Selected Presentations from the PharmOut GMP Forum 2023
Not all presentations from the GMP Forum 2023 are able to be shared. Below are those where permission has been granted by the speaker.
Day 1
Plenary
- Opening the Forum – Trevor Schoerie, Managing Director, PharmOut
- Critical Times Demand Critical Thinking – Jason Clarke Founder Minds at Work
- Reliable and Sustainable Bacterial Endotoxin Testing with Recombinant Factor C (rFC) – Wojciech Sleczek Pharma Quality Control, ASPAC, Business Development Manager, bioMérieux
- GCP for GMP Professionals – Kylie Sproston, Chief Executive Officer, Bellberry Limited
- Global Health and Epidemics of Poverty in a COVID-19 World – Negaya Chorley, CEO, RESULTS International (Australia)
Tracks 1,2,3
- Australian PV requirements – Carl Bufe, Director of Pharmacovigilance, PharmOut
- Contamination Control Strategy – Ashley Isbel, GMP Services Director, PharmOut
- Annex 1 – Focus on Filter Integrity Testing and PUPSIT – Micheal Schafferius, Application Specialist, Sartorius
- Smoke Visualization Studies – Seamus Orr, Technical Services Manager, AstraZeneca
- Data Integrity & Analytical Instrument Qualification – Leveraging on Supplier’s Capabilities – Sheng Sheng Su, Anton Paar
- Protecting and Defending your Intellectual Property – Mitchell Zadow, Managing Principal & Accredited Specialist (Commercial Law), Sharrock Pitman Legal | Caroline Callegari, Special Counsel, Sharrock Pitman Legal
- Real time Microbial Monitoring Progress – BioTrak – Shaun Raebel, Sales Engineer, Continuous Monitoring Systems, Contamination Control & Critical Environments, Kenelec Scientific
- Facility Design Case Study – Nic van der Nol, Director Architecture & Engineering Services, PharmOut | Faiz Ferdosian, Managing Director, Artisan Chemist
- IT / OT Megatrends in a Pharma4.0 World – Trevor Schoerie, Managing Director, PharmOut
- Review of current Australian and ISO Standards that have recently been published, and are currently under review – Paul Morgan, Critical Scientific Solutions
- Registration of Medicines – Natalie Allen, Director of Regulatory Services, PharmOut
Day 2
Tracks 1,2,3
- AI/ML Empowered Pharma4.0 Use Cases – Jonathan Krieger, Solutions Consultant Industrial Software, Emerson
- HPLC with Post Column Derivatisation: Is there any need to Panic? – Andrew Jones, Analytical Development Manager, Chemika
- Utilising Modern Methods for your Contamination Control Strategy – Tara Cassidy, NGS Account Manager, Charles River Laboratories
- Quality in Emerging Oral Therapies – Priscilla Thiyageas, Director of Quality, IDT Australia
- Operational Excellence in a Low Bioburden Biotechnology Facility – Annette Grundy, Head of Operational Excellence (PPI) Pharma Services, Thermo Fisher Scientific
- “Bringing Order to Data” in Life Sciences – Makarand (Mak) Mujumdar, Industry Specialist – Life Sciences, Australia & New Zealand, Emerson Automation Solutions
- ICHQ9 (R1) Updates – Maria Mylonas, Business Development Director, PharmOut
- Sustainability in the Cleanroom World – Shaun Raebel, Sales Engineer, Continuous Monitoring Systems, Contamination Control & Critical Environments, Kenelec Scientific
- Can Virtual Reality training have a role in GMP? – Gerry McKiernan, Director Of Quality, Cell Therapies | Jonathan Bannister, Managing Director, The Design Technology Company
- An Introduction to Clinical Trials for Pharma Professionals – Silvana Sekuloski, Lead Consultant, PharmOut
- Tulip Applications in GMP Manufacturing – Luke Armstrong, Product Quality Advisor, AstraZeneca Australia
- Continuous Improvement – How to Prove Effective Implementation – Tina Christensen-Ram, Product, Snr. Consultant, PharmOut
- Bioprocessing: Saving Lives, Feeding the World – Imko Gaastra, Area Manager Project Sales, Getinge
- We All Know What GMP is an Acronym for, or do we? – Robert Caunce, Technical Manager, Baxter Laboratories
- Selecting Software Vendors for Successful Relationships – Matthew Schoerie, QikSolve
- Tips and Tools for a Successful Root Cause Analysis (RCA) and Investigation – Mir Ali, Quality Manager, Rationale Cosmetics
- Good Distribution Practice (GDP)/ Good Warehousing Practice (GWP) – Insights into Local vs Global expectations – Sarah Ballantyne, Quality Systems Manager, Linfox Healthcare Logistics
- Stage 3 Validation – Ongoing Process Verification – Ashley Isbel, GMP Services Director, PharmOut
- A Practical Crash Course in Risk Assessments – Shane Bourne, Lead Consultant, PharmOut | Susan Cheong, Senior Consultant, PharmOut
- ICH Q13 Continuous Manufacturing of Drugs Substances and Products and Flow Chemistry – Trevor Schoerie, Managing Director, PharmOut
- The Good, the Bad and the Findings – Inspection Deficiencies and Trends – Maria Mylonas, Business Development Director, PharmOut