GMP & Engineering Forum 2018 Schedule
The GMP & Engineering Forum 2018 will be held on 06 / 07 August 2018 at the Pullman on the Park, Melbourne.
Like 2017 it will have a plenary session on the first morning, followed by 4 educational tracks. The speakers and topics will be updated regularly as the spots are filled, please check back for the latest additions.
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Plenary Session” font_container=”tag:h2|font_size:50|text_align:left” use_theme_fonts=”yes”][clear by=”15px” id=”” class=””]
| 9:00 - 9:05 | Trevor Schoerie, Managing Director PharmOut Welcome |
| 9:05 - 9:45 | Charles Ross, Head of Clinical Operations & Supply, Vaxxas Revolutionising Vaccination |
| 9:45 - 10:30 | Sean Ryan, Head of Sales and Consulting ANZ, Swisslog Collaborative Robotics and Industry 4.0 |
| 10:30 - 11:00 | Tea/Coffee |
| 11:00 - 11:30 | Trevor Schoerie, Managing Director PharmOut, Australian Medicinal Cannabis |
| 11:30 - 12:00 | Bob Lenich, Life Sciences Business Director, Emerson Automation Solutions BioPhorum Technology Roadmap |
| 12:00 - 12:30 | Maria Mylonas, Training Services Manager, PharmOut PIC/S PE009-13 Highlights of Changes & The Path Ahead |
| 12:30 - 13:30 | Lunch |
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Main Sessions” font_container=”tag:h2|font_size:50|text_align:left” use_theme_fonts=”yes”][clear by=”15px” id=”” class=””]
| TRACK 1 GMP Compliance and Validation General Manufacturing | TRACK 2 GMP Compliance and Validation Sterile & Aseptic Manufacturing | TRACK 3 Facility Design & Equipment | TRACK 4 Medicinal Cannabis | |
|---|---|---|---|---|
| Changes in Regulations | New Sterile Guidance | Innovative Technology | Medicinal Cannabis | |
| 13:30 - 14:00 | Seamus Orr, Lead Consultant, PharmOut Changes to Annex 11 and GAMP | Ashley Isbel, Lead Consultant, PharmOut Draft Annex 1 - Part 1 (The Good, The Bad & The Ugly) | Bob Lenich, Life Sciences Business Director, Emerson Automation Solutions Digital Transformations | Professor German Spangenberg, Deputy Secretary, Agriculture Research, Department of Economic Development, Jobs, Transport and Resources Victorian Medicinal Cannabis Industry |
| 14:00 - 14:30 | Jeney Isbel - Site Quality Director, Pfizer Addressing the gap, some practical tips | Eoin Hanley - Quality Assurance Compliance Projects Manager, CSL Behring PDA Feedback: Innovation in Pharma | Lucas Bogtstra , General Manager, Testo Impact of Industry 4.0: Cold Chain Management | Andrew Exner, (Master Grower) Sante Botanica Strain Selection - which strain is best for you? Considering growth habits, disease/pest resistance, yields, and composition International speaker, US |
| 14:30 - 15:00 | Mark Dickson, Director of Quality Assurance, Compliance, CSL Behring Changes tAnnex 15 | Ashley Isbel, Lead Consultant, PharmOut Draft Annex 1 - Part 2 (Predictions for the Path Forward) | Ryan Orbell, National Segment Manager, Hygienic Processing, Burkert Fluid Control Systems Digital Transformation of your Plant Assets - Process Automation of our Virtual Pharma Plant. | Mike Hofmann, Canadian Cultivation expert Cultivation on scale International speaker, Canada |
| 15:00 - 15:30 | Tea/Coffee | Tea/Coffee | Tea/Coffee | Tea/Coffee |
| Evolving Quality | Emerging Microbiological Technologies | Logistics | Medicinal Cannabis | |
| 15:30 - 16:00 | David Doolan. General Manager, Quest Pharma A View from the Trenches, Evolving Quality Systems in a Contract Manufacturer of Listed Medicines’ | Wayne McKenzie, Director & Tara Cassidy, Microbial Diversity Specialist, Microgenetix Next Generation Sequencing for Microbiological Identification | Leigh Willis, Principal, LW Consulting Case Study - Lessons Learnt from New Facility & Utilities Installation (Mayne Pharma Adelaide) | Mica Gross, President (Master Grower) Sante Botanica/COO MDbioLogics
Preserving strains – Traditional Cloning, Micro Propagation and Strategies for the future International speaker, US |
| 16:00 - 16:30 | Dina El-Emary, Continuous Improvement and Compliance Manager, CSL Behring Quality Improvements | Michael Payne, Biosafety Technical Consultant, Merck Millipore Technological and Engineering Innovations around sterile medicinal product filtration | Nic van der Nol, Executive Architect, PharmOut Equipment & Facility Design Case Studies | Questions and Answers |
| 16:30 - late | Drinks Function | Drinks Function | Drinks Function | Drinks Function |
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Main Sessions” font_container=”tag:h2|font_size:50|text_align:left” use_theme_fonts=”yes”][clear by=”15px” id=”” class=””]
| TRACK 1 GMP Compliance and Validation General Manufacturing | TRACK 2 GMP Compliance and Validation Sterile & Aseptic Manufacturing | TRACK 3 Facility Design & Equipment | TRACK 4 Medicinal Cannabis | |
|---|---|---|---|---|
| Quality Culture | Contamination Control | Next Generation Facilities | Medicinal Cannabis | |
| 09:00 - 09:30 | Stoyan Atanasov, Senior QA Associate, CSL Behring Continuous Quality Improvement | Ashley Isbel. Lead Consultant, PharmOut Contamination Control Strategy, an overview | Nic van der Nol, Executive Architect, PharmOut Digital Twinning | Maria Mylonas, Training Services Manager, PharmOut Outline of Australian ODC / TGA regulatory framework |
| 09:30 - 10:00 | Keith Johnson, Production Manager, Grunbiotics Quality and Production Relationship Building | Tanja Varglien, Lead Consultant, PharmOut Risk Based Environmental Monitoring | Bradley Thomas, Applications Engineer, Kenelec Unifying monitoring systems – What FMS OPC UA can do for your facility | Zohar Dromi Security challenges and principals when dealing with medicinal cannabis International speaker, Israel |
| 10:00 - 10:30 | Maria Mylonas, Training Services Manager, PharmOut Fostering Quality Culture | Leah Rudd, Senior Associate, Quality Assurance Projects & Purush Devanathan, Qualification Lead, CSL Behring Considerations for qualifying a filling line isolotor | Barry Hendy, Managing Director, ADDE Dreams to Concept to Reality: A case study | Mike Hofmann, Canadian Cultivation expert Commercial scale cannabis considerations International speaker, Canadian |
| 10:30 - 11:00 | Tea/Coffee | Tea/Coffee | Tea/Coffee | Tea/Coffee |
| Case Studies | Sterile Manufacturing Hot Topics | Containment & Isolation | Medicinal Cannabis | |
| 11:00 - 11:30 | Debbie Parker - Head of Quality, Vaxxas Taking a GMP PQS from research to manufacturing | Ashley Isbel, Lead Consultant, PharmOut New & Exisiting cleanroom facilities - what's the impact of draft Annex 1? | Keith Wilson, Sales Manager, ANZ, Critical Scientific Solutions Plug and Play Facility Access & Door Control | John Van Der Wilk, Advanced Controls for Cannabis Greenhouse & Indoor Grows International speaker, EU |
| 11:30 - 12:00 | Yaara Dromi, Consultant, PharmOut Clinical Supply and Sponsor Responsibility | Michael Payne, Biosafety Technical Consultant, Merck Millipore Regulatory Trends in Manufacturing of Sterile Medicinal Products by Filtration | Trevor Schoerie, Managing Director, PharmOut Case Study - high potency containment | Tom Forrest, Co-Founder & Horticultural Specialist, Indicated Technology Lighting considerations |
| 12:00 - 12:30 | John McPhee, Associate Director – Engagement Development, Swinburne University - Work Integrated Learning How Professional Placements & Internships can work for you | Vicenc Garcia, Astra Zeneca Real Time Validation | Charles Ross, Head of Clinical Operations & Supply, Vaxxas Isolator Procurement for Small to Medium Enterprises | Andrew Exner, (Master Grower) Sante Botanica Disease and pest control. Integrated Pest Management, Facility Design and Personnel International speaker, US |
| 12:30 - 13:30 | Lunch | Lunch | Lunch | Lunch |
| Information Management | Sterile Manufacturing Tools | Industry 4.0 Solutions Today | Medicinal Cannabis | |
| 13:30 - 14:00 | Bassam Masri, Principal Consultant, Statistical Techniques, Minitab Statistics for Process Validation Tutorial | Marc Fini, Technical Services Manager - Astra Zeneca Aseptic Process Validation Kaizen – Investigation and Improvements | Marek Lisik, Product Manger, DCS, Siemens Digital Enterprise in Pharmaceutical Industry | Carl Van Loon, Director PowerPlants Australia Greenhouse design - Australian perspective |
| 14:00 - 14:30 | Bassam Masri, Principal Consultant, Statistical Techniques, Minitab Statistics for Process Validation Tutorial | Darren Pavitt, Senior Director Sales & Market Support APAC , Getinge Life Science Sterile Transfer using DPTE ports | Dr Dominik Holzer, Owner, AEC Connect Australia Digitalisation – Design to Delivery to Deployment | Mike Hoffmann, Cultivation Expert Environmental controls and fertigation International speaker, Canadian |
| 14-30 - 15:00 | Charles Bisignano, Senior Consultant, PharmOut & Varkey Vettoor, Consultant, PharmOut Electronic Validation Management (Valgenesis) | Ashley Isbel. Lead Consultant, PharmOut Draft Annex 1 and New Technology | Jason Mair, Product & Marketing Manager, SICK Pty Ltd Driving your Industry 4ward | Robert Sorba, Conviron Conviron grow chambers International speaker, Canadian |
| 15-00 - 15:30 | Tea/Coffee | Tea/Coffee | Tea/Coffee | Tea/Coffee |
| Final Thoughts | Sterile Manufacturing Practice | Critical Utilities Design & Measurement | Medicinal Cannabis | |
| 15-30 - 16:00 | Matt Schoerie - Senior Consultant, QikSolve Balanced Scorecards: QikSolve learnings in a Quality focused industry | Allan Heckenberg, Executive Diretor, Biosafety GMP Facility Repurposing - Decontamination Steps and Techniques | Barry Gascoigne, Business Development Manager, Prochem Pipeline Products Trends in Stainless Steel Materials & Applications | Trevor Schoerie, Managing Director, PharmOut TGA GMP cannabis facility |
| 16:00 - 16:30 | Tanja Varglien, Lead Consultant, PharmOut Pharmacovigilance | Ashley Isbel. Lead Consultant, PharmOut There is more than one way to get into a cleanroom | William Smillie, Senior Consultant, PharmOut Solutions in applying GMP for Complementary Medicines' Manufacture | Mica Gross, President (Master Grower) Sante Botanica Medicinal Cannabis dosage forms in California International speaker, US |
| 16:30 - 17:00 | N/A | N/A | N/A | Questions & Answers |
