at Victoria University City Convention Centre
Thursday, 19 September 2019 from 8:00 AM - Friday, 20 September 2019 to 5:00 PM (AUS Eastern Standard Time) + Add to calendar19/09/2019 08:0020/09/2019 17:00Australia/Sydney2019 ASEPTIC PROCESSING SUMMIT2019 ASEPTIC PROCESSING SUMMIT
Thursday, 19 September 2019 from 8:00 AM - Friday, 20 September 2019 to 5:00 PM (AUS Eastern Standard Time)
Organiser
Mandy Bromilow
0447279008
manager@ispe.org.au
Address
Victoria University City Convention Centre
Level 12/300 Flinders Street
Melbourne
Melbourne 3000 Australia
Event web page: https://www.stickytickets.com.au/89027Victoria University City Convention Centre
Level 12/300 Flinders Street
Melbourne Melbourne 3000
AustraliaMandy BromilowfalseDD/MM/YYYY2880
Tickets for this event are currently unavailable
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
Refunds up to 30 days before the event, 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.
Level 12/300 Flinders Street Melbourne Melbourne 3000, Australia
Mandy Bromilow
ISPE
0447279008
