STERILE MANUFACTURING SYSTEMS

WHO SHOULD ATTEND?

THIS INTENSIVE COURSE IS INTENDED FOR THOSE NEW TO THE TOPICS OF PARENTERAL PRODUCT DEVELOPMENT AND ASEPTIC MANUFACTURING AND THOSE NEEDING A REFRESHER ON THE TOPICS AS WELL AS THOSE SEEKING CONFIRMATION OF ACCEPTABILITY OF EXISTING PRACTICES.

IT WILL BE OF PARTICULAR VALUE TO THOSE IN:    

• MANUFACTURING/PRODUCTION
• RESEARCH& DEVELOPMENT
• QUALITY ASSURANCE AND CONTROL

COURSE OBJECTIVES:

UPON COMPLETION OF THIS COURSE, YOU WILL BE ABLE TO:  

• LIST THE REGULATORY CHALLENGES THAT MUST BE CONSIDERED AT sterile FACILITY    
• IDENTIFY THE BASIC CONCEPTS APPLYING TO PROCESSING OF STERILE  DESIGN.    
• MODIFY AND CONTROL A PROCESS TO PRODUCE PRODUCTS THAT HAVE THE DESIRED PROPERTIES

COURSE TOPICS:    

• INFRASTRUCTURE & FACILITIES    
• STERILE FORMULATION    
• STERILE PROCESSES, EQUIPMENT & VISUAL INSPECTION   
• STERILE PRODUCTS FROM QUALITY PERSPECTIVE

            -ENVIRONMENTAL MONITORING
            -MEDIA FILL
            -IN-PROCESS CONTROL

Instructors:

Dr. Mohamed Eissa Dr. Akram Bashir

Dr. Shady Nabil Dr. Mohamed Saad

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