Stay up to date with the latest concepts on Risk-Based Environmental Monitoring with Novatek at your local 2015 PDA Chapter events:
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.
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. Once you have a risk based EM Program in place, you need to manage the large amount of data you are collecting. A great way to gain efficiencies is by using an automated system for environmental monitoring. Use of a data management software system to simplify your EM process will be presented. Common risks associated with EM will be presented along with risk mitigation via use of automation.
Marsha and Parsa will co-present on the topic of creating a risk based EM Program and efficiencies gained from use of automation to evaluate EM data.
Marsha Stabler Hardiman has over 20 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha has a Bachelor’s Degree in Biology from Western New England University in Springfield, MA. Marsha is a Senior Consultant for Concordia ValSource and in this role helps companies implement quality risk management into their quality management systems and validation programs. Marsha currently helps companies reassess their existing EM programs and re-select sample locations based on risk. Marsha currently serves on the Parenteral Drug Association (PDA) Science Advisory Board and is leading a PDA Task Force on Microbial Data Deviations.
Parsa Famili, MS is the President of Novatek International. He has extensive back ground in pharmaceutical manufacturing and played a key role in assisting many small and large organizations define their user requirements in order to fully automate their Environmental Monitoring process. He has experience in applying solutions to the Pharmaceutical, Medical Device, Biotechnology and Food Industries in the area of root cause analysis, the application of process improvement by virtue of continuous feedback loops, compliance, statistical analysis and risk based management.
Visit our events page for monthly updates on which PDA Chapter we will be speaking at next: https://ntint.com/events.shtml.