The PDA Aseptic Manufacturing Excellence Conference 2024, will be held on 15 - 16 October 2024 in Melbourne, Australia.


Target Audience:

Auditors, Biotech Managers, Head of Plant, Head of Quality Compliance, Engineering Managers, Microbiologists, Product Managers, Production Managers, Packaging Specialists, Quality Assurance Managers, Regional Sales Managers, Regulators, Regulatory Inspectors, Quality Control Managers, Quality Operations Managers, Regulatory Specialists, Scientists, Sterile Processing Specialists, Technical Account Specialists, Technical Directors, Unit Managers

Speakers

Stelios Tsinontides

Director of CDER's Office of Pharmaceutical Manufacturing Assessment US FDA

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Daniel Klein

Senior Manager, Technical Services at STERIS

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Andrew Watson

Director of CBE

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Brent Lieffers

Senior Director of Innovation Advocacy at Cytiva

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Andrew Hopkins

Director of Compliance at AbbVie

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Lisa Bennett

GMP Senior Consultant & Trainer at SeerPharma

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Peter Qiu

External Advocacy Lead, APAC at Roche Genentech

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Justine Mann

Chief Executive Officer at CBE Pure Solutions

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Agenda

Registration
Opening Plenary
Evolution of GMPs and Why They Are Important For Aseptic Manufacturing
Aseptic Manufacturing Excellence – What Does This Look Like Through the Lens of Annex 1 Requirements
Panel Discussion and Q&A
Registration
Breakfast Session: Practical Approach to Addressing Microbial Data Deviations
Break
Welcome to Day 2 - Updates from the PDA Australia Chapter and Global PDA Network
Session 6 - Isolator Technology
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Location

NOVOTEL MELBOURNE ON COLLINS
270 Collins Street, Melbourne VIC 3000
Melbourne, Victoria, Australia

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Contact us

For additional event or venue information, please email asia-pacific@pda.orgYou can also reach us at +65 64965504

Sponsors and Partners

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