PDA Australia Aseptic Processing Summit
Registration Options
Individual Registration
Group Registration
The ISPE Australasian Affiliate and PDA Australia Chapter are excited to present our annual joint Aseptic Processing Summit in Melbourne. 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.
Who Should Attend
- Quality control staff, microbiologists, operations managers, cleanroom managers, regulatory managers, and validation practitioners, engineers, managers and staff involved in the manufacture of sterile/non-sterile medicinal products or medical devices.
- Technical professionals, management, vendors and operations personnel who support sterile manufacturing operations.
Why you Should Attend
- Understand the best practice for sterile manufacture and expectations, including emerging global regulatory views in the US and EU.
- An overview of essential factors underpinning successful sterile manufacturing facilities and operations
- An update on current developments in sterile manufacturing generally
- Case studies and current industry best practices in contamination control and cleaning and disinfection
Event Location
Standard Pricing
Standard Member Price
$1,050Day 1
Aseptic Processing & Facility Design
- 8:00 a.m. Registration and Coffee Refreshments
- 8:30 a.m. Welcome and Introductory Remarks
Richard Denk, SKAN AG - 8:45 a.m. - 9:30 a.m. FDA- EMA Aseptic Requirements Annex 1
Richard Denk, SKAN AG - 9:30 a.m. - 10:00 a.m. Aseptic Processing ISO Requirements
TBD - 10:00 a.m. - 10:30 a.m.Networking Break
- 10:30 a.m. - 11:15 a.m. Requirements for Highly Potent/ Toxic Aseptic Processing
Richard Denk, SKAN AG - 11:15 a.m. - 12:00 p.m. Aseptic Isolator Design and Air Handling Unit
Richard Denk, SKAN AG - 12:00 p.m. - 13:00 p.m. Lunch
Sponsor TBD - 13: 00 p.m. - 13:30 p.m. Cycle Development/Decontainment Cycle for H202
Richard Denk, SKAN AG - 13:30 p.m. - 14:00 p.m. PUPSIT
Micheal Schafferius, Sartorius Stedium Biotech Australia - 14:00 p.m. - 14:45 p.m. Dispensing of Highly Potent Substances and Special Aseptic Processes
Koji Ushioda - 14:45 p.m. - 15:45 p.m. Networking Break
- 15:15 p.m. Modular Aseptic Fill & Finish Application
Thomas Jochimsen, Atec Steritech GmbH - 15:45 p.m. - 16:15 p.m. Requirements of Non-Product Contact Surfaces
Koji Ushioda - 16:15 p.m. - 17:00 p.m. Cleaning Requirements of Non-product Contact Surfaces in Aseptic Isolators and Cross Contamination Requirements
Richard Denk, SKAN AG - 17:00 p.m. -17:20 p.m. Q & A with all Speakers
- 17:20 p.m. - 19:00 p.m. Networking, Refreshments, and Canapes
Day 2
Contamination Control & Risk Based Cleaning and Disinfection
- 8:30 a.m. - 8:40 a.m.Welcome and Introductory Remarks
Jim Polarine Jr., STERIS Corporation - 8:40 a.m. - 10:10 a.m. A Risk Based Cleaning and Disinfection Program
Jim Polarine Jr., STERIS Corporation - 10:10 a.m. - 10:40 a.m. Networking Break
- 10:40 a.m. - 12:00 p.m. Case Studies - Rouge Formation and Remediation
Richard Chai, STERIS Corporation - 12:00 p.m. - 13:00 p.m. Lunch
Sponsor TBD - 13:00 p.m. - 14:00 p.m. Current Debates and Challenges Regarding Disinfectant Validation and Methods to Circumvent hem
Jim Polarine Jr., STERIS Corporation - 14:00 p.m. - 14:45 p.m. Contamination Control in Process Equipment - Biofilm Generation and Remediation
Richard Chai, STERIS Corporation - 14:45 p.m. - 15:15 p.m. Networking Break
- 15:15 p.m. - 16:00 p.m. Case Studies in Fungal and Bacterial Spore Excursions using a Risk Based Approach;
Richard Chai, STERIS Corporation - 16:00 p.m. - 16:45 p.m. Cleanroom Start Up and Bringing the Cleanroom Online After Worst Case Events
Richard Chai, STERIS Corporation - 16:45 p.m. - 16:55 p.m. Q & A with Jim Polarine Jr.and Richard Chai
- 16:55 p.m. Session Ends
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Victoria University City Convention Centre (Take the elevator to Level 12)
300 Finders StreetMelbourne, Australia ,