GMP & Engineering Forum 2017 Schedule

The GMP, Engineering & Validation Forum in 2017 with the kind help from the sponsors we managed to facilitate the 7th GMP & Validation Forum on Monday and Tuesday the 24th and 25th July 2017, followed by Master Classes on the 26th and 27th July.

  1. Sterile / Aseptic Manufacturing,
  2. Process Validation & Statistics (includes new version 13 Annex 15)
  3. PIC/S Version 13, (includes the new version 13, Annex 11, Data Integrity)

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





General Manufacturing
GMP Compliance & Validation

Sterile & Aseptic Manufacturing
GMP Compliance & Validation

Facility Design & Equipment

PIC/S current GMPs

Annex 1

Innovative Technology

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

Australia, GMP & The Future

Emerging Microbiological Technologies

The Future of GMP Facilities

15.30 – 16:00 Industry 4.0, a GMP perspective – Trevor Schoerie, Executive Consultant, PharmOut Real time viable microbiological counting (airborne) – Bradley Thomas, Kenelec Scientific Pharmaceutical facility finishes – Kieron Smith, Kingspan
16.00 – 16:30 Case Study: FDA Inspection – QC laboratory considerations – Liam Davis, Consultant, PharmOut Real Time Microbial Detection: Global Pharmacopeia Acceptance of Alternative Methods – Roger Strebel, Mettler Toledo Good 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 – 9:30 What “lean” means for quality – Geraldine Murphy, Site Quality Director, Astra Zeneca Contamination Control Strategy for Sterile Facilities – Ashley Isbel, Lead Consultant, PharmOut Sustainability in facility design – Nic van der Nol, Executive Consultant, PharmOut
9.30 – 10:00 Using a Quality System Maturity Model (QSMM) to Drive Continuous Improvement – Michele Zammit, Senior Quality System Manager, Baxter Asia Pacific Case Study – Contamination Control in a Sterile Manufacturing Facility – Marc Fini, Technical Services Manager, AstraZeneca Sustainability in utility design – Gordon Farquharson, Executive Consultant, PharmOut
10.00 – 10:30    Can quality metrics drive quality culture? – Jeney Isbel, Site Quality Director, Pfizer Melbourne Cost and performance comparison of isolator and BSC/cleanroom technology – Guy Turner, Bioquell Quality, Sustainability and Business Efficiency through innovation & good engineering – Cameron Roberts, Senior Consultant, PharmOut
10.30 – 11:00 Tea/Coffee

Data Management & Interpretation

Sterile Manufacturing Hot Topics

 Containment & Isolation

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

Contamination Control

Sterile Manufacturing Tools

Containment & Isolation

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

Data Integrity

Sterile Manufacturing Practice

Critical Utilities Design & Measurement

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