Best practices for designing and implementing an environmental monitoring programme

Duration: 60 Minutes
The purpose of microbiological environmental monitoring is to assess the cleanliness of pharmaceutical (sterile and non-sterile) and medical device manufacturing environments. Environmental monitoring involves the collection of data relating to the numbers or incidents of microorganisms present on surfaces, in the air and from people. In addition, non-viable particle counting, is undertaken in conjunction with viable monitoring because of the relationship between high numbers of airborne particles and microorganisms. Monitoring is not the same as control, although the two are connected. This webinar looks at the key factors required for building and developing a successful environmental monitoring control program.
Environmental Monitoring Programme
Instructor: Tim Sandle
Product ID: 504499
Objectives of the Presentation
  • How to assess environmental monitoring against regulatory expectations
  • How to devise an environmental monitoring program
  • Benchmarking environmental monitoring
  • Revising and adapting environmental monitoring
  • Fitting environmental monitoring into the overall contamination control strategy
  • Understanding sources of contamination and the appropriate methods
  • Understanding method limitations e.g. instrumentation, culture media and viable but non-culturable organisms
  • How to trend data
  • How to set alert and action levels
  • How to investigate contamination
  • How integrate rapid microbiological methods
Why Should you Attend
Environmental monitoring needs to be broad, holistic, well thought out and supported by a detailed rationale to cover areas like when to monitor, how to monitor, how frequently to monitor, how to assess data, and what to do when excursions occurs. This webinar draws these disparate elements together and guides you to putting together a strong and compliant program.

Areas Covered
  • What environmental is and what it is not
  • The objectives of environmental monitoring
  • Contamination sources and risks
  • Aspects to consider with EM methods
  • Rapid microbiological methods
  • Core elements of the EM program - what, when and how often?
  • Data and CAPA
  • Profiling microbial contamination
Who will Benefit
  • Microbiologists
  • Microbiology managers
  • Quality Control
  • Quality Assurance
  • Compliance
Topic Background
The aim of this webinar is to outline the important components of an environmental monitoring program and in doing so provide practical advice for those tasked with setting up a program or who wish to review an established program (an activity which should be undertaken on a periodic basis). There are differing elements with each program since facilities differ in terms of products, procedures, people, design, and environments. Consequently, each microbiologist will need to develop a monitoring program appropriate to their facility, and this webinar provides guidance as to how to do this.
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Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
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