AGENDA
10:45 AM ET
Chairperson's Welcome and Opening Remarks
Howard Wilensky, Executive Director, KENX
11:00 AM - 12:00 PM ET
Annex 1 Contamination Control – What the Recent Revision Mean
Parsa Famili, President and CEO, Novatek International
12:00 - 12:15 PM ET
Refreshment Break
12:15 - 1:45 PM ET
Development, Validation and Management of an Aseptic Program
David W. Vincent, B.Sc., MPH, Ph.D., CEO, VTI Life Sciences
1:45 - 2:00 PM ET
Refreshment Break
2:00 – 3:30 PM ET
Data Analysis and Trending in AP
Sheba Zaman, Head of Product Specialists &Training Services Novatek International
3:30 - 3:45 PM ET
Refreshment Break
3:45 – 4:45 PM ET
Preparing for and Handling FDA Inspections on your Aseptic Processing and Packaging Machines
JR Humbert, Senior Director of Quality, INCOG BioPharma
SPONSORED BY
Aseptic Processing
Development, Implementation, and Validation
December 13, 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.
