Environmental Control and Monitoring for Regulatory Compliance

Bethesda, MD
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

Environmental monitoring and control continues to be a regulatory focus with numerous 483s having been issued to firms facing difficulties managing this critical quality systems component. By understanding both the regulatory and quality issues in environmental monitoring, companies can be assured in the quality of their finished products.

This comprehensive class will discuss facility design and validation, including personnel flow, equipment flow, baseline monitoring, media fills and quality control. The tracking and trending of the data will be reviewed, and a focus will be on the “best industry practices” to employ when performing environmental monitoring. FDA and international standards related to microbiological issues will be covered, with an emphasis on how to avoid quality problems. Finally, a case study will be presented to demonstrate the most effective and efficient methods to use when performing environmental investigations.

Who Should Attend

This course will be beneficial for environmental monitoring technicians, engineers involved in aseptic design and validation, and personnel in QA/QC, sterility testing, manufacturing, aseptic operations, validation and training.

More information coming soon.

Day 1

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

  • Summarize global regulatory requirements for environmental monitoring (EM)
  • Recognize the various EM guidance documents
  • Explain the various approaches to tracking and trending EM data
  • Evaluate automation systems used for EM
  • Discuss key validation issues with EM
  • List the benefits and use of risk analysis for EM
Agenda is subject to change.

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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD , United States

Frank S. Kohn, PhD, President, FSK Associates