Evolution in Aseptic Processing: Flexible and Reliable Solutions
The 2020 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, including Automated Visual Inspections. Now in its 29th year, this year’s program will feature regulatory and industry experts from FDA, SKAN, F. Hoffman La Roche, Bosch, Fresenius Kabi, Evonik, Merck, 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 Peek 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.
The Aseptic Processing is facing the next generation of pharmaceutical products and GMP requirements. The Annex 1 draft is in the final stage and we expect the publication before the next ISPE Aseptic Conference in North Bethesda, MD. The Annex2/PICs...
The world is getting smaller due in no small part to the technological advances. Pharmaceutical Manufacturing is moving in parallel with this trend—smaller batch sizes and personalized medicines are the trend on the horizon. But some producers, small has...
How do we best design a production facility for advance therapeutic medicinal products (ATMPs)? How about high-potent products that need to be sterile? And what are the latest developments in Barrier/Isolator technology? We will try to answer all these...
Automated Visual Inspections
Advanced Therapy Medicinal Products (ATMPs)
Alternate Decontamination Technologies
Aseptic Processing Science & Technology
Cell Therapy Scale-Out Planning
Cytotoxics, Robotics, High Potent Products
Facility Design & Expansion Case Studies
Formulation-Filling for Viral Vectors
High-Speed Syringe Filling Expansion
Modernization of a Legacy CDMO
Robotic Applications in Aseptic Processing
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