Join Mark Miller as he speaks about Vaccines for the World and shares his insights into the design and execution of a BSL2 Fill-Finish Facility at the 2021 ISPE Aseptic Conference being held March 15-17, 2021 as a virtual conference.
The ISPE Aseptic Conference has been setting the pace for the evolution of sterile manufacturing processes and technologies in the pharmaceutical industry for 30 years. The virtual conference platform will provide a unique opportunity for expanded global participation, both by speakers and attendees. In addition to addressing recurring issues in aseptic processing, this year’s regulatory updates and panel discussions will focus on Annex 1 updates, accelerated efforts for manufacturing of vaccines, supply chain disruptions, and the impact of the pandemic on sterile manufacturing operations. Industry case studies and lessons learned will include successful applications for ATMP/cell & gene therapy facilities and manufacturing, automation for improved sterility assurance and containment for increased throughput, innovative bio-decontamination approaches, aseptic filling for combination products, H2O2 applications, bioprocessing quality risk management, and next-level ADC processing. The program content will be available to all registered attendees for a full year following the event.
- COVID-19 Impact
- Aseptic Process Safety
- Modular Robotic Fill/Finish Lines
- Annex 1 Revisions for Barrier Technologies
- Why, When, and What Regulatory Agencies Expect
- Facility Considerations for Next-Gen Sterile Manufacturing
- Containment & Cross Contamination Control for Bio-Safety
- Single-Use: Why all the hype? Is it really worth it?
- H2O2: Implications for Process & Qualification
- Intersection of ATMPs & New Technologies
- Devices and Decontamination
- Apply the latest developments in sterile processing science and technology
- Implement robotic applications for ATMP and cell & gene therapy production
- Work with highly potent/toxic products for GMP and Occupational Safety
- Understand best-practice Quality Risk management approaches
Learn more and register here.