The PDA Container Closure Integrity Testing Training Course utilizes lectures, instrument demonstrations, hands-on testing exercises, case studies, and interactive group discussions to provide insight into the fast-evolving regulatory landscape in the container closure integrity field and the latest development in testing technologies. The Course introduces a practical and meaningful methodology to construct package integrity profiles using a risk-based approach and appropriate Container Closure Integrity (CCI) testing methods.
Key topics include:
- Up-to-date regulatory and pharmacopeia requirements on CCI
- CCI requirements for various container and drug product types using a risk-based approach
- Principles of various CCI testing techniques and their practical applications
- Testing method selection for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles
- CCI testing method development, validation approach and best practices
- Common issues and pitfalls in CCI testing applications
The Course provides on-site instrument demonstrations and hand-on testing experience of various advanced CCI testing techniques, including vacuum decay, electrical conductivity and capacitance, laser-based gas headspace analysis, and mass extraction leak test. In addition, participants can take advantage of the breakout sessions to discuss topics of interest with testing experts from major instrument vendors, such as PTI, ATC, and Lighthouse.
Who Should Attend
Parenteral drug packaging engineers and formulation scientists; Laboratory scientific staff and managers; Parenteral manufacturing Staff; Sterility Quality Assurance; Regulatory affair scientists; CMC Project Management; Pharmaceutical packaging component manufacturing staff