HUM-MOLGEN events: Designing an Effective Environmental Monitoring Program

Who Should Attend?
This 90-minute training will provide a great resource to product manufacturers with personnel in the Pharmaceutical, Biotechnology, Biologics, Drugs, Diagnostics, Cell Therapy, Medical Device, In-vitro Diagnostics industries within the following functions:

  • QA/QC
  • Microbiologist
  • Facilities
  • Chemist
  • Analysts
  • Manufacturing   • Validation
  • Materials Management
  • Engineering
  • Vendors/Suppliers
  • Regulatory Affairs
  • All levels of management

The importance of designing an effective Environmental Monitoring program cannot be overemphasized. The data from this program provides an effective measuring tool that determines an effective cleanroom controls from a Facility design, validation, implementation, disinfection, disinfectant effectiveness, gowning controls, cleanroom trafficking, aseptic controls, personnel training and practices. It also serves as a critical program that supports and guides other contamination control key evaluators and other production and testing processes that helps in ruling out cleanroom contamination using the data generated.

This 90-minute accredited training will discuss the various steps associated with the EM program from the Phases, through Validation, Implementation, Procedural Steps, Documentation Practices, Data Management, Trending of Data, EM Excursion and the relationship of the cleanroom state of control and product impact and analysis per 21 CFR Parts 211.113 “Control of Microbiological Contamination” and 21 CFR Subpart G Section 820.70.

Can't Make this LIVE Webinar?
Simply select the On Demand option when registering and we will send you the link to view the recorded version.

On Demand available approximately 3 business days after the live offering.