Perform Sterility Testing
This course provides an in-depth review of the regulatory requirements of sterility testing, its validation and practical implementation.
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.
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
The course is designed primarily for quality control, quality assurance or regulatory affairs personnel who perform or responsible for the performance of sterility test.
- A copy of the course materials
- A Certificate of Achievement and ISO Certification upon successful completion of the course.
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.