Aseptic Processing Summit 2024 | Pharma Ed Resources Events | 23 October 2024 | La Jolla, CA, USA
Venue
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| Event Date |
Wed Oct 23 PDT - Thu Oct 24 PDT (8 months ago)
In your timezone (EDT): Wed Oct 23 3:00am - Thu Oct 24 3:00am |
| Location | La Jolla, CA, USA |
| Region | Americas |
Details
Regulators in North America and Europe are requiring stricter standards for environmental monitoring systems, facility cleaning and disinfectant qualification, aseptic cleanroom operations, filtration, sterilization, and aseptic process simulation (or media fill). This two-day summit features expert insight into the robust aseptic processing requirements facing the industry. This summit features comprehensive coverage on the implementation and management of the latest knowledge in aseptic, barrier, containment, and aseptic best practice technologies.
Featuring In-Depth Coverage On:
• 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
Speakers
2024 Speakers
Mark Hallworth
Life Sciences GMP Advisor, Particle Measuring Systems
Andre Zdunczyk
Business Development & Marketing Director, North America, Bausch+Stroebel Machine Co.
Richard Denk
Senior Consultant, SKAN AG
Merritt Postma
Executive Director, NA Sales, SKAN US
Dan Klein
Sr. Technical Services Manager, STERIS Corporation
Tony Perry
Director, Customer Support, SCHOTT Pharma USA
Laura Moody
Director of Product, Syntegon Pharma Technology
Don Singer
Sr. Microbiology Technical Consultant, Ecolab
Amanda Curtis
Microbiology Consultant, ValSource
Jim Polarine
Senior Manager, Technical Services, STERIS Corporation
Marsha Steed
Microbiology Expert Consultant, JYA/Steed MicroBio, LLC
Josh Russell
Vice President, Sales and Marketing, AST
Mike Dingle
Senior Product Specialist, Controlled Environments, TSI
Beth Massoth
Biocontainment Specialist, CURIS Decontamination System
Derek Duncan, PhD
Director Product Line, LIGHTHOUSE Instruments
Sebastian Scheler
Co-Founder & Managing Director, Innerspace
Sponsors & Partners
2024 Sponsors
SILVER SPONSOR:
• Ecolab
EVENT SPONSORS:
• Harro Hofliger
• Bioscience International
• Syntegon
• On Drugdelivery
• Drug Development