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Event Details

The ISPE Australasian Affiliate PDA Australia Chapter are excited to present our annual joint Aseptic Processing Summit in Melbourne on 19th and 20th Sep 2019. As always, we hope to provide the ideal forum to discuss some of the challenges which face us in our industry and look at ways that these may be handled internationally. The event this year will bring some key international experts representing our leading industry associations with a focus on Aseptic Process and Facility Design, and Contamination Control Practices. We will take a look at emerging Global GMP regulations, current industry standards and some exciting new approaches to meeting our product quality requirements. 

AGENDA

Thursday 19th Sep - Aseptic Processing & Facility Design*
08:00 – 08:30 Registration and coffee
08:30 – 08:45 Welcome and Introductory Remarks Richard Denk
08:45 – 09:30 FDA-EMA Aseptic Requirements Annex 1 Richard Denk
09:30 – 10:00 Aseptic Processing ISO Requirements TBA
10:00 – 10:30 Break
10:30 – 11:15 Requirements for Highly Potent/toxic Aseptic Processing Richard Denk
11:15 – 12:00 Aseptic Isolator Design, Air Handling Unit Richard Denk
12:00 – 13:00 Lunch – Sponsor TBC
13:00 – 13:30 Cycle Development/Decontamination Cycle for H2O2 Richard Denk
13:30 – 14:00 PUPSIT Micheal Schafferius
14:00 – 14:45 Dispensing of Highly Potent Substances and Special Aseptic Processes Koji Ushioda
14:45 – 15:15 Break
15:15 – 15:45 Modular Aseptic Fill & Finish Application Koji Ushioda
15:45 – 16:15 GMP Requirements for Stopper Processing Thomas Jochimsen
16:15 – 17:00 Cleaning Requirements of Non-product Contact Surfaces in Aseptic Isolators and Cross Contamination Requirements Richard Denk
17:00 – 17:20 Q&A All speakers
17-20 – 19:00 Networking drinks and canapés Sponsored event

Friday 20th Sep - Contamination Control & Risk Based Cleaning and Disinfection*
08:00 – 08:30 Registration and coffee
08:30 – 08:45 Welcome and Introductory Remarks Jim Polarine
08:45 – 09:30 A Risk Based Cleaning and Disinfection Program Jim Polarine
10:00 – 10:30 Break
10:30 – 12:00 Contamination Control in Process Equipment - Biofilm Generation and Remediation Richard Chai
12:00 – 13:00 Lunch – Sponsor TBC
13:00 – 14:00 Current Debates and Challenges Regarding Disinfectant Validation and Methods to Circumvent Them Jim Polarine
14:00 – 14:45 Case Studies - Rouge Formation and Remediation Richard Chai
14:45 – 15:15 Break
15:15 – 16:00 Case Studies in Fungal and Bacterial Spore Excursions Using a Risk Based Approach Jim Polarine
16:00 – 16:45 Cleanroom Start Up and Bringing the Cleanroom Online After Worst Case Events Richard Chai
16:45 – 17:00 Q&A and Summit Session Close Jim Polarine & Richard Chai

*Schedule times may be varied during the course with the agreement of delegates to ensure content is adequately covered 

Further details can be found here

https://www.stickytickets.com.au/89027
map
Victoria University City Convention Centre

Level 12/300 Flinders Street Melbourne Melbourne 3000, Australia

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Organiser Information

Mandy Bromilow
ISPE
0447279008

Ask the organiser
Refund Policy

If you cancel within 30 days you will receive a full refund less an admin fee of $150. After 30 days you can substitute your booking with another attendee.