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Centre of Analytical Sciences (CAS)

Perform Sterility Testing

Cost: $2000/= per person for 2 days including all course materials. (Subjected to prevailing government taxes)
Venue
: Biomanufacturing Sciences & Training Center, No.1 Science Park Road, The Capricorn, #02-10/11, Singapore Science Park II, Singapore 117528
Date: 14-15 June 2017

Closing date for registration will be 1 month before the actual training date and minimum of 6 registrants to start the class.

 

 Course Description

“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 Phamacopeia 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 provides information about the harmonization and differences between the United States Pharmacopeia (USP) and the European Pharmacopeia (EP).
 

 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

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

Our experience 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 results interpretation:

  • Take preventive actions to avoid false positive or false negative test results
  • Develop and optimize sterility testing procedures
  • Understanding 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 primary for quality control, manufacturing or quality assurance personnel who perform or responsible for the performance of sterility test.
 

 Hands-On Practical Section

The practical section covers how to:

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

 Certification of this course

Merck Millipore is an Approved Training Organisation (ATO) by Singapore Workforce Development Agency (WDA) since February 2009. At the end of this course, participants will receive a Singapore Workforce Skills Qualifications (WSQ) and Merck Millipore certificate to show the course was successfully completed.

Contact Us
For registration or to find out more details, feel free to reach out to us at cas-sg@merckgroup.com or +65 8468 6934 / +65 8660 1326.