2020 ISPE Aseptic Conference
Evolution in Aseptic Processing: Flexible and Reliable Solutions
The 2019 ISPE Aseptic Conference will focus on providing flexible and reliable solutions for the implementation and management of the latest in aseptic, barrier, containment, and aseptic best practice technologies. Now in its 29th year, this year’s program will feature regulatory and industry experts from FDA, Bayer, SKAN, F. Hoffman La Roche, Bosch, Fresenius Kabi, Evonik, Merck, Optima and many others to provide your company with the practical tools to improve your manufacturing capability and reliability. Case Studies representing innovative large and small-scale facility and process design will offer insights into successful projects designed to meet unique customer and patient needs.
Sneak Peak of What to Expect
Hear from Richard Friedman, Deputy Director, Science and Regulatory Policy, Office of Manufacturing Quality, FDA/CDER, kick-off the 2019 ISPE Aseptic Conference with the opening keynote speech.
ISPE's work was the single most important thing in the evolution from the old legacy Aseptic processing operations to isolator technology and other barrier technologies.
Richard Friedman
2020 TOPICS
- Advanced Therapy Medicinal Products (ATMPs)
- Alternate Transfer Technologies
- Aseptic Processing Science & Technology
- Cell Therapy Scale-Out Planning
- Containment Technologies for Cytotoxics
- Legacy RABS - Based Facilities
- Facility Design & Expansion Case Studies
- Formulation-Filling for Viral Vectors
- High-Speed Syringe Filling Expansion
- Robotic Applications in Aseptic Processing
- Small-Scale/Clinical Manufacturing
- Standardization of Extractables Testing
- Sterile Connectors & Materials Transfer
Who Should Attend?
• Sterile Products Processing Community of Practice
• Engineering system owners or project managers responsible for aseptic processing equipment
• Validation personnel responsible for aseptic processing equipment qualification
• Quality Assurance personnel responsible for maintaining the integrity of aseptic systems
• Quality Assurance personnel responsible for cleaning and prevention of cross contamination
• Equipment manufacturers and suppliers providing state-of-the-art aseptic technology including robotics
• Aseptic manufacturing professionals and management
• Aseptic processing consultants and regulatory specialists
• Manufacturers of design, facilities, building, commissioning, validation
• Quality Systems/Assurance and Quality Control (QA/QC) including microbiology professionals
• Compounding pharmacy and small-scale facilities professionals
• Industrial Hygienist for operational safety in aseptic processing
• Professionals new to Aseptic processing and product protection
• Plant managers
Program Committee
Board Ambassadors