Strategies and Solutions to Protect Quality/Safety of Products and Ensure the Highest Contamination Control Standards
A large percentage of drug product recalls involve sterile drug products. The majority of sterile product recalls are due to lack of sterility assurance. The manufacturing of sterile drug products remains challenging and industry is always seeking ways to improve.
IVT’s Advances in Aseptic Processing conference demystifies the technical and regulatory framework of aseptic processing operations in a pharmaceutical manufacturing environment. Participants will walk away knowing how to implement best practices for aseptic processing, interpret FDA enforcement trends and appraise new technologies for aseptic processing.
- Assess the emerging hybrid approach-aseptic processing and terminal sterilization
- Learn what the regulators are saying
- Experiment with innovative technologies
- Understand aseptic processing for combination products
- Prepare your facility for an FDA inspection
- Implement risk management for sterility assurance
- Design a cleaning validation process for aseptic manufacturing equipment