Environmental Monitoring:
A Contamination Control Tool


November 2nd, 2021 11:00 PM – 12:00 AM EDT

November 3rd, 2021 11:00 AM – 12:00 PM SST

The draft revision to EudraLex Annex 1 emphasizes the importance of a well-defined contamination control strategy. Environmental monitoring (EM) is an essential component of a site’s contamination control toolkit. In this webinar, we will discuss what EM does (and doesn’t do), and how to develop or refine an EM program to achieve a well-rounded contamination control strategy. This webinar is ideal for quality assurance, quality control, and manufacturing personnel seeking to understand how EM fits into a contamination control strategy, to learn how to data-mine from an EM program, and to identify improvement opportunities.

Top Five Benefits

  1. Learn the purpose of EM, and the role EM does and does not play in the contamination control
  2. Understand the impact of room cleaning on contamination control
  3. Understand the importance of personnel in a controlled environment, from aseptic behavior to gowning to interventions
  4. Identify potential red flag practices with the aid of real-world examples
  5. Learn how to use your EM program to identify and control sources of contamination

SPEAKERS


Elizabeth Brockson

Associate Director, Global Quality Control, CAI


Elizabeth Brockson has a background in benchtop microbiology and immunology, as well as over 7 years of experience in FDA-regulated businesses as a quality assurance and quality control technical professional. She is currently a consultant with Commissioning Agents, Inc. Her roles have included microbiology, auditing, and compliance/regulatory as they pertain to global regulations including FDA, MHRA, and Health Canada.