations based on risk
- How to perform a risk assessment to support your EM Program
- Differences in room classifications and impact to your EM Program
- Monitoring methods, equipment and media types
- Data collection, microbial identifications and data trending options
$385 for one person
$700 2-5 people
$999 6-10 people