PDA Implementation of CCS & PUPSIT Workshop 2024

Controlling contamination of sterile drug products has been a major challenge for the pharmaceutical industry for years. It has been a major cause of recalls and regulatory actions not just in emerging economies but in US, EU and other first world economies alike. This is despite the wealth of knowledge of sterile drug manufacturing processes, most current technology and improved testing methods. 

Apart from CCS, there are variations in the filtration design, set-up, operation, process stream attributes, and manufacturing operational philosophies all have a significant impact on how pre-use/post-sterilization integrity test PUPSIT is incorporated into a manufacturing process. 

This workshop will try to address and equip you with the key points of how to avoid a product contamination and establish and maintain a state of control for microbial and particulate contamination. It will also show that there is not a "one size fits all" solution for PUPSIT implementations.



Key takeaways

• How to prevent contaminants from reaching the processing area 
• People are the main source of microbiological contamination in aseptic processing. You will learn how a well-designed program selection, training, capability enhancement and qualification of cleanroom personnel is crucial to CCS
• PIC/s has adopted Annex 1, technology should be designed to match the needs of the process and manufacturing requirements and address specific sources and risks of contamination
• If and when a contamination is identified, you will learn how to evaluate or investigate the source of contamination and taking the specific actions required to maintain or return the process to a state of control
• Monitoring and continuous improvement is the key to a successful CCS program
• Learn what are the several attributes related to the integrity test operation that one must consider in determining how best to design, implement and run PUPSIT for a specific application
• Knowing the importance of not 'one size fits all' PUPSIT implementations 

Who Should Attend

Auditors, Biotech Managers, Head of Plant, Head of Quality Compliance, Engineering Managers, Microbiologists, Product Managers, Production Managers, Packaging Specialists, Quality Assurance Managers, Regional Sales Managers, Regulators, Regulatory Inspectors, Quality Control Managers, Quality Operations Managers, Regulatory Specialists, Scientists, Sterile Processing Specialists, Technical Account Specialists, Technical Directors, Unit Managers