A Better Pharmaceutical Manufacturing Industry by Design – the GMP, Engineering and Medicinal Cannabis Forum.
- Selected GMP, Engineering and Medicinal Cannabis presentations from the 2018 National Forum are available to download because the spirit of the event was to share the information.
- Beginning in 2011 as the National Validation Forum, this started out as not-for-profit event.
- It has been facilitated by PharmOut and supported by the TGA (for the first two years) and most importantly, supported by local businesses and medical cannabis industry experts in Cannabis industry production and manufacturing.
Selected Presentations
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
- Welcome, Trevor Schoerie, Managing Director, PharmOut
- Collaborative Robotics and Industry 4.0, Sean Ryan, Head of Sales and Consulting ANZ, Swisslog
- Australian Medicinal Cannabis, Trevor Schoerie, Managing Director PharmOut
- BioPhorum Technology Roadmap, Bob Lenich, Life Sciences Marketing Director, Emerson
- PIC/S PE009-13 Highlights of Changes, The Path Ahead, Maria Mylonas, PharmOut
Track 1 Presentations
- Changes to Annex 11 and GAMP, Seamus Orr, Lead Consultant, PharmOut
- Addressing the Gap, Some Practical Tips, Jeney Isbel, Site Quality Director, Pfizer
- A View from the Trenches, Evolving Quality Systems in a Contract Manufacturer of Listed Medicines, David Doolan. General Manager, Quest Pharma
Track 2 Presentations
- Draft Annex 1 – Part 1 – The Good, The Bad & The Ugly, Ashley Isbel, Lead Consultant, PharmOut
- PDA Feedback Innovation in Pharma, Eoin Hanley, Quality Assurance Compliance Projects Manager, CSL Behring
- Draft Annex 1 – Part 2 – Predictions for the Path Forward, Ashley Isbel, Lead Consultant, PharmOut
- Next-Generation Sequencing for Microbiological Identification, Wayne McKenzie, Director, Tara Cassidy, Microbial Diversity Specialist, Microgenetix
- Technological and Engineering Innovations around Sterile Medicinal Product Filtration, Michael Payne, Biosafety Technical Consultant, Merck
Track 3 Presentations
- Digital Transformations, Bob Lenich, Life Sciences Business Director, Emerson Automation Solutions
- Digital Transformation of your Plant Assets – Process Automation of our Virtual Pharma Plant, Ryan Orbell, Burkert
Track 4 Presentations
- Strain Selection – Which Strain is Best for you Considering Growth Habits, Disease Pest Resistance, Yields, and Composition
- Preserving strains – Traditional Cloning, Micro Propagation and Strategies for the future, Mica Gross, President, Master Grower, Sante Botanica, COO MDbioLogics
Day 2
Track 1 Presentations
- Quality and Production Relationship Building, Keith Johnson, Grunbiotics
- Taking a GMP PQS from Research to Manufacturing, Debbie Parker, Head of Quality, Vaxaas
- Clinical Supply and Sponsor Responsibilty, Yaara Dromi, Consultant, PharmOut
- How Professional Placements and Internships can work for you, John McPhee, Swinburne University
- Statistics for Process Validation Tutorial, Bass Masri, Principal Consultant, Statistical Techniques, Minitab
- Balanced Scorecards, QikSolve Learnings in a Quality Focused Industry, Matt Schoerie, Senior Consulant, Qiksolve
- Pharmacovigilance, Tanja Varglien, Lead Consultant, PharmOut
Track 2 Presentations
- Contamination Control Strategy, an overview, Ashley Isbel. Lead Consultant, PharmOut
- Risk Based Environmental Monitoring, Tanja Varglien, Lead Consultant, PharmOut
- New and Exisiting Cleanroom Facilities – What’s the Impact of Draft Annex 1, Ashley Isbel, Lead Consultant, PharmOut
- Regulatory Trends in Manufacturing of Sterile Medicinal Products by Filtration, Michael Payne, Biosafety Technical Consultant, Merck
Track 3 Presentations
- Unifying Monitoring Systems – What FMS OPC UA can do for your facility, Bradley Thomas, Applications Engineer, Kenelec
- Plug and Play Facility Access & Door Control, Keith Wilson, Sales Manager, ANZ, Critical Scientific Solutions
- Isolator Procurement for Small to Medium Enterprises, Charles Ross, Head of Clinical Operations & Supply, Vaxxas
- Driving your Industry 4ward, Jason Mair, Product & Marketing Manager, SICK Pty Ltd
- Trends in Stainless Steel Materials & Applications, Barry Gascoigne, Business Development Manager, Prochem Pipeline Products
- Solutions in Applying GMP for Complementary Medicines Manufacture, William Smillie, Senior Consultant, PharmOut
Track 4 Presentations
- Outline of Australian ODC TGA Regulatory Framework, Maria Mylonas, Training Services Manager, PharmOut
- Security Challenges and Principals when Dealing with Medicinal Cannabis, Zohar Dromi, Director, Shield Corporate Security
- TGA GMP Cannabis Facility, Trevor Schoerie, Managing Director, PharmOut
- Medicinal Cannabis Dosage Forms in California, Mica Gross, President Master Grower, Sante Botanica