Overview

Over the past two decades, industries have seen a huge number of regulatory changes. These include: 

• The FDA Guidelines for Industry (2008), which replaced sterility testing with container closure integrity testing (CCIT)
• The USP Chapter <1207> (2019), which details the processes companies should follow when carrying out packaging integrity assessments for sterile products
• The EMA Annex 1 (2020), which outlines the appropriate manufacturing process for sterile medical products

With these changes in mind, companies need to start using the deterministic approach for any new pharmaceutical product or medical device they take to market.

This new deterministic approach is more sensitive, more accurate, and non-restrictive, and helps ensure more reliable results during stability studies.

Objective

Daniel Tatarsky, will moderate a panel discussion on how clients can easily switch from a probabilistic to a deterministic approach with our panel of experts. They will then review the different options for implementing a deterministic Container Closure Integrity Testing (CCIT) strategy based on regulatory guidelines – with a focus on vacuum, helium, and high voltage – and how to choose the best methods.

Agenda

• Introduction
• Compare the probabilistic and deterministic approaches
• Review the different methods for container closure integrity testing (CCIT) and its applications
• Q&A

Target Audience: The webinar is aimed at all quality control and quality assurance managers, as well as packaging project managers in the pharma, biopharma and medical devices industry.

Language: English

Can't make a live session? Register now and receive a complimentary recording after the live event. For further information, please contact: healthscience@sgs.com