Objectionable Microorganisms in an Aseptic Environment
Thursday, January 24, 2013 from 10:00 AM to 11:00 AM (PST)
Palo Alto, CA
This webinar will explain FDA’s current stance on the topic of “Objectionable Microorganisms,” and how this topic relates to current good manufacturing practices. It will examine the enforcement data from FDA and causes of the recalls involving medical products to help you prevent trends and set up an applicable risk assessment strategy for objectionable microorganisms.
Why Should You Attend:
In recent years the number of recalls that are related to microbiological causes has been on the rise. By looking at the enforcement data from FDA, the majority of the recalls cite the presence of objectionable microorganisms as the prevalent cause.
The FDA unfortunately is not clear on defining what constitutes “objectionable microorganisms,” and often it’s left up to the organizations themselves to make that determination. This session will review FDA regulations and guidance on aseptic processing and provide definitions of “objectionable microorganisms.”
This webinar is designed to help organizations focus not so much on an almost impossible task of preventing the presence of objectionable microorganisms in their aseptic environment, but, on the task of preventing trends and setting up an applicable risk assessment strategy.
Areas Covered in the Webinar:
- Review of recall data
- FDA regulations
- FDA guidance on Aseptic Processing
- ICH guidelines
- Definitions of “objectionable microorganisms”
- Risk assessment of the presence of microorganisms in the aseptic environment and its impact on product
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.