Registration
Opening Plenary
Lisa Bennett

Good Manufacturing Practices (GMPs) have significantly evolved over time into the current GMPS (cGMPs) we have today in order to ensure the safety, quality and efficiency of pharmaceutical products. In the beginning, GMPs took shape in response to public health tragedies caused by contaminated or poorly manufactured drugs, highlighting the need for rules around manufacture in order to protect the patient. The next major step in evolution to cGMPs resulted from efforts to harmonise GMP standards across the differing global markets. Changes reflect the industry ongoing commitment to ensuring patient safety through the provision of quality products.

How have these changes shaped cGMPs for drug manufacture and how do we achieve aseptic manufacturing excellence in accordance with cGMPs and the requirements of Annex 1 for the Manufacture of Sterile Medicinal Products? These questions will be explored throughout the program beginning with this plenary session featuring Andy Hopkins who was instrumental in drafting the latest revision to Annex during his time with the UK Medicines and Healthcare products Regulatory Agency (MHRA).

  • Lisa Bennett (GMP Senior Consultant & Trainer at SeerPharma)

    Lisa Bennett

    GMP Senior Consultant & Trainer at SeerPharma
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 Hopkins•Brent 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 1 • Regulatory Authorities Collaboration
Peter Qiu

Efforts with global harmonisation in GMPs began over 40 years ago with significant contributions from organisations such as the World Health Organisation (WHO), The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the International Cooperation on Harmonisation (ICH).

Regulatory agencies have long been collaborating to keep up with the demands of the global pharmaceutical industry by fostering opportunities for communication and collaboration by establishing initiatives such as Mutual Recognition Agreements (MRAs) to streamline regulatory oversight.

The International Coalition of Medicines Regulatory Authorities (ICMRA) have been working on further collaborative indicatives with their Pharmaceutical Quality Knowledge Management (PQKM) Pilot Programmes including the Collaborative Hybrid Inspection Pilot (CHIP). With the last of three hybrid inspections executed in May 2024 representatives involved on both sides of the proverbial fence will share their experiences.

  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
International Coalition of Medicines Regulatory Authorities (ICMRA) Collaborative Hybrid Inspection Pilot (CHIP) Program
Stelios Tsinontides
  • Stelios Tsinontides (Director of CDER's Office of Pharmaceutical Manufacturing Assessment US FDA)

    Stelios Tsinontides

    Director of CDER's Office of Pharmaceutical Manufacturing Assessment US FDA
ICMRA Collaborative Hybrid Inspection Pilot (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 (Senior Director, External Advocacy Europe and Middle East of F. Hoffmann-La Roche Ltd)

    Andrea Kurz

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

    Stelios Tsinontides

    Director of CDER's Office of Pharmaceutical Manufacturing Assessment US FDA
  • Andrea Kurz (Senior Director, External Advocacy Europe and Middle East of F. Hoffmann-La Roche Ltd)

    Andrea Kurz

    Senior Director, External Advocacy Europe and Middle East of F. Hoffmann-La Roche Ltd
Session 2 • Veterinary Medicine Regulation and Manufacture
Justine Mann

The regulation of veterinary medicine manufacture still varies globally despite efforts to harmonise GMPs by regulators and global organisations such as the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the Veterinary International Conference on Harmonisation (VICH). Variations in the way regulatory agencies classify and regulate veterinary medicines create further challenges with efforts on harmonisation.
Representatives from the Australian regulator the Australia Pesticides Veterinary Medicine Manufacture (AMVPMA) and APVMA auditors will provide an update on APVMA expectations, frequently identified issues and changes on the horizon for veterinary medicine manufacture.

  • Justine Mann (Chief Executive Officer at CBE Pure Solutions)

    Justine Mann

    Chief Executive Officer at CBE Pure Solutions
APVMA Licensing for Veterinary Medicines
Malcolm Hammond

This presentation will explore:
• Commonly asked questions related to the cGMP applicable to APVMA license holders.
• What are the Licence holder’s responsibilities and obligations under the existing legislation and
regulation?
• Certificate of Export for Veterinary Medicines.
• Veterinary vaccines using platform technology master files (vPTMF).

  • Malcolm Hammond (Director, Manufacturing Quality and Licensing & Assurance (AERP | Recalls | HGP) of Australian Pesticides and Veterinary Medicines Authority)

    Malcolm Hammond

    Director, Manufacturing Quality and Licensing & Assurance (AERP | Recalls | HGP) of Australian Pesticides and Veterinary Medicines Authority
Trends in Veterinary Medicine Manufacture
Steve Williams
  • Steve Williams (Director of SWA Biopharm P/L)

    Steve Williams

    Director of SWA Biopharm P/L
Q&A Session
Malcolm Hammond•Steve Williams
  • Malcolm Hammond (Director, Manufacturing Quality and Licensing & Assurance (AERP | Recalls | HGP) of Australian Pesticides and Veterinary Medicines Authority)

    Malcolm Hammond

    Director, Manufacturing Quality and Licensing & Assurance (AERP | Recalls | HGP) of Australian Pesticides and Veterinary Medicines Authority
  • Steve Williams (Director of SWA Biopharm P/L)

    Steve Williams

    Director of SWA Biopharm P/L
Lunch Break
Session 3 • It All Begins with Good Design

Contamination Control Strategy - it all starts with good cleanroom design. Manufacturing facilities should be appropriately designed to protect medicinal products from potential sources of endotoxin/pyrogen, particulate and microbial contamination. Eudralex / PIC/S Annex 1 encourages the use appropriate barrier technologies such as isolators to increase protection of the product from such contamination. The separation of product from some of the highest risks present in a cleanroom (yes you - people!) creates opportunities and challenges for our aseptic operations. This session will explore some of these opportunities and challenges along with how our cleanroom design might change to accommodate the use of isolator technology.

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
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
Q&A Session
Andrew Watson•Brent Lieffers
  • Andrew Watson (Director of CBE)

    Andrew Watson

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

    Brent Lieffers

    Senior Director of Innovation Advocacy at Cytiva
Session 4 • Case Studies
Nadia Seidel

This is the first of two case study sessions providing an opportunity for companies to share a new process or technology they have successfully implemented, whilst often applying problem solving skills, navigating challenges and learning from mistakes.
Whether it be the use of data analytics, technologies or automating processes these implementations help to achieve manufacturing excellence.
These thought-provoking case studies provide an opportunity for contextual learning from others, whom we guarantee you’ll want to talk further with during the afternoon break immediately following the session.

  • Nadia Seidel (Site Operational Excellence Lead at Pfizer)

    Nadia Seidel

    Site Operational Excellence Lead at Pfizer
Case Study 1: Our Learning journey: Vial Drones improving line Operational Efficiencies (with Smartskin)
Andrew Treller•William Dyer

Analyzing the impact of various forces on our vials during their journey through machinery has always posed a challenge. However, the introduction of new vial drone technology has improved our line operational efficiency. This advancement has led to a reduction in manual interventions, enhanced machine performance, and a decrease in the number of rejected vials, thereby boosting productivity and saving time.

  • Andrew Treller (Continuous Improvement Specialist, High potent - Production at Pfizer)

    Andrew Treller

    Continuous Improvement Specialist, High potent - Production at Pfizer
  • William Dyer (Operational Excellence Associate, Operational Excellence at Pfizer)

    William Dyer

    Operational Excellence Associate, Operational Excellence at Pfizer
Case Study 2 • Automating Single Use Pre Use Post Sterilisation Integrity Testing (PUPSIT)
Micheal Schafferius

The regulatory requirement for Pre Use post Sterilisation Integrity Testing (PUPSIT) has been with us now for many years. The recent review and release of EU GMP Annex 1 has re-focused attention on PUPSIT for many Regulators, Auditors and ultimately manufacturers. This case study will look at the implementation of PUPSIT in a single use process setting with automation.

  • Micheal Schafferius (Application Specialist for Separation Technologies and Quality at SARTORIUS)

    Micheal Schafferius

    Application Specialist for Separation Technologies and Quality at SARTORIUS
Q&A Session
Micheal Schafferius•Andrew Treller•William Dyer
  • Micheal Schafferius (Application Specialist for Separation Technologies and Quality at SARTORIUS)

    Micheal Schafferius

    Application Specialist for Separation Technologies and Quality at SARTORIUS
  • Andrew Treller (Continuous Improvement Specialist, High potent - Production at Pfizer)

    Andrew Treller

    Continuous Improvement Specialist, High potent - Production at Pfizer
  • William Dyer (Operational Excellence Associate, Operational Excellence at Pfizer)

    William Dyer

    Operational Excellence Associate, Operational Excellence at Pfizer
Coffee Break at the Exhibition Hall
Session 5 • Establishing Programs Supporting the Contamination Control Strategy
Mylinh La

Welcome Remarks by the Moderator

  • Mylinh La (Senior Lab Manager at CSIRO)

    Mylinh La

    Senior Lab Manager at CSIRO
Establishing a Cleaning & Disinfection Program
Daniel Klein
  • Daniel Klein (Senior Manager, Technical Services at STERIS)

    Daniel Klein

    Senior Manager, Technical Services 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
Daniel Klein•Kim Sobien
  • Daniel Klein (Senior Manager, Technical Services at STERIS)

    Daniel Klein

    Senior Manager, Technical Services 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
Kim Sobien
  • Kim Sobien (Senior Microbiology Consultant at ValSource)

    Kim Sobien

    Senior Microbiology Consultant at ValSource
Break
Welcome to Day 2 • Updates from the PDA Australia Chapter and Global PDA Network
Session 6 • Isolator Technology

Welcome Remarks by the Moderator

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
Disinfectant Testing and Test Methods
Daniel Klein
  • Daniel Klein (Senior Manager, Technical Services at STERIS)

    Daniel Klein

    Senior Manager, Technical Services at STERIS
Panel Discussion and Q&A
Daniel Klein•Kim Sobien
  • Daniel Klein (Senior Manager, Technical Services at STERIS)

    Daniel Klein

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

    Kim Sobien

    Senior Microbiology Consultant at ValSource
Coffee Break
Session 7 • Testing to Ensure Purity and Integrity of Parenterals

Welcome Remarks by the Moderator

How to Develop a Robust Visual Inspection Program for Visible Particulates
Peter Qiu

The US FDA published a draft guidance on Inspection of Injectable Products for Visible Particulates in 2021. In the draft guidance, the Agency states that meeting the acceptance criteria outlined in USP General Chapter (790), is not alone sufficient to ensure compliance with the applicable CGMP requirements and full compliance with CGMP requirements is needed to ensure the continued supply of pure, safe, and effective injectable products. This presentation will discuss regulatory expectations on how to develop and implement a visual inspection program and also share case studies on common deficiencies found during regulatory inspections for injectable products.

  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
Ensuring Container Closure Integrity Throughout the Product Lifecycle
Anthony Georgiadis

This presentation discusses the regulatory landscape surrounding Container Closure Integrity Testing (CCIT). I will delve into Annex 1, highlighting the recent updates and its regulatory significance. We will explore how regulations shape CCIT strategies and the application of various CCIT methods throughout a product's lifecycle. The discussion will cover critical factors to consider when selecting appropriate methods at different stages of the product lifecycle. By providing a detailed understanding of these aspects, the presentation aims to guide manufacturers on container closure integrity testing in strict compliance with regulatory standards

  • Anthony Georgiadis (Sales Director of Amscorp Scientific)

    Anthony Georgiadis

    Sales Director of Amscorp Scientific
Panel Discussion and Q&A
Anthony Georgiadis•Peter 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 8 • Ask an Expert
Lisa Bennett

This session provides an opportunity for attendees to discuss key topics or scenarios with challenges in achieving aseptic manufacturing excellence and take away ideas for solutions or clarification on these challenges. Attendees will be given the opportunity to submit topics for discussion prior to the event with the hottest topics to be polled during the session and the most popular topics discussed.

  • Lisa Bennett (GMP Senior Consultant & Trainer at SeerPharma)

    Lisa Bennett

    GMP Senior Consultant & Trainer at SeerPharma
Facilitated Discussion on the Challenges in Achieving Aseptic Manufacturing Excellence
Brent Lieffers•Peter Qiu•Kim Sobien•Daniel Klein
  • Brent Lieffers (Senior Director of Innovation Advocacy at Cytiva)

    Brent Lieffers

    Senior Director of Innovation Advocacy at Cytiva
  • 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
  • Daniel Klein (Senior Manager, Technical Services at STERIS)

    Daniel Klein

    Senior Manager, Technical Services at STERIS
Session 9 • Case Studies • Using Data Analytics to Achieve Manufacturing Excellence
Craig Stephens

The second of our case study sessions providing an opportunity for companies to share a new process or technology they have successfully implemented, whilst often applying problem solving skills, navigating challenges and learning from mistakes.
Whether it be the use of data analytics, technologies or automating processes, these implementations help to achieve manufacturing excellence.
These thought-provoking case studies provide an opportunity for contextual learning from others, whom we guarantee you’ll want to talk further with during the afternoon break immediately following the session.

  • Craig Stephens (Senior Director Quality of CSL Behring (Australia) Pty Ltd)

    Craig Stephens

    Senior Director Quality of CSL Behring (Australia) Pty Ltd
Case Study 3 • Using Power BI for Data & Metrics Visualisation
Tanvi Maturi

Do you find yourself with the laborious task of creating the same report week after week, month after month?  Rather than traditionally relying on external IT resources to create intricate automated reports, Microsoft Power Platform is an easy and intuitive tool that can be used by anyone who is experienced in standard Microsoft tools (particularly Excel). This is what is currently in use at CSL Behring, Broadmeadows. This presentation will cover how Power BI and the Microsoft Suite of tools can work together to easily transform raw data into actionable insights that the most basic users can navigate. Microsoft Power BI data flows can be used to share datasets with efficiency and without IT expertise, and allow us to gain control of reporting metrics by creating “One Source of truth” within large scale Pharmaceutical Enterprises.

  • Tanvi Maturi (CSL Behring)

    Tanvi Maturi

    CSL Behring
Case Study 4
Case Study 5
Panel Discussion and Q&A
Tanvi Maturi
  • Tanvi Maturi (CSL Behring)

    Tanvi Maturi

    CSL Behring
Coffee Break
Session 10 • Insights 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.