Analytical method development, optimization and validation

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 &GMP;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    I. INFRASTRUCTURE: A. FACILITIES, UTILITIES& ENVIRONMENTAL MONITORING    2. STERILE FORMULATION    3. STERILE PROCESSES & EQUIPMENT    4.FILLING,INSPECTION&  PACKAGING  Instructors: Dr. Mohamed Saad   Dr. Akram Bashir