Product Development, Quality Control, & Regulatory Compliance
- A Risk Based Approach to an Environmental Monitoring Assessment
- Annex 1—What You Need to Know
- Using Scientific Data to assess the Risk of Sterilizing Filter Flaw Masking and the Need for Pre-use, Post-Sterilization Integrity Testing
- Designing a Risk Based Cleaning and Disinfection Program
- Continuous Microbiological Environmental Monitoring for Aseptic Manufacturing
- Innovations in Aseptic Processing-Opportunities & Challenges for Implementation
- Single Use Manufacturing Systems – Practical Considerations
- Aseptic Compounding in 503b Industry: Challenges and Mitigation
- Terminal Sterilization or Bioburden Reduction Processes using Ionizing Radiation
- Isolators for Cell and Gene Therapy: Closing the Process for ATMPs
- NextGen Now-The Future of Advanced Therapy Medicinal Products (ATMP) Facilities
- New Developments in Lyophilization and Automatic Vial Loading/Unloading
- Single-Use Technologies Used for Aseptic Processing and Final Filling Applications
- Media Fills/Aseptic Process Simulation and Validation
- Clinical and Small-Scale Aseptic Manufacturing, a Modular Filling System Approach
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