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.
The live version of this recording took place on January 11-12, 2021.Includes English subtitles.
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 quality assurance staff
- Regulatory affair scientists
- Pharmaceutical packaging component manufacturing staff
.Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
The accompanying USP General Chapter(s) available as resources with this course, were official as of the date indicated in the chapter PDF. Please check www.uspnf.com for relevant updates.
USP Approved Instructor
Leslie Furr
USP Staff
Associate Scientific Liaison to the Compendial Science-General Chapters Group
B.S. in Microbiology
M.S. in Pharmaceutical Sciences