Steritest™ School and Advanced Operator Training

 
 

Understanding Good Practice in Sterility Testing

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Full-Day Course

According to the United States Pharmacopeia (USP)’s guidelines, “training curricula should be established for each laboratory staff member… They should not independently conduct a microbial test until they are qualified to run the test.”

The pharmaceutical inspection authority, PIC/S, recommends that “sterility testing should only be performed by personnel who have been trained, qualified and certified to perform the various tasks and procedures related to sterility testing.” In addition, PIC/S states that, “personnel should undergo periodic recertification.”

Overview

This course provides an in-depth review of the regulatory requirements of sterility testing, its validation and practical implementation. The course is based on the most recent editions of international pharmacopoeias and provides information about the harmonization and differences between the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP).

As an essential part of the course, you will participate in an interactive workshop on how to perform a sterility test. Participants’ case studies will also be discussed. Our experienced instructors also provide valuable suggestions for regulatory compliance.

 


Dr. Marcel Goverde, Managing Director, MGP Consulting, Switzerland

“The possibility to share experiences and pain points during the Steritest™ School has been very useful to optimize our current procedures. In particular, the advices given by the trainer have greatly improved the sterility testing method for our reconstituted powdered products. The interaction between Merck and Fisiopharma represents a mutual partnership, we see Merck not only as a supplier, but also as a technical reference at the highest level.”
Brunilde Magliano, Fisiopharma SRL, Italy


Interactive Workshop

The interactive workshop is a core part of the course, aiding the understanding of the lecture contents with practical applications. All critical handling steps in the sterility testing procedure and its consequences for test results are discussed and solutions are explained and demonstrated.

Steritest™ Advanced Opearator Training (AOT)

With this full day course you will have the opportunity to gain experience in sterility testing, practicing with the Steritest™ pumps, media and filtration units. Please ask in advance in case you want to try a specific unit. The training will cover the theoretical aspects and interactive workshop as in the Steritest 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.

Training Program

Training Program

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

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Register for Steritest™ School

Which of your challenges does this course address?
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  • Handling issues
  • False positive test results
  • Validating products with inhibitory activities
  • False negative test results
  • Optimizing sterility testing procedures
What will the interactive workshop cover?
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  • Use of Steritest™ hardware
  • Use of Steritest™ units
  • Demonstration of general and specific sterility testing applications
  • 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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  • Understand the current requirements of pharmacopoeias and be familiar with good sterility testing procedures from method development / validation to routine test result interpretation
  • Take preventive actions to avoid false positive or false negative test results
  • Develop and optimize sterility testing 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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This course is dedicated to users of the Steritest™ system only. The course is designed for sterility testing operators, quality control, quality assurance or regulatory affairs personnel who have responsibility for the performance of the sterility test.

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