Sterile Filtration, Media Fill and Environmental Monitoring | Best practice in operation and validation of aseptic processes

Don’t miss out on this chance to be part of this premier sterile processing event in Melbourne. International presenters Russell Madsen (ex PDA President) and Marsha Stabler Hardiman (Val Source) providing relevant expertise on critical hot topics. A mini exhibition from relevant exhibitors will provide an opportunity to make the most of your time. And don’t miss the chance to meet like-minded peer and this premier ISPE event .

Presenters:

Course Details:
Aseptic filling of parenterals is one of the most challenging tasks in pharmaceutical manufacturing and requires a thorough understanding of a wide range of topics including sterile filtration, media fill and environmental monitoring. Strict control of these aspects of processing is required to ensure product sterility, patient safety and compliance. These topics are also continually influenced by new methods and innovations either process or technology wise.

This two-day seminar is designed to provide the latest in proven solutions in aseptic processing, and is intended to be beneficial for both experienced individuals working with parenteral processing and those wishing to develop an understanding of the more advanced considerations, whilst having the opportunity to learn and network with their more experienced peers. You will gain a stronger understanding of the following:

• Sterile filtration and the requirements for use and validation of Sterilising Filters
• Best practice in Risk based Environmental Monitoring and expected updates to the ISO14644 standard
• Aseptic Process Simulations and Intervention Risk Assessments

• Further their understanding of aseptic processing specifically related to sterile filtration, media fill and environmental monitoring
• Expand their awareness of hot topics and recent regulatory trends in this field
• Expand their industry network
  
  

  Agenda	Monday
  09:00	Registration
  09:30	Welcome, Introduction and program overview
  	Session 1a - Risk Based Environmental Monitoring
  	Morning Tea with the Exhibitors
  09:45 - 12:45	Session 2 - Introduction to New Em Risk Assessment Tool EM-REM    (EM-Risk Evaluation Model)
  	Questions and Answers - Sessions 1 & 2
  12:45 - 13:30	Lunch proudly sponsored by AMS
  13:30 - 17:00	Session 3 - Risked based EM (cont)
  	Afternoon Tea with the Exhibitors
  	Session 4a – Sterilizing Filtration of Pharmaceuticals and Biopharmaceuticals:     Structure and Function of Sterilizing Filters
  	Questions and Answers – Session 3 and 4a
  17:00 - 18:00	Networking proudly sponsored by Merck
  	Tuesday
  08:30 - 12:30	Session 4b - Sterilizing Filtration of Pharmaceuticals and Biopharmaceuticals:    Correlation of Microbial Retention and Integrity Testing
  	Morning Tea with the Exhibitors
  	Session 5 - Aseptic Processing Simulations
  	Questions and Answers – Session 4b and 5
  12:20 - 13:15	Lunch  proudly sponsored by Laftech
  13:15 - 16:30	Session 6 – Intervention Risk Assessments
  	Afternoon Tea with the Exhibitors
  	Session 7 - Special Guest Speaker / Presentation
  	Questions and Answers – Session 6 and 7
  16:30	Concluding remarks and wrap up

Cancellations: ISPE reserve the right to change the venue or speakers or program from that described.  We also reserve the right in our absolute discretion and without further liability to cancel the program, in which case all event fees will be refunded. We do not provide refunds if you cancel as this enables us to keep our costs and prices to a minimum.  We suggest you send a replacement.