Looking to clarify and simplify your CCI approval?

Container closure integrity (CCI) is a fundamental requirement of every sterile drug product.  The United States Pharmacopeial Convention (USP) released Chapter <1207> Packaging Integrity Evaluation – Sterile Products, in 2016.  This chapter provides several new concepts which reinforce a risk-based approach that is based on the fundamentals of sound science.

CCI is a very complex issue, however, the right approach can simplify it. This webinar will provide six key areas to consider in view of Chapter <1207> that enable a holistic approach to optimize sterile product package CCI.

Join West experts, Fran DeGrazio and Christopher Barnes, on March 27 for a free webinar as they discuss a comprehensive approach to optimizing CCI, including an understanding of the impact of:

    • Materials
    • Equipment
    • Process
    • Measurement
    • Environment
    • People

In addition, the speakers will delve deeper into the many CCI measurement technologies.

Featured Speakers

Fran L. DeGrazio

Vice President, Global Scientific Affairs &Technical Services
West Pharmaceutical Services

Fran DeGrazio has been in the pharmaceutical packaging industry for more than 34 years with extensive expertise in the delivery of injectable drug products, vial and syringe systems, and injectable combination products. A sought-after speaker and author, Fran is currently an active member of the PDA PMF Visible Particulate Task Force leadership team, the IPAC-RS Materials Working Group and has received the 2017 Healthcare Business Woman’s Association Luminary Award for West.

Christopher Barnes

Technology Manager, Container Closure Integrity
West Analytical Labs

Chris Barnes joined West in 2017 to develop new technology and techniques for CCI testing, and serves as a CCI analytical expert. Chris’s experience around USP <1207>, as well as his background developing and validating methods for product/packaging systems based on the guidance, has helped West Analytical Services to become the industry leader and scientific destination for CCI as it relates to primary packaging systems. He is a member of the American Association for the Advancement of Science.

Date:  Tuesday, March 27, 2018
Time:  11am ET / 8am PT
Duration:  1 Hour

Register now for this webinar