Aseptic Processing Virtual Training

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.

• 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

Faculty:
JR Humbert – Vice President, Quality, INCOG BioPharma Services
Parsa Famili, MSc – President & CEO, Novatek International
Sheba Zama – Head Of Product Specialists And Training Services, Novatek International
David W. Vincent, MPH, Ph.D. – Chief Scientific Officer, VTI Life Sciences