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PDA Australia Aseptic Processing Summit

Sep 19 - Sep 20, 2019
Melbourne, Australia

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Overview

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

Agenda

  • Day 1
  • Day 2
  • 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. 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. 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
  • Contamination Control & Risk Based Cleaning and Disinfection

    • 8:00 a.m. Registration and Coffee
    • 8:30 a.m. Welcome and Introductory Remarks 
      Jim Polarine, STERIS Corporation
    • 8:45 a.m. - 9:30 a.m. A Risk Based Cleaning and Disinfection Program
      Jim Polarine, STERIS Corporation
    • 9:30 a.m. - 10:00 a.m. Aseptic Processing ISO Requirements
      TBD
    • 10:00 a.m. - 10:30 a.m. Break
    • 10:30 a.m. - 12:00 p.m. Contamination Control in Process Equipment - Biofilm Generation 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 them 
      Jim Polarine, STERIS Corporation
    • 14:00 p.m. - 14:45 p.m. Case Studies - Rouge Formation and Remediation 
      Richard Chai, STERIS Corporation
    • 14:45 p.m. - 15:45 p.m. Break
    • 15:15 p.m. - 16:00 p.m. Case Studies in Fungal and Bacterial Spore Excursions using a Risk Based Approach 
      Jim Polarine, STERIS Corporation
    • 16:00 p.m. - 16:45 p.m. Cleanroom start- up and bringing the cleanroom online After Worst Case Events 
      Koji Ushioda, SKAN JAPAN Corporation 
    • 16:45 p.m. - 17:00 p.m. Q & A with Jim Polarine and Richard Chai and Summit Closing Remarks
    * Schedule times may be varied during the course with the agreement of delegates to ensure content is adequately covered

Highlighted Speakers

Richard Chai
Richard Chai
STERIS Corporation
Richard  Denk
Richard Denk
Skan AG
Thomas  Jochimsen
Thomas Jochimsen
Atec Steritec GmbH
James Polarine, Jr. MA
James Polarine, Jr. MA
Steris Corporation
Micheal  Schafferius
Micheal Schafferius
Sartorius Stedim Biotech Australia

Travel

Victoria University City Convention Centre (Take the elevator to Level 12)

300 Finders Street
Melbourne, Australia

Directions

Registration Fees

Early Registration Price
Registration Type Price by September 5
PDA Member $850
PDA Non-member $1,100
Regular Registration Price
Registration Type Price after September 6
PDA Member $1,050
PDA Non-member $1,300

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