About this Course

“Because Sterility Testing is a very exacting procedure, whereas asepsis of the procedure must be ensured for a correct interpretation of results, it is important that personnel be properly trained and qualified”- United States Pharmacopeia General Chapters <71>

This two day 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 pharmacopeias and provide information about the harmonization and differences between the United States Pharmacopeia (USP) and the European Pharmacopeia (EP).

In a hands-on interactive workshop, participants will learn how to perform a sterility test. Participants’ case studies will also be discussed. The workshop will aid the understanding of the lecture contents with practical applications. All critical handling steps in the sterility testing procedure and its consequences on test results are discussed and solutions are explained and demonstrated. Our experienced trainers will also provide valuable suggestions to help ensure regulatory compliance.

What will you be able to do after attending this course?

You will get a better understanding of the current requirements of pharmacopeias and be familiar with good sterility testing procedures from method development/ validation through 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?

• A full set of course notes
  
• Certificate of Achievement
  

Who should attend?

The course is designed primarily for quality control, quality assurance or regulatory affairs personnel who perform or responsible for the performance of sterility test

WHICH OF YOUR CHALLENGES DOES THIS COURSE ADDRESS?

• Handling issues
  
• False positive test results
  
• Validating products with inhibitory activities - false negative test results
  
• Optimizing sterility testing procedures
  

HANDS-ON PRACTICAL SECTION

The practical element of this course covers how to:

• Use of Steritest™ hardware
  
• 
  Use of Steritest™ units
  
• Demonstrate general and specific sterility testing applications
  
• Troubleshoot specific user-related situations
  

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