PDA Australia Aseptic Processing Summit

Melbourne, Australia
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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

Standard Registration

Member Price


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

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

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

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 Street
Melbourne, Australia ,