Event
Course Description:
This 1 day course discusses the USP Package Integrity Evaluation <1207> series of general chapters.
This course will focus on the practical aspects of various Container Closure Integrity (CCI) test technologies in the overall context of sterility assurance and provides a systematic approach to the selection and application of these leak test technologies throughout the drug product lifecycle.
Upon completion of this course, you will be able to:
- Describe <1207> recommendations on CCI.
- Define CCI requirements for various container and drug product types using a risk-based approach.
- Explain principles of various CCI testing technologies and their practical applications.
- Define CCI test method development and validation approaches and best practices.
Who should participate:
- Parenteral drug packaging engineers and formulation scientists
- Laboratory scientific staff and managers
- Parenteral manufacturing staff
- Sterility QA staff
- Regulatory affair scientists
- Pharmaceutical packaging component manufacturing staff