2018 Engineering, GMP & Validation Forum

The 2018 Engineering, GMP & Validation Forum – will be scheduled on 23 / 24 July 2018

Like 2017 it will have a plenary session on the first morning, followed 3 educational tracks.

The speakers and topics will be updated, please check back for the latest additions.

The 2017 GMP Forum Schedule 24/25 July 2017

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





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.