PDA Container Closure Integrity Testing - Basic Training Course

This training course focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to applying these testing methods for CCI verification throughout drug product lifecycle. The training course will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendia requirements. In this training course, participants gain critical problem solving skills through:

• interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
• hands-on testing training on the newest innovations and state-of-the-art instruments
• real-world case studies.

Who Should Attend

• Parenteral drug packaging engineers and formulation scientists
• Laboratory scientific staff and managers
• Parenteral manufacturing staff
• Sterility Quality Assurance
• Regulatory affair scientists
• Pharmaceutical packaging component manufacturing staff

Learning Objectives

This training course utilizes lectures, case studies, and interactive hands-on training on testing instruments to provide insight into the latest developments of Container Closure Integrity (CCI) Testing, with focus on achieving the following key objectives:

• Understanding up-to-date regulatory and pharmacopeia requirements on CCI.
• Defining CCI requirements for various container and drug product types using a risk-based approach.
• Explaining working principles of various CCI testing techniques and their practical applications, with focus on deterministic methods such as tracer gas detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laser-based gas headspace analysis, mass extraction leak test.
• Selecting and applying appropriate testing methods for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles.
• Defining CCI testing method development and validation approach and best practices.
• Avoiding common issues and pitfalls in CCI testing applications