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PDA Australia Chapter Annex 1 Update, TGA Adoption of PIC/S PE 009-13, and Cleanroom Evolution Dinner Meeting

Jul 18 - Jul 18, 2017 |
Jul 18, 2017 |
The Manningham Hotel & Club | Bulleen, VIC
  • Chapter
  • Asia-Pacific
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The PDA Australia Chapter is pleased to invite members and non-members to attend our dinner meeting on the pending Annex 1 update, TGA adoption of PIC/S PE 009-13 and cleanroom evolution on Tuesday the 18th of July.  The event will take place at The Manningham Hotel & Club, Bulleen, Melbourne.

About the Speakers

Andrew Watson is a past president of ISPE (Australasia) and is currently is Independent Chair of ME-060 (Cleanroom Standards) for Standards Australia.  He is the Australian recognised expert for cleanrooms for TC-209 which oversees the ISO 14644 and 14698 suite of standards.  He is also a director of CBE Pty Ltd.

Andrew's presentation titled “Facility Operation and Monitoring – Evolution not Revolution“ will look at the new standards and demonstrate how they will help you understand your facility and successfully navigate the new requirements.  Impending changes to the cleanroom testing industry will also be discussed and how this means the users now have a greater responsibility.  Finally, Andrew will look at a newly proposed standard that may truly revolutionise our industry and what that change might look like.

Neale Baldwin is a Team Leader/Senior Inspector from the Inspections and Compliance Manufacturing Quality Branch of the TGA. Neale will present on TGA adoption of PIC/S PE 009-13 and impending revision to Annex 1

Neale's presentation will provide an update on the proposed adoption of version 13 of the PIC/S Code of GMP. The TGA will also provide an update on the status of Annex 1. More details will follow.

Eoin Hanley is currently a Quality Assurance Projects Compliance Manager with CSL Behring and is President-Elect of the PDA Australia Chapter. Eoin will host round table discussions on aseptic processing and Annex 1 topics from global events and get a measure of where the industry in Australia is at. Eoin will also share feedback from these global PDA events on challenges in aseptic processing and changes to Annex 1.

Agenda

5:30pm – 6:00pm Registration.
6:00pm - 7:30pm Speakers.
7:30pm - 9:30pm Dinner, wrap up, questions and conclusion.

Registration

Fees:          PDA Members: $90         Non-members: $130

Registration and payment must be received by 30 June 2017 to secure attendance.

Please register early as places are limited!

Parking is available at the hotel.

If you have any special dietary requirements, please advise us prior to the event.

On-line Registration and Payment by credit card:

Please click on this link to register

Manual Registration and Payment by EFT:

Please complete this Form and email to David Spaulding at david.spaulding@seerpharma.com.au

Would you like to sponsor a PDA Australia event?

If you would like to sponsor this event or future events, please contact us for further information.

Register Now
https://www.trybooking.com/book/event?eid=287566

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