COURSE ID 2765

Designing an Effective Environmental Monitoring Program

Determining a Cleanroom State of Control

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Charity Ogunsanya

Price
$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

The importance of designing an effective Environmental Monitoring (EM) program cannot be overemphasized. The data from this program provides an effective measuring tool that determines an effective cleanroom control 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 help in ruling out cleanroom contamination using the data generated.

This 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.

Upon completion of this course, you will be able to:

  • Explain regulations guiding the environmental monitoring program
  • List the four phases of the Environmental Monitoring (EM) program,
  • Describe how to choose effective and compliant Environmental Monitoring sampling plans
  • Process and relate the adequacy of an effective Environmental Monitoring excursion investigation to a continued cleanroom contamination and state of control.
  • Evaluate and write an effective Environmental Monitoring trend report
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This 90-minute ON DEMAND 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
  • Material Management
  • Engineering
  • Vendor/Suppliers
  • Regulatory Affairs
  • All Levels of Management

Course Instructor

Charity Ogunsanya

Owner/CEO, Pharmabiodevice Consulting LLC

Charity Ogunsanya’s Courses

Accreditation

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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