GMP & Engineering Forum 2018 Schedule

GMP & Engineering Forum 2018
Schedule of Events

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.

Day 1
Plenary Session

9:00 - 9:05Trevor Schoerie, Managing Director PharmOut
Welcome
9:05 - 9:45Andrew Hodder, Site Lead, Pfizer Melbourne
TBA
9:45 - 10:30Trevor Schoerie, Managing Director PharmOut,
Australian Medicinal Cannabis
10:30 - 11:00Tea/Coffee
11:00 - 11:30Bob Lenich, Life Sciences Business Director, Emerson Automation Solutions
BioPhorum Technology Roadmap
11:30 - 12:00Charles Ross, Head of Clinical Operations & Supply, Vaxxas
Revolutionising Vaccination
12:00 - 12:30Maria Mylonas, Training Services Manager, PharmOut
PIC/S PE009-13 Highlights of Changes  & The Path Ahead
12:30 - 13:30Lunch

Day 1
Main Sessions

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 RegulationsNew Sterile GuidanceInnovative TechnologyMedicinal Cannabis
13:30 - 14:00Seamus 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)
TBAMike Hoffmann, Canadian Cultivation expert
Cultivation on scale
International speaker, Canada
14:00 - 14:30Jeney 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
Temperature Monitoring Case Studies
Mica Gross, President (Master Grower) Sante Botanica
Strain Selection - which strain is best for you?
International speaker, Canada
14:30 - 15:00Mark Dickson, Director of Quality Assurance, Compliance, CSL Behring
Annex 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
TBA
Mike Hoffmann, Canadian Cultivation expert
Fertigation considerations
International speaker, Canada
15:00 - 15:30Tea/CoffeeTea/CoffeeTea/CoffeeTea/Coffee
Evolving QualityEmerging Microbiological TechnologiesLogisticsMedicinal Cannabis
15:30 - 16:00Stoyan Atanasov, Senior QA Associate, CSL Behring
Continuous Quality Improvement
TBATBALocal suppliers
Optimal Cannabis Head and Grow House considerations
16:00 - 16:30David Doolan. QA Manager, Quest Pharma
TBA
Michael Payne, Biosafety Technical Consultant, Merck Millipore
Technological and Engineering Innovations around sterile medicinal product filtration
TBALocal producer
Australian experience so far
16:30 - lateDrinks FunctionDrinks FunctionDrinks FunctionDrinks Function

Day 2
Main Sessions

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 CultureContamination Control StrategyNext Generation FacilitiesMedicinal Cannabis
09:00 - 09:30Maria Mylonas, Training Services Manager, PharmOut
Fostering Quality Culture
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 - 10:00TBA, Astra Zeneca
TBA
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
Mica Gross, President (Master Grower) Sante Botanica
Preserving strain
International speaker, US
10:00 - 10:30Keith Johnson, Production Manager, Grunbiotics
Quality and Production Relationship Building
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 Hoffmann, Canadian Cultivation expert
Commercial scale cannabis considerations
International speaker, Canadian
10:30 - 11:00Tea/CoffeeTea/CoffeeTea/CoffeeTea/Coffee
Case StudiesSterile Manufacturing Hot TopicsContainment & IsolationMedicinal Cannabis
11:00 - 11:30Debbie Parker - Head of Quality, Vaxxas
TBA
Michael Payne, Biosafety Technical Consultant, Merck Millipore
Regulatory Trends in Manufacturing of Sterile Medicinal Products by Filtration
Keith Wilson, Sales Manager, ANZ, Critical Scientific Solutions
Plug and Play Facility Access & Door Control
Mike Hoffmann, Canadian Cultivation expert
Lighting considerations
International speaker, Canadian
11:30 - 12:00Annette Grundy - Director, Strategy and Operational Excellence, Baxter International
TBA
Tony Ross, Engineering & Validaton Manager, Pfizer
TBA
TBAMica Gross, President (Master Grower) Sante Botanica
Optimal temperature, humidity and CO2
International speaker, US
12:00 - 12:30Trevor Schoerie - Managing Director, PharmOut
PIC/S version 14, contamination control - case study
Ashley Isbel. Lead Consultant, PharmOut
A key Annex 1 controversy in-depth
Charles Ross, Head of Clinical Operations & Supply, Vaxxas
Isolator Procurement for Small to Medium Enterprises
Mica Gross, President (Master Grower) Sante Botanica
Disease and pest control
International speaker, US
12:30 - 13:30LunchLunchLunchLunch
Information ManagementSterile Manufacturing ToolsIndustry 4.0 Solutions TodayMedicinal Cannabis
13:30 - 14:00Matt Schoerie - Senior Consultant, QikSolve
TBA
TBA, Astra Zeneca
TBA
Marek Lisik, Siemens
TBA
TBA
Greenhouse design
14:00 - 14:30Bassam Masri, Principal Consultant, Statistical Techniques, Minitab
Statistics for Process Validation Tutorial
Darren Pavitt, Senior Director Sales & Market Support APAC, Getinge Life Science
TBA
Bob Lenich, Life Sciences Business Director, Emerson Automation Solutions
Digital Transformations
Robert Sorba, Conviron
Argus control systems
International speaker, Canadian
14-30 - 15:00Bassam Masri, Principal Consultant, Statistical Techniques, Minitab
Statistics for Process Validation Tutorial
Trevor Schoerie, Executive Consultant, PharmOut
A report from ACHEMA
Jason Mair, Product & Marketing Manager, SICK Pty Ltd
Driving your Industry 4ward
Robert Sorba, Conviron
Conviron grow chambers
International speaker, Canadian
15-00 - 15:30Tea/CoffeeTea/CoffeeTea/CoffeeTea/Coffee
GMP Hot TopicsSterile Manufacturing PracticeCritical Utilities Design & MeasurementMedicinal Cannabis
15-30 - 16:00Dina El-Emary, Continuous Improvement and Compliance Manager, CSL Behring
Data Integrity Quality Initiatives
Allan Heckenberg, Executive Diretor, Biosafety
TBA
TBAMaria Mylonas, Training Services Manager, PharmOut
TGA GMP Cannabis facilities considerations
16-00 - 16:30Charles Bisignano, Senior Consultant, PharmOut
Electronic Validation Management (Valgenesis)
Marc Fini, Technical Services Manager - Astra Zeneca
TBA
TBA, Prochem Pipeline Products
TBA
Trevor Schoerie, Managing Director, PharmOut
Product (Cannabis) registration / listing
16-30 - 17:00Tanja Varglien, Lead Consultant, PharmOut
Pharmacovigilence
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 Complimentary Medicine Manufacture
Mica Gross, President (Master Grower) Sante Botanica
Medicinal Cannabis dosage forms in California
International speaker, US
Please be aware the schedule is a work in progress and changes may be necessary.