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 3 educational tracks.

The speakers and topics will be updated regularly as the spots are filled, please check back for the latest additions.

The 2017 GMP Forum Schedule

Below is the 2017 schedule to give you an insight into the breadth of topics covered at the 2017 forum. As you can see it was feature packed with over 50 presentations across the 3 tracks.

Back to the GMP Forum

DAY 1 – Monday 24 July 2017
Plenary Session

09.00 – 09:05

Welcome – Trevor Schoerie, Managing Director, PharmOut

09.05 – 09:35

Medicinal Products – A Patient Perspective – Jim Oommen, Cancer Survivor

09.35 – 10:00

TGA adoption of PIC/S Version 13 – Trevor Schoerie, Managing Director, PharmOut

10:00 – 10:30

Industry 4.0 – What does it mean to the Pharmaceutical Industry – Howard Sachs, Business Development – Chemical & Pharmaceutical, Siemens Ltd Australia

10:30 – 11:00

Tea Break

11.00 – 11:30

EU update including MHRA Inspection Trends 2016/2017 – Bryan Wright, ex Head of GMP/GDP at the MHRA, UK, Executive Consultant, PharmOut

11.30 – 12:00

Future of Strategic Thinking in Pharma Manufacturing – Harish Aditham, Strategic Projects Manager for VP – Supply, AstraZeneca

12.00 – 12:15

AusIndustry and the Pharmaceutical Sector – Ashley Bates, Director, Medical Technologies and Pharmaceuticals, AusIndustry

12:15 – 12:30

Case Study: Real world application of government assistance to the Pharmaceutical Sector – Chales Fridlender, Executive Director, Komipharm International Australia

 12:30 – 13:30

Lunch

TRACK 1

TRACK 2

TRACK 3

General Manufacturing
GMP Compliance & Validation

Sterile & Aseptic Manufacturing
GMP Compliance & Validation

Facility Design & Equipment

PIC/S current GMPs

Annex 1

Innovative Technology

13.30 – 14:00PIC/S GMP v13 – Timeline & Impacts for Australian Manufacturers – Trevor  Schoerie, PharmOutAnnex 1 changes- What we know and what we can guess – Ashley Isbel, Lead Consultant, PharmOutContinuous manufacturing and process automation – Anand Sunit Kulkarni, Life Science Business Leader, Emerson Automation Solutions
14.00 – 14:30Case Study – Prefabricated Cleanroom PODS for the Life Science Industry – Jason Kavanagh, G-Con Manufacturing
14.30 – 15:00Microbiology update from TGA Therapeutic Goods Orders – Tanja Varglien, Lead Consultant PharmOutState of GMP for Advanced Therapy Medicinal Prodcuts (ATMPs) – Bryan Wright, Executive Consultant, PharmOutAutomated Logistics – Barry Hendy. ADDE
15.00 – 15:30Tea/Coffee
 

Australia, GMP & The Future

Emerging Microbiological Technologies

The Future of GMP Facilities

15.30 – 16:00Industry 4.0, a GMP perspective – Trevor Schoerie, Executive Consultant, PharmOutReal time viable microbiological counting (airborne) – Bradley Thomas, Kenelec ScientificPharmaceutical facility finishes – Kieron Smith, Kingspan
16.00 – 16:30Case Study: FDA Inspection – QC laboratory considerations – Liam Davis, Consultant, PharmOutReal Time Microbial Detection: Global Pharmacopeia Acceptance of Alternative Methods – Roger Strebel, Mettler ToledoGood Design Practice for Cleanrooms – Gordon Farquharson, Executive Consultant, PharmOut
16.30 – 17:30

Drinks Function

 DAY 2 – Tuesday 25 July 2017

Quality Metrics & Culture

Contamination Control Strategy

Facility Design & Construction

9.00 – 9:30What “lean” means for quality – Geraldine Murphy, Site Quality Director, Astra ZenecaContamination Control Strategy for Sterile Facilities – Ashley Isbel, Lead Consultant, PharmOutSustainability in facility design – Nic van der Nol, Executive Consultant, PharmOut
9.30 – 10:00Using a Quality System Maturity Model (QSMM) to Drive Continuous Improvement – Michele Zammit, Senior Quality System Manager, Baxter Asia PacificCase Study – Contamination Control in a Sterile Manufacturing Facility – Marc Fini, Technical Services Manager, AstraZenecaSustainability in utility design – Gordon Farquharson, Executive Consultant, PharmOut
10.00 – 10:30   Can quality metrics drive quality culture? – Jeney Isbel, Site Quality Director, Pfizer MelbourneCost and performance comparison of isolator and BSC/cleanroom technology – Guy Turner, BioquellQuality, Sustainability and Business Efficiency through innovation & good engineering – Cameron Roberts, Senior Consultant, PharmOut
10.30 – 11:00Tea/Coffee
 

Data Management & Interpretation

Sterile Manufacturing Hot Topics

 Containment & Isolation

11.00 – 11:30Analysing deviation data in PowerBI  – Matt Schoerie, QikSolveWFI using methods other than distillation – Gordon Farqharson, Executive Consultant, PharmOutCase Study – Containment & Isolation for highly potent OSD production – Jacob MacDonald, PharmOut
11.30 – 12:00Comparison of Risk Analysis Techniques – Ahsan Syedali, QbioticsCleanroom Decontamination – Common issues including mould/fungal contamination – Brett Cole, Managing Director, BiosafetyBenefits of modularity and rapid bio-decontamination for processing in small scale aseptic filling line – Paolo Liverani, Getinge
12.00 – 12:30Case Study: Using Powerful Data Analysis Tools to Ensure Quality Compliance in Pharmaceutical Manufacturing – Ming Dong, MinitabPre-use Post-sterilization Integrity Testing (PUPSIT) of product filters – Micheal Schafferius, Application Specialisit, Sartorius StedimAchieving and demonstrating effective performance of containment systems – Gordon Farquharson, Executive Consultant, PharmOut
12.30 – 13:30Lunch
 

Contamination Control

Sterile Manufacturing Tools

Containment & Isolation

13.30  -14:00Update on Toxicology and Permitted Daily Exposure Requirements for the EU – Jacob MacDonald, Lead Consultant, PharmOutSterility Testing in Isolators – Charles Daviau, GetingeIndustry 4.0 Pharma Applications – Automation Technologies and Advanced Diagnostics – Ryan Orbell, National Segment Manager, Hygeine Processing, Burkert FCS
14.00 – 14:30The Toxicology Model and recent regulatory Q & A’s – Bryan Wright, Executive Consultant, PharmOutAdvances in Single Use Technology – Justin Verwoert, Senior Consultant, PharmOutSiemens Digital Enterprise: Applications in Pharmaceutical Manufacturing – Marek Lisik, Product Manager – DCS, Siemens Ltd Australia
14.30 – 15:00Annex 15 and the changes to cleaning validation requirements – Ashley Isbel, Lead Consultant, PharmOutMaterials Transfer Solutions – Scott Lodge, Country Manager, Biodecon SolutionsMES for the Pharmaceutical Industry – Speaker TBA, Rockwell Automation Australia
15.00 – 15:30Tea/Coffee
 

Data Integrity

Sterile Manufacturing Practice

Critical Utilities Design & Measurement

15.30 – 16:00Data Integrity and Computer Systems Validation considerations for peripheral systems – Anand Sunit Kulkarni, Life Science Business Leader, Emerson Automation SystemsEffective airflow visualisation studies – Gordon Farquharson, Executive Consultant, PharmOutNext generation wireless design – Bradley Thomas, Kenelec Scientific
16.00 – 16:30Data Migration – Shaun Pitt, Senior SharePoint Consultant, QikSolveEnvironmental Monitoring – How to satisfy the regulator – Tanja Varglien, Lead Consultant, PharmOutCommon problems in qualification of Environmental Monitoring Systems – Alan Loughlin, Senior Consultant, PharmOut
16.30 – 17:00Data Integrity Problems – Expectations for investigation and remediation – Mark Dickson, Senior Global Manager for Quality Incidents, NovartisVisual Inspection of Parenteral Products – focus on Annex 1 and USP 790/1790 – Ashley Isbel, Lead Consultant, PharmOutCommon mistakes in HVAC design – Gordon Farqharson, Executive Consultant, PharmOut
All tracks and times subject to change.