A Quality Systems Approach to Environmental Monitoring (QMS EM)

Venue: Online

Location: Web Based, United States

Event Date/Time: Jan 27, 2009 End Date/Time: Jan 27, 2009
Registration Date: Jan 26, 2009
Early Registration Date: Jan 01, 2009
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Environmental monitoring continues to be a regulatory focus. Recent 483s have been issued to firms having difficulties in this critical quality systems function. Meeting both regulatory and quality issues in environmental monitoring can assure companies of the quality of their finished products.

This live and interactive web seminar will discuss facility validation, including facility design, personnel flow, equipment flow, baseline monitoring and quality control. Tracking and trending of data points will be discussed. FDA warning letters related to microbiological issues, as well as what the FDA and other boards of Health are looking for will also be reviewed, including an emphasis on how to avoid warning letters and 483 items related to EM issue. In addition, a case study will be provided to demonstrate how investigations should be performed.

Discussion Points will include:

Learn about global regulation requirements for EM
Review the various guidelines on EM
Understand how to track and trend data
Learn what are the key validation issues with EM programs
Provide information on quality systems and risk analysis


Additional Information

Who Can Benefit: Quality Control Quality Assurance EM Technicians Engineering Manufacturing Supervisors Training Managers