Overview
Over the past two decades, industries have seen a huge number of regulatory changes. These can be found in:
- FDA Guidelines for Industry (2008), which replaced sterility testing with container closure integrity testing (CCIT)
- USP Chapter (2019), which details the processes companies should follow when carrying out packaging integrity assessments for sterile products
- EMA Annex 1 (2020), which outlines the appropriate manufacturing process for sterile medical products
With these changes in mind, companies need to start using a deterministic approach for any new pharmaceutical product or medical device they take to market.
This new deterministic approach is more sensitive, more accurate and more non-restrictive, and helps ensure more reliable results during stability studies.
Objective
Daniel Tatarsky will moderate a discussion, with our panel of experts, on how clients can easily switch from a probabilistic to a deterministic approach. The panel 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 discuss how to choose the best methods.
Agenda
- Introduction
- Compare probabilistic and deterministic approaches
- Review the different methods 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
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