2025 GMP Forum Presentations & Highlights

Pharma & Device Forum – Education Sessions

On the 31st of March and 1st of April 2025, ~ 250 life science professionals, including those from the pharmaceutical industry, laboratory sciences/research sectors, quality management, operations management, and medical devices sectors, came together in Melbourne for the 14th ‘GMP Forum’ (the 2025 Pharma & Device Forum organised by PharmOut).

Overview of educational & professional development presentations.

• Over 47 renowned industry experts shared their knowledge and perspectives on the future of the life sciences industry at the 2025 Pharma & Device Forum.
• Each presentation offered valuable insights into emerging technologies, regulatory developments, innovative operational strategies, and advances in sustainable manufacturing and laboratory science.
• Attendees and speakers from more than eight countries – including Australia, France, Italy, New Zealand, Pakistan, Singapore, the United Kingdom, and the United States – contributed to the event’s truly global perspective.

• Other presentations included management of deviations and conducting adequate root cause investigations (RCAs) as part of CAPAs, FDA Form 483 observations (global trends), sterile manufacturing success, sterile manufacturing ‘on steroids’, applying AI and LLM/ML technology to improve quality management systems, ICN Victoria’s support frameworks for Medical Manufacturers, BSL-3 Airborne Surface Disinfection Strategies, Regulatory Compliance in a Digital World, and so much more!
• Click the button below for the full agenda (Attendees and Speakers can consult their Eventify app until the 12th of April 2025).

Life sciences services, laboratory sciences, radiopharmaceuticals, & cleanroom equipment Sponsors

This year’s Forum would not have been possible without the support of 20 key industry partners, including our Platinum Sponsor, bioMerieux, and our many other inspiring Sponsors.

Capacity Building & Professional Development for Life Sciences

• We were fortunate to have emcee Brett de Hoedt chair the Plenary Session.
• He asked thought-provoking questions of the Plenary presenters and helped international arrivals understand the nuances of Melbourne’s culture.
• We were also grateful for the support of the City of Melbourne; Councilor Andrew Rowse welcomed guests and shared how the City is actively supporting the life sciences and medical manufacturing industries.
• It was an honour to hear from Professor Greg Hunt, Fiona Smith, Siôn Wyn, Megha Bajaj, and Luke Armstrong as our Plenary speakers on Day 1, and other industry experts who generously volunteered their time and knowledge to help strengthen the life sciences sector and support the growth of its professionals.

The Professor (The Hon) Greg Hunt (University of Melbourne and Connected Workplaces)

“The Future of Healthcare: Global Megatrends & Australian Opportunities,” presented by Professor (The Hon) Greg Hunt during the Plenary Session, explored global healthcare mega-trends and Australian opportunities. Greg highlighted advances in genomics, stem cells, precision health, remote care, and rising national health spending projections. He also outlined key programs like the Medical Research Future Fund and National Reconstruction Fund, which support innovations in diagnostics, therapies, and medical manufacturing. The presentation closed with leadership lessons from the pandemic and a forward-looking vision for patient-centric healthcare systems and new medicines.

Fiona Smith (CSL Seqirus)

Industry luminary Fiona Smith (CSL Seqirus) provided an update regarding a Sovereign Capability Facility (Banksia) in Victoria. Fiona shared her extensive pharmaceutical industry expertise along with valuable insights from major infrastructure projects. Fiona Smith is the Senior Director (Quality) for Project Banksia in Victoria, a $1 billion Greenfield Pharmaceutical Manufacturing Facility that will produce cell culture influenza vaccines and products of national significance, including anti-venoms.

Siôn Wyn (Conformity Ltd) 

The legendary Siôn Wyn, editor of several GAMP®5 publications and a renowned consultant and trainer on regulatory compliance topics, shared his expertise on computerised system validation (CSV), Annex 11 compliance, and GAMP®5, Second Edition. Siôn shared valuable insights into regulatory compliance inspection observations relating to validation strategies, data integrity governance, and more. This was followed by another session on GAMP®5 (2nd Ed) standards & FDA Computer Software Assurance (CSA) on Day 2 of the Forum, plus an intensive CSV training workshop the day after the Forum.

Luke Armstrong (AstraZeneca)

International quality systems expert & quality leader Luke Armstrong shared his insights into how artificial intelligence and machine learning are reshaping the life science industry. Luke Armstrong presented fascinating case studies on the practical applications of artificial intelligence (AI, LLM & ML) and digital tools in pharmaceutical manufacturing, with a focus on Tulip applications. His session highlighted how these AI technologies, while still evolving, are already capable of improving business workflows, supporting sustainability goals, reducing costs, and maintaining high-quality outcomes. Luke encouraged attendees to consider how they might begin implementing such tools in their own operations, emphasizing that the time to start is now.

Megha Bajaj (bioMérieux) 

Megha Bajaj, Global Solutions Manager, Industrial Applications, presented “Enhancing Pharmaceutical QC with Ready-To-Use Microorganisms” (bioMérieux). Megha’s presentation delved into aseptic processing, sterile manufacturing, plant isolates, detecting various microorganisms, and recent trends in FDA Form 483 observations relating to microorganism detection methods. Megha shed light on common microbiology testing challenges, such as inoculum variability and strain management. Megha shared practical solutions and valuable insights, making it an informative and engaging session. Her company (bioMérieux), the Platinum Sponsor, also sponsored the networking session held that evening, and the life science community is grateful for their ongoing support of professional development for the industry.

For photos, follow @bioMerieux and @PharmOut on LinkedIn.

Bob Tribe (Bob Tribe Consulting)

A world-renowned expert in the regulatory compliance sectors is Bob Tribe, a high-level Consultant to GMP Regulatory Authorities around the globe. With over three decades of regulatory compliance experience, Bob Tribe is regarded as a true expert in the field. As Chief GMP Auditor at the Australian TGA for 23 years, Bob had a hand in creating many of the GMP requirements now in place. He continues to consult for many GMP regulators around the world, assisting them in reaching the PIC/S level of regulatory control.*

Bob presented a brilliant talk on “The Pan Pharmaceuticals’ Crisis of 2003: Lessons we may have forgotten,” covering the nuances of a series of events leading to one of the greatest product recalls in Australia. A brilliant presentation of the key elements of a crisis, and a stark reminder of Winston Churchill’s words” Never let a good crisis go to waste”.

*Bob Tribe has assisted the Health authorities of South Africa, Israel, Cyprus, Ukraine, Indonesia, Taiwan, South Korea, Hong Kong, Japan, Thailand, Turkey, Iran and Saudi Arabia in obtaining PIC/S membership. He is currently assisting the regulatory authorities of Russia, Jordan, Pakistan, Philippines, Azerbaijan & Ethiopia attain PIC/S membership.

Kathy Walsh (Quality Systems Now)

Quality & regulatory compliance advocate Kathy Walsh’s presentation, “Influencing Top Management for Compliance – How to Talk to Senior Leaders and Get Results”, was a popular topic for quality management professionals, authorised persons, and GMP consultants. Her presentation highlighted the importance of clearly communicating real-world evidence to support investment in quality system improvements and the necessity of ensuring a GMP-compliant culture across the entire organisation.

Dave Nobile (Contec)

Dave Nobile, Technical Services Manager at Contec, presented “Characteristics and Challenges of Disinfectant Residues on Environmental Surfaces”. In a popular GMP Forum presentation on contamination control/decontamination, Dave discussed residue characteristics and challenges, effective residue removal methods, and ongoing residue management. Dave’s presentation covered process-related residues (process and equipment ) as well as residue from raw materials, products, buffers, media and excipients. He also shared his expertise on the detection and removal of environmental chemical residues from detergents and disinfectants. We truly appreciated that Dave flew in from the United States to share his expertise with the Forum audience.

Dr Garima Sharma (Medicines Manufacturing Innovation Centre – MMIC, Monash University)

Dr Garima Sharma (Senior Scientist & Business Development associate) presented “Therapeutic product development with the goal of being GMP ready”. Dr Garima presented important insights and practical tools for life science professionals, Universities, biotech companies and investors involved with product design, clinical research, product formulations, drug development, laboratory testing, manufacturing scaleups, workforce development and other aspects of production and commercialization of new medicinal products.  She also discussed terminal sterilisation and sterile filtration techniques, and gave an insightful overview of how MMIC can support therapeutic development projects. Note: The MMIC is a Therapeutic Innovation Australia facility and part of the TIA Pipeline Accelerator voucher program. The scheme was introduced to reduce the cost of access to specific capabilities for therapeutic development projects. It is a competitive scheme that provides up to $50,000 with at least 50% matching funding (co-investment) by Australian-based applicants.

Anne Saletti-Hayes (PharmOut) 

Anne Saletti-Hayes (Senior Consultant, Regulatory Services ) presented “Medical Device Regulations on the Move: What’s Changing & How to Adapt.” Anne’s presentation explored recent medical device regulatory changes across the EU, US, and Australia. Anne’s presentation included practical strategies to monitor, interpret, and adapt to shifting regulatory requirements. By sharing her expertise on using regulatory intelligence as a proactive tool, she helped medical device manufacturers better anticipate changes and strengthen their ability to meet evolving requirements.

John Montalto (Apex JM Consulting) 

John Montalto, Life Sciences Quality Management Systems and Compliance Leader/Consultant, shared health tech and AI/digital innovations relevant to the “Remote Healthcare Revolution.” He explored how emerging health technologies and healthcare delivery systems must focus on being patient-centric, especially in an aging, increasingly diverse, and rural population. His presentation highlighted some of the latest health tech innovations, with impressive insights into what these new technologies and medical devices can provide (outside of a hospital setting) in terms of patient care and health monitoring. A key takeaway of John’s presentation was the importance of ensuring a connected and collaborative approach — where healthcare professionals, the broader care community, and medical devices work together — to overcome key healthcare industry issues such as data security and limited resources.

Tom Stray (DentaLife Australia)

Tom Stray, Managing Director at Dentalife, presented “Medical Device Manufacturing in Australia”. He shared his extensive manufacturing expertise and case studies, including product design & development and manufacturing scale-up experiences. He presented an intriguing case study of manufacturing and scaling-up medical device manufacturing as the only Class IIb Instrument Grade Disinfectant Manufacturer in Australia. Tom Stray was a former Professional Cricketer for South Australia and Victoria.

Helen Evans-Lemmo (Ego Pharmaceuticals) 

Helen Evans-Lemmo, an Instrumentation Specialist and Sustainability Strategist, presented “Laboratory Business Sustainability: Ensuring Compliance and Customer Confidence through Automation.” Helen illustrated how automation is reshaping in-house pharmaceutical laboratories while boosting compliance, improving efficiency, and reducing environmental impact. She shared practical insights from Ego Pharmaceuticals’ sustainability journey. She shared compelling case studies showing how automated sample preparation improved operational efficiency, reduced costs, and supported global sustainability goals – all while maintaining customer trust in a constantly evolving regulatory environment.

Sandra Dal Maso (Australian Packaging Covenant Organisation – APCO) 

Sandra Dal Maso, Head of Packaging Transformation at APCO, spoke about Australia’s co-regulatory packaging model, national packaging targets, and the challenges in achieving them. She outlined APCO’s 2030 strategy, which calls for stronger regulation, national consistency, and greater industry collaboration in response to increasing pressure from consumers, government, and regulators. Sandra highlighted the growing scrutiny around greenwashing and shared key points from a Department of Climate Change, Energy, Environment and Water consultation paper, which proposes three reform options: enhanced co-regulation, direct regulation, and a nationally regulated extended producer responsibility (EPR) scheme. A key message was that “despite brand owners’ efforts to improve packaging recyclability, major barriers remain – including infrastructure gaps, limited markets for some materials, and ongoing consumer confusion. APCO’s 2030 strategy aims to help close these economic and systemic gaps.”

Micheal Schafferius (Sartorius)

Micheal Schafferius (  title) presented “Forever Chemicals – Imagine Not Being Able to Use PVDF tomorrow” as part of the educational segment covering sustainable manufacturing initiatives for medicines & medical devices. Micheal’s presentation sparked very interesting and timely discussions about environmental sustainability and impending changes to the sector in terms of manufacturing and delivering pharmaceuticals, medical devices, and combined products. Sustainability, substances, and material changes are definitely front of mind in the industry, and we were truly grateful to Micheal for sharing his insights on how organisations can prepare for the significant changes ahead across various areas of manufacturing.

Excerpt: “PFAS polymers are used in various processing equipment in the (Bio) Pharma industry, such as seals, tubes, and filters, due to their unique chemical properties, making alternatives scarce. Despite their current legal use in the industry, PFAS is under regulatory scrutiny, with global efforts to restrict their use, including the European Union’s REACH restriction proposal and the US EPA’s regulations on drinking water. Various regions have differing regulatory approaches, with Australia focusing on contamination investigation and PFAS use regulation, while the EU and US are progressing with stricter legislation.

Micheal highlighted that Sartorius is addressing these concerns by launching a PFAS-free filter product, “Sartopore Evo,” in 2025, aimed at liquid filtration in final filling applications. Sartorius is proactively analyzing its product portfolio and developing PFAS-free alternatives to ensure regulatory compliance, sustainability, and secure supply chains in the face of increasing societal pressure to phase out PFAS.

 Paul Wynne (Gelteg)

Paul Wynne, Chief Scientific Officer at Gelteg, presented “Crossing the Rubicon: What to do when oral dose minimisation is no longer effective”.  Paul’s presentation focused on the design and implementation of novel oral dose forms, exploring how Gelteq has approached oral dosage forms from a different angle for the nutritional and pharmaceutical sectors.  Instead of minimising dose size, they use a gel vehicle to manage larger dose sizes in a way that is manageable across populations that struggle with swallowing, including paediatric and dysphagic groups. The gel also assists with taste moderation, protects active substances from acidic degradation, and provides an alternative approach to dispersion of lipid soluble drugs.

Excerpt from LinkedIn (Paul Wynne): “It is easy to be passionate about the Gelteq formulation approach for its impact on the dysphagia and large dose sectors, but I was delighted to go further in talking about longitudinal distribution of lipid-based and poorly soluble systems.” A very intriguing topic and presentation indeed!

Kara O’Connor (AstraZeneca)

Kara O’Connor, Aseptic Validation Specialist at AstraZeneca, presented: “Sterile Success: Achieving Compliance and Efficiency in Aseptic Process Simulations“. Covering popular topics relevant to sterile manufacturing, Kara’s presentation delved into the latest advances in Quality by Design (QbD) and regulatory compliance expectations for aseptic production processes. Kara’s presentation highlighted the limitations of batch sterility testing in the detection of low-level batch contamination necessitates. She shared useful information regarding aseptic process simulations, common audit observations and solutions, and strategies for periodic validation of aseptic production processes.

Mr. Alan Hoffmeister (Charles River, Microbial Solutions Division)

Bacterial Endotoxin Testing Subject Matter Expert Alan Hoffmeister (attending from the UK via Ireland) is the Senior Global Scientific Portfolio Specialist for Charles River, Microbial Solutions Division. Alan presented “Adopting USP Chapter <86>: Efficiently Transitioning to Recombinant Endotoxin Testing.” This session provided an overview of USP <86> and the validation of recombinant Chromogenic Reagent (rCR) methods for bacterial endotoxin testing (BET). Alan provided insights into the performance parameters required to validate a BET method using recombinant reagents, the endpoint fluorescence method and the chromogenic method, and differences in global regulatory expectations.

The official publication of Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents, marks a significant milestone in bacterial endotoxin testing, incorporating recombinant reagents as an accepted method, and prompts critical questions for laboratories, concerning updates necessary to existing procedures and whether current legacy systems continue. For labs planning to adopt these recombinant methods, understanding the pathway for a seamless transition is vital and this presentation set out the implications of Chapter <86> on current practices, gave a comparative analysis of USP <86> and international regulations to align global compliance strategies, and detailed step-by-step recommendations for adopting recombinant methods. [Mr. Alan Hoffmeister, Endotoxin Testing Subject Matter Expert]

Charlotte Gourraud (Devea Environment)

Charlotte Gourraud, Co-Managing Partner at Devea Environnement (Devea Environment) flew in from Nantes, France, and presented “BSL-3 Airborne Surface Disinfection strategy: Selection of a new provider for safe and efficient disinfection, cycle development and performance qualification with spores and viruses“. Charlotte’s presentation delved into Annex 1 recommendations for aseptic systems design (ASD), Risk Analysis and Quality Risk Management (QRM). Her case study highlighted Control Strategy (CCS) frameworks and how manufacturers must evaluate, justify, and validate their contamination‑prevention methods and target values. Charlotte discussed bio‑decontamination, decontamination, disinfection strategies, isolators, biosafety cabinets, airlocks, and barrier technologies, particularly Restricted Access Barrier Systems (RABS) and isolators. She closed her session with a reminder of the regulatory obligation to validate the efficacy of all disinfection procedures.

Bhargav Mehta (AstraZeneca)

Bhargav Mehta, Validation Specialist at AstraZeneca, presented “Sterilization on Steroids”, a very popular presentation title and important sterile manufacturing topic! Bhargav’s presentation delved into process parameters, extruder sterilization processes & extruder challenge tests, and how to conduct the calculation of log reduction. Bhargav shared important insights relevant to bracketing, duration of holds, scheduling, and routine process confirmations. Bhargav also shared his expertise in reducing environmental risks at the execution of the Extruder Challenge Test. It was a highly informative session offering many valuable insights!

Dr Lee Yong Jian, PhD (Charles River, Singapore)

Dr Lee Yong Jian (Technical Services Manager, Microbial Solutions, Charles River Singapore) presented “A GMP-compliant approach to in-process contamination control and sterility release testing using Celsis ® Rapid Microbial Detection platform.” Dr Lee discussed rapid sterility testing and the early identification of potential sources of contamination, a topic especially pertinent to short shelf-life products including cell therapies, gene therapies, radiopharmaceuticals, and clinical trial products. Dr Lee shared the advantages of Rapid Microbiological Methods (RMMs) as part of the contamination control strategy (CCS) and the global implementation of the Celsis® ATP-bioluminescence system, using an validation approach in accordance to USP <1223>, Ph. Eur. 5.1.6, and PDA TR33. Another great presentation on contamination control, microbial detection strategies, and product testing technologies.

Dr Michael Wheatcroft (Telix), Dr John Young, and Nic van der Nol (PharmOut)

The radiopharmaceutical manufacturing presentations were extremely popular life science education sessions.

Dr John Young and Nic Van Der Nol (PharmOut) delved into the background of radiopharmaceuticals and their pivotal role in modern medicine.

Dr. Michael Wheatcroft from Telix Pharma shared how Australian biotech led the resurgence of radiopharmaceuticals, driving innovation and growth across the sector.

Nic Van Der Nol discussed cutting-edge radiopharmaceutical manufacturing facility designs, highlighting strategies to ensure efficiency and compliance in this rapidly evolving field.

CSV experts Sion Wyn, Seamus Orr, Maureen Tay, and Trevor Schoerie

Day 2 ended with a Panel discussion with computer system validation experts Sion Wyn, Seamus Orr, Maureen Tay, and Trevor Schoerie.

View the presentation slides

The professional development and education sessions listed above are just some of the 47 expert presentations delivered during the 2025 Pharma & Device Forum (2025 GMP Forum).

To review the PDFs of some of these presentations, visit: https://www.pharmout.net/pharma-device-forum-2025-presentations/

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