Registration
Opening Plenary
Evolution of GMPs and Why They Are Important For Aseptic Manufacturing
Andrew Hopkins
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie
Aseptic Manufacturing Excellence – What Does This Look Like Through the Lens of Annex 1 Requirements
Brent Lieffers
  • Brent Lieffers (Senior Director of Innovation Advocacy at Cytiva)

    Brent Lieffers

    Senior Director of Innovation Advocacy at Cytiva
Panel Discussion and Q&A
Andrew HopkinsBrent Lieffers
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie
  • Brent Lieffers (Senior Director of Innovation Advocacy at Cytiva)

    Brent Lieffers

    Senior Director of Innovation Advocacy at Cytiva
Coffee Break at the Exhibition Hall
Session 1Regulatory Authorities Collaboration

Welcome Remarks by the Moderator

International Coalition of Medicines Regulatory Authorities (ICMRA) Collaborative Hybrid Inspection Pilot (CHIP) Program
Stelios Tsinontides (invited)
  • Stelios Tsinontides (invited) (Director of CDER's Office of Pharmaceutical Manufacturing Assessment US FDA)

    Stelios Tsinontides (invited)

    Director of CDER's Office of Pharmaceutical Manufacturing Assessment US FDA
ICMRA CHIP The Industry Perspective
Andrea Kurz

This presentation gives an overview about the ICMRA’s Collaborative Hybrid Inspection Pilot (CHIP) from the Industry’s Perspective. The CHIP provides an opportunity to reach agreement from multiple authorities on the compliance of a site with a single inspection activity.
This presentation illustrates a companies’ journey in preparing, organising and hosting a CHIP inspection performed jointly by multiple authorities under the lead of an on-site inspectorate. It talks about the challenges, opportunities and benefits of the CHIP and ultimately how such pilot can further support reliance and convergence efforts.

  • Andrea Kurz (Vice Director, External Collaboration Europe of F. Hoffmann-La Roche Ltd)

    Andrea Kurz

    Vice Director, External Collaboration Europe of F. Hoffmann-La Roche Ltd
Q&A Session
Stelios Tsinontides (invited)Andrea Kurz
  • Stelios Tsinontides (invited) (Director of CDER's Office of Pharmaceutical Manufacturing Assessment US FDA)

    Stelios Tsinontides (invited)

    Director of CDER's Office of Pharmaceutical Manufacturing Assessment US FDA
  • Andrea Kurz (Vice Director, External Collaboration Europe of F. Hoffmann-La Roche Ltd)

    Andrea Kurz

    Vice Director, External Collaboration Europe of F. Hoffmann-La Roche Ltd
Session 2Veterinary Medicine Regulation and Manufacture

Welcome Remarks by the Moderator

Topic: TBC
Malcolm Hammond
  • Malcolm Hammond (APVMA)

    Malcolm Hammond

    APVMA
Trends in Veterinary Medicine Manufacture
Austin Caudle (invited)
  • Austin Caudle (invited) (Redica)

    Austin Caudle (invited)

    Redica
Q&A Session
Malcolm HammondAustin Caudle (invited)
  • Malcolm Hammond (APVMA)

    Malcolm Hammond

    APVMA
  • Austin Caudle (invited) (Redica)

    Austin Caudle (invited)

    Redica
Lunch Break
Session 3It All Begins with Good Design

Welcome Remarks by the Moderator

Cleanroom Design for Housing Isolators & Modular Cleanrooms: Opportunities & Challenges
Andrew Watson

This presentation will discuss the requirements for cleanroom design, focusing on the requirements for facilities that want to perform aseptic processes in isolators. It will cover general design concepts regarding layouts, sizing, detailing, HVAC, critical services, controls and alarms. Budgeting and scheduling will also be touched on. Finally, a discussion on the opportunities and hazards of portable facilities. This emerging trend provides significant benefits for some, but not all projects.

  • Andrew Watson (Director of CBE)

    Andrew Watson

    Director of CBE
Management of Facility and Critical Utility Systems: Contamination Control Strategies
Kim Sobien
  • Kim Sobien (Senior Microbiology Consultant at ValSource)

    Kim Sobien

    Senior Microbiology Consultant at ValSource
Q&A Session
Kim SobienAndrew Watson
  • Kim Sobien (Senior Microbiology Consultant at ValSource)

    Kim Sobien

    Senior Microbiology Consultant at ValSource
  • Andrew Watson (Director of CBE)

    Andrew Watson

    Director of CBE
Session 4Case Studies Using Data Analytics to Achieve Manufacturing Excellence

Welcome Remarks by the Moderator

Case Study 1Learning Journey with SmartSkin
Case Study 2Regulatory Trending / Intelligence
Q&A Session
Coffee Break at the Exhibition Hall
Session 5Establishing Programs Supporting the Contamination Control Strategy

Welcome Remarks by the Moderator

Establishing a Cleaning & Disinfection Program
Dan Klein
  • Dan Klein (Senior Technical Service Manager at STERIS)

    Dan Klein

    Senior Technical Service Manager at STERIS
Environmental Monitoring Risk Assessments and Program Development
Kim Sobien
  • Kim Sobien (Senior Microbiology Consultant at ValSource)

    Kim Sobien

    Senior Microbiology Consultant at ValSource
Q&A Session
Dan KleinKim Sobien
  • Dan Klein (Senior Technical Service Manager at STERIS)

    Dan Klein

    Senior Technical Service Manager at STERIS
  • Kim Sobien (Senior Microbiology Consultant at ValSource)

    Kim Sobien

    Senior Microbiology Consultant at ValSource
Day 1 Closing Remarks
Networking Reception
Registration
Breakfast Session: Practical Approach to Addressing Microbial Data Deviations
Andrew HopkinsKim SobienBrent Lieffers
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie
  • Kim Sobien (Senior Microbiology Consultant at ValSource)

    Kim Sobien

    Senior Microbiology Consultant at ValSource
  • Brent Lieffers (Senior Director of Innovation Advocacy at Cytiva)

    Brent Lieffers

    Senior Director of Innovation Advocacy at Cytiva
Break
Welcome to Day 2Updates from the PDA Australia Chapter and Global PDA Network
Session 6Isolator Technology

Welcome Remarks by the Moderator

Implementation and Use of Isolators – Challenges and Opportunities
Brent Lieffers
  • Brent Lieffers (Senior Director of Innovation Advocacy at Cytiva)

    Brent Lieffers

    Senior Director of Innovation Advocacy at Cytiva
Incorporating Vaporised Hydrogen Peroxide into the Contamination Control Strategy
Dan Klein
  • Dan Klein (Senior Technical Service Manager at STERIS)

    Dan Klein

    Senior Technical Service Manager at STERIS
Panel Discussion and Q&A
Dan KleinBrent Lieffers
  • Dan Klein (Senior Technical Service Manager at STERIS)

    Dan Klein

    Senior Technical Service Manager at STERIS
  • Brent Lieffers (Senior Director of Innovation Advocacy at Cytiva)

    Brent Lieffers

    Senior Director of Innovation Advocacy at Cytiva
Coffee Break
Session 7Testing to Ensure Purity and Integrity of Parenterals

Welcome Remarks by the Moderator

US FDA Guidance document on Visual Inspection of Parenteral
Peter Qiu
  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
Quality Risk Management and the Future of Container Closure Integrity
Anthony Georgiadis
  • Anthony Georgiadis (Sales Director of Amscorp Scientific)

    Anthony Georgiadis

    Sales Director of Amscorp Scientific
Panel Discussion and Q&A
Anthony GeorgiadisPeter Qiu
  • Anthony Georgiadis (Sales Director of Amscorp Scientific)

    Anthony Georgiadis

    Sales Director of Amscorp Scientific
  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
Lunch Break
Session 8Expert Insights Unveiled: Ask Our Expert Minds!

Welcome Remarks by the Moderator

Facilitated Discussion on the Challenges in Achieving Aseptic Manufacturing Excellence
Dan KleinPeter QiuKim SobienBrent Lieffers
  • Dan Klein (Senior Technical Service Manager at STERIS)

    Dan Klein

    Senior Technical Service Manager at STERIS
  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
  • Kim Sobien (Senior Microbiology Consultant at ValSource)

    Kim Sobien

    Senior Microbiology Consultant at ValSource
  • Brent Lieffers (Senior Director of Innovation Advocacy at Cytiva)

    Brent Lieffers

    Senior Director of Innovation Advocacy at Cytiva
Session 9Case Studies

Welcome Remarks by the Moderator

Case Study 1Rapid Microbial Methods

CBE Pure Solutions

Case Study 2
Case Study 3
Panel Discussion and Q&A
Coffee Break
Session 10Insights from the Therapeutic Goods Administration

Welcome Remarks by the Moderator

Topic: TBC

Speaker: TBC

Q&A Session
Closing Remarks

The information presented at this conference is accurate as of its launch date. However, the organizers retain the right to modify, update, or amend any details as needed. As we aim to provide the most current information and updates, we encourage you to check regularly for any changes.