Selected Presentations from 2022 GMP Forum
Not all presentations from the forum are able to be shared. Below are those where permission has been granted by the speaker.
Day 1
Plenary Presentations
- Pharma 4.0, Internet of Things (IoT) – Trevor Schoerie
- The Who, What & Why of Microplastics – Dr Amy Heffernan, Regional Technical Specialist
- Vaccine + Vaccination = Pandemic Protection – a Vaxxas industry update – Charles Ross, Head of Clinical Operations
- The Covid-19 pandemic and response, how TGA responded to Covid-19 with testing, PPE and new medicines and vaccines – Adrian Bootes, CR Consult Pty Ltd, Principal and Director
Pharma 4.0
- The Journey to a Paperless Facility and Augmented Reality – Sharon Orr, Manager, Innovation and Technical Operations CSL Innovation
- How Industry 4.0 is Critical to the Success of ATMP’s – Bindhu Radhakrishnan Snr. IT Compliance Specialist
- Pipeline Acceleration by Digital Tech Transfer & Real Time Production Planning – Makarand Mujumdar, Sr. Sales Engineer- Systems & Software, Emerson
- AstraZeneca Digitalization Journey and Adoption of Quality 4.0 – Seamus Orr, Technical Services Manager, AstraZeneca
- Pharma 4.0 AI in Pharmaceutical Manufacturing – Susan Cheong, Senior Consultant, PharmOut
Facility, Services and Equipment
- Innovative Facility Options in an Era of Urgent Capacity Needs – Peter Makowenskyj, Director of Design Consulting, G-CON Manufacturing
- Developments in Continuous Monitoring – Shaun Raebel, Sales Engineer – Continuous Monitoring Systems, Contamination Control & Critical Environments, Kenelec Scientific Pty Ltd
- Sustainability in the Life Sciences Industry – Nic van der Nol, Architecture and Engineering Services Director, PharmOut
- EMS Project Development and Implementation – Ivan Woo, Environmental Particle Monitoring System Sales Engineer, Laftech
Pandemic Related
- Covid-19 Vaccine a Distributor’s Experience – Sarah Ballantyne, Quality Systems Manager, Linfox Healthcare Logistics
- Manufacturing Systems for Vaccines and Biopharmaceuticals – John Power, Group Leader, Regulated Biomanufacturing, CSIRO Biomedical Manufacturing
- Modern Methods for Microbial QC – Tara Cassidy, NGS Account Manager, Charles Rivers Laboratories
Day 2
Compliance
- 25 years of setting the gold standard for GMP accredited chemical testing – Richard Miller, Laboratory Services Manager, Chemika
- Maintaining and Promoting Quality Culture – Ahsan Syed Ali, Director of Quality and CMC Regulatory, QBiotics Group Limited
- The Crossroads of Compliance, Audit Readiness, Profitability, and Data Integrity – Makarand (Mak) Mujumdar, Sr. Sales Engineer, Systems & Software, South East Australia, Emerson Automation Solutions
- New Regulations – Annex 2A & 2B – ATMPs and Biological Medicinal Substances – Ashley Isbel, GMP Services Director, PharmOut
- Annex 16 (Authorised person and batch release) – Tina Christensen-Ram, Snr. Consultant, PharmOut
- Remote Auditing – How to be successful from behind a webcam – Maria Mylonas, Learning and Development Director, PharmOut
- Decentralized Clinical Trials in APAC – An emerging Market – Rima Darwiche
- TGA recently released “Good Clinical Practice (GCP) inspection program” – Silvana Sekuloski, Senior Consultant, PharmOut
- Challenging Times for Quality, Technical or Validation Managers how to stay sane – Robert Caunce, Technical Manager, Baxter Laboratories
Facility, Services and Equipment
- Embracing Digital Technology to improve your operational goals – Ryan Orbell, National Industry Manager – Pharmaceutical & Biotechnology, Burkert Fluid Control Systems
- Implementing a Manufacturing Execution System (MES) project – John Nesbitt, Director, Wayahead Systems
- Challenges in Vaccine Manufacturing & Scale-up – Jacob MacDonald, Project Manager/Vertical Lead Pharma Digital Industries (Pharmaceuticals), Siemens
- Measuring Technology for the Pharmaceutical Industry – Dinesh Kumar, Market Manager – Business Unit Solutions, Anton Paar
- An Australian Vaccine Development and Manufacturing Hub for mRNA, DNA and Recombinant Vaccines – Ganeshan Varnakulasingham, CEO, Sypharma Pty Ltd
- Containment glove technology – Sylvio Pasqualini, Asia Pacific & Europe Manager PIERCAN
- Greenfield vs Brownfield facilities: Pharmaceutical Facility – Top Tips – Nic van der Nol, Architecture and Engineering Services Director, PharmOut
- Case study. Making the leap: From Compounding to GMP Contract Manufacturing – Faiz Ferdosian, Director, Artisan Chemist / Artisan Labs
Sterile Manufacturing
- Update on the revision of Annex 1 – Sterile Medicinal Products – Ashley Isbel, GMP Services Director, PharmOut
- Annex 1 and Continuous Microbial Air Monitoring – Glenn Manning, Application Specialist, Sartorius
- Sterile Medicines – Visual Inspection Considerations – Shane Bourne, Lead Consultant, PharmOut
- Cleaning Validation: Is your analytical method fit for purpose? – Alan Doughty, Managing Director / Chief Chemist, Chemika
- Preparing a Contamination Control Strategy for the draft Annex 1 Compliance – Ashley Isbel, GMP Services Director, PharmOut
- Latest innovation in Freeze Drying for R&D and Production – Andreas Vihs, Sales Manager, Martin Christ
- How Operational Excellence can Support Innovation and Growth – Annette Grundy, Head of Operational Excellence (PPI) Pharma Services, Thermo Fisher Scientific
- Data Loggers & Thermocouples – Ellab all-in-one Solutions for Qualification, Validation, Monitoring and Batch Control – Roman Loretts, Senior Sales Manager – Indirect Channel Ellab A/S, Denmark