Hosted by PTI, join us for this webinar series on Container Closure Integrity, providing guidance and expertise from Brandon Zurawlow of Containsure. This series will be three 60-minute webinars (including Q &A) and will cover the following topics.
CCI Regulatory Guidance: Past, Present, and Future
Tuesday, October 6, 2020 at 10:00am (EST)
This first webinar is intended for participants of all experience levels. Historic regulatory language surrounding container closure integrity testing has led to the pervasive misconception that package integrity is specifically tied to prevention of microbial ingress, in turn creating challenges for the industry. Regulatory requirements and guidance set forth by USP <1207> and EU Annex 1, along with industry action, however, have expanded this definition.
This presentation seeks to impart upon participants an understanding of the changing CCI regulatory landscape (past, present, future) over the past decade or more, including the pitfalls of historical, probabilistic methods such as microbial ingress. Through this review, participants shall also gain a fresh perspective for reconsidering CCI requirements through the lens of the 1999 Container Closure Systems FDA Guidance.
Searching for a Silver Bullet: CCI Method Selection and the Toolbox Approach
Wednesday, October 21, 2020 at 10:00am (EST)
In an attempt to adopt a modern, deterministic CCI method, companies are presented with the challenge of choosing a method for the given product-package system. Often, there is a strong desire to choose a single technology to be employed across a product’s lifecycle, or even across a product line.
This second webinar, best for those with a basic understanding of CCI, or those who have completed the first webinar, aims to provide a high level understanding of each of the deterministic technologies listed in USP <1207>, with honest, experience-based discussion around their relative uses, advantages, and disadvantages. Examples of how the product, package, or study goals can impact CCI method selection will be discussed, and a case example of an auto-injection system presented.
“How good is good enough?” Applying CCIT in the Real World: Common Questions and Challenges
Thursday, November 5, 2020 at 10:00 am (EST)
While regulatory authorities and professional organizations such as the PDA continue to develop best practices and new guidance, the act of applying these guidance documents in the real world can be a bit abstract. This third webinar seeks to build on the information presented earlier in the series by candidly discussing common questions and challenges when implementing CCIT, including overall testing strategy, appropriate use of positive controls, acceptable limit of detection, and test sample size.
This presentation does not seek to provide concrete answers, but instead equip participants with perspectives and information to make informed decisions. A portion of the webinar will be dedicated to participant review, directly addressing thematic questions arising from earlier webinars, or from pre-webinar participant questionnaires.