The Southern California Discussion Group of the ASQ Biomedical Division Presents:
Risk Based Environmental Monitoring (EM): How to use risk to ensure your EM Program is value added & efficient
An Industry Roundtable Discussion
Non-viable air, 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. Once you have a risk based EM Program in place, you need to manage the data you are collecting. A great way to gain efficiencies is by using an automated system for environmental monitoring. The Novatek Environmental Monitoring data management and trending software system, Nova-EM will be presented.
- How to perform an Environmental Monitoring risk assessment unique to your manufacturing process
- Recent changes in guidance documents and regulations for EM Programs including contamination control rates, risk based sample selections and sampling frequencies
- Learn how to optimize your EM Program with use of an automated system while gaining efficiencies
Date: Tuesday, March 25, 2014 at 5:30pm to 8:30pm
Location: Abbott Medical Optics | 1700 E Saint Andrew Place | Santa Ana | CA, USA | 92705
Novatek Topic: Risk Based Environmental Monitoring and Efficiencies Gained With Use of an Automated System presented byNovatek Expert: Cheryl Zaman-Zadeh
Reserve your seat today! Register at: https://www.eventbrite.com/e/scdg-risk-based-environmental-monitoring-programs-tickets-10847933461