02.13.26 -- Strengthening Your Regulatory Path: Strategies For Compliance And Safety

The 2026 ISPE Aseptic Conference, taking place 23-23 March, in Washington D.C., USA, will explore the latest developments and insights into aseptic processing, including robotics and automation, the implications of recent Annex 1 revisions, and computerized system compliance. Technical tracks include Airflow Testing, Annex 1 Case Studies, ATMPs with Multiproduct Facilities, and Sterile Processing.

Discover how digital transformation drives efficiency, agility, and compliance in pharmaceutical manufacturing to optimize processes, improve quality, and accelerate time-to-market.

Simplify impurity control by combining nucleic acid removal with residual nuclease detection. This integrated approach enhances workflow consistency and helps maintain compliance standards.

Gain centralized control of your lab. This cloud platform offers real-time monitoring and a new health check function to evaluate performance and provide corrective actions.

Patient safety is critical for regulatory success. With specialty in off-target analysis services, ensure editing confirmation, reduce regulatory risk, and improve safety profiles. 

Transition to greener biomanufacturing with high-performance, sustainable detergent. Explore a portfolio of best-in-class detergent alternatives for use in biomanufacturing applications.

Navigate documentation hurdles with ease. This video covers the essential tools and support services available to streamline your regulatory submission process and ensure submission readiness.

Review the data collection system, software, and controls that should be considered with each institution's policies and procedures to achieve compliance with 21 CFR Part 11.

This award-winning platform offers a closed, automated solution for flexible bag filling. Designed for class C or D cleanrooms, it brings efficiency and sterility to cell and gene therapy flows.