AGENDA
Aseptic Processing
Development, Implementation, and Validation
November 15, 2022
10:30 AM – 4:45 PM ET
This one-day virtual training delivers the knowledge and tools needed to implement best-in-class procedures in aseptic processing. The elite faculty covers recent changes to Annex 1, aseptic principles, facility design, development, implementation and validation, media fills, data analysis, and inspection readiness.
Top Reasons to Attend
- Understand What the Recent Changes for Annex 1 Mean for You
- Modernize Your Aseptic Processing Procedures
- Knowledge Management – Review Recent 483s and Avoid Non-Compliance
- Learn Effective Design Criteria and Program Maintenance Processes
- Develop and Implement Environmental Control, Cleaning, and Sanitization Programs
- Understand Aseptic Principles, Component Sterilization, and Single Use Technology
- Overcome Common Problems in Sterilization
- Learn Alternative Methods in Aseptic Processing – Isolator Usage, Blow Fill and Seal Technology, Restricted Access Barrier Systems (RABS)
- Learn How to Manage Media Fills – Frequency and Size, Duration, Manipulation, Incubation Methods, Failure Investigations, Corrective Actions, SOPs
- Implement a Risk- and Quality System-based Approach to Aseptic Processes
Personnel in the Following Environments Should Attend:
- QA/QC
- Validation
- Engineering
- Commissioning & Qualification
- Facility and Utility Personnel
- Manufacturing Personnel
- Microbiologist, Scientists
- Regulatory Affairs
This event is also appropriate to business development and sales managers that offer innovative solutions for aseptic processing, cleaning validation, contamination control and consulting professionals in the life science industry.