Container Closure Integrity: Methods & Application (Live Webcast)

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