Environmental Monitoring School and Advanced Operator Training

 
 

Understanding Good Practice in Environmental Monitoring

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Full-Day Course

In the pharmaceutical industry (significantly in aseptic or parenteral production) Environmental monitoring (EM) plays an important role to ensure the safety during the manufacturing of health care products. The implementation of a detailed and reliable EM program will reduce the number of corrective actions and related investigation and report time. In the worst case an EM contamination could lead to the loss of an entire production badge.

Only personnel who have been trained, qualified and certified on the different aspects of EM (guidelines for monitoring air, surface and personnel) is able to minimize the risks and to maintain the required production quality in isolators, RABS (Restrictive Access Barrier Systems) and cleanrooms. The EM school will help you and your company to release safer products with the highest quality.

Training Program


Training Program

For more information about our course program and schedule please download our printable course description

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Overview

This course provides an in-depth review of the regulatory requirements of environmental monitoring of cleanrooms, its validation and practical implementation. The course is based on the most recent editions of GMP and USP guidelines and provides information about cleanroom classification and monitoring according to the ISO standards. You will participate in an interactive workshop on how to implement an environmental monitoring program. Our experienced instructors also provide valuable suggestions for taking the most adequate environmental sample. The course provides an in-depth review of technical and regulatory information on monitoring the air, surface and personnel in cleanrooms, isolators and RABS used in the pharmaceutical industry.

Interactive Workshop

The interactive workshop is a core part of the course, helping to understand the lecture content with practical applications. All critical handling steps in the microbial monitoring procedure and its consequences for test results are discussed and solutions are explained and demonstrated.

NEW Advanced Operator Training (AOT)

With this full day course you will have the opportunity to gain experience in Environmental Monitoring of Cleanrooms and Isolators with Merck air samplers (mobile or with remote sampling heads, Compress Gaz sampler), sampling Data Management software and culture media. The training will cover the theoretical aspects and interactive workshop as in the Environmental Monitoring School. In addition each attendee will go through an hands on session and final examination.

Duration: one day minimum. Can be on a centralized location (Molsheim only) or at customer site. In case it is on user site: the Hands On session applies to the air sampler used on the site.

Which of your environmental monitoring challenges does this course address?
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    Secure program implementation (microbial)
  • Sampling method: best practices
  • Optimsing EM procedures
  • Data analysis and interpretation
  • Compliance to the most relevant guidelines and significant increase of regulatory requirements in progress
  • Latest trends assessment in order to minimize both false negative and cross contamination
What will be covered in the interactive workshop?
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    Demonstration of best procedures for using Merck microbial air samplers (as MAS 100 NT, MAS 100 ISO Multi Heads, MAS Compress Gaz) and agar plates media (ICR ready to use culture media for isolators and cleanrooms) for surface, personnel and passive sampling
  • A case study for implementing an environmental monitoring program in a cleanroom (air, surface and personnel microbial monitoring)
  • Answers to specific user-related questions
  • Hands-on with exam (Advanced Operator Training only)
What will you be able to do after attending this course?
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    You will understand the current requirements from GMP and other international guidelines and be familiar with the good environmental monitoring procedures using microbial samplers and culture media from method development/validation to routine test result interpretation
  • Take preventive actions to avoid false positive or false negative test results
  • Develop and optimize environmental monitoring procedures
  • Understand and identify root causes for common handling issues
What will you receive?
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    A full set of course notes
  • A certificate of attendance
  • An examination form (Advanced Operator training only)
Who should attend?
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The course is designed for operators, supervisors and managers of the environmental monitoring department, QC laboratories involved in environmental sampling and/or test readings and it is also of interest for personnel from QA, regulatory affairs, production and validation departments. Personnel responsible for the performance of the environmental monitoring in pharmaceutical manufacturing.

Which topics will be discussed?
See Answer Here
    Environmental monitoring practices
  • General microbial sampling practices of air with Merck samplers, surface and personnel testing
  • Setting up your EM program, sharing a case study
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