GMP Forum 2022
Selected Presentations from 2022 PharmOut 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
