2017 GMP, Engineering & Validation Forum

The 2017 GMP, Engineering and Validation Forum – has 3 educational tracks, followed by 2 days of Master Classes.

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

2017 GMP Forum Proposed Schedule 24/25 July 2017

Back to the GMP Forum

DAY 1 – Monday 24 July 2017

09.00 – 09:05

Welcome and Introduction – Trevor Schoerie, Managing Director, PharmOut

09.05 – 09:45

Medicinal Products – A Patient Perspective – Speaker TBA

09.45 – 10:15

Industry 4.0 – What does it mean to the Pharmaceutical Industry  – Trevor Schoerie, Executive Consultant, PharmOut

10:15 – 10:45

Global GMP Update – Gordon Farquharson

10.45 – 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

Sterile Manufacturing Update – Ashley Isbel, PharmOut

12:00 – 12:30

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

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 – 14:00 PIC/S GMP v13 & 14 – Timeline & Impacts for Australian Manufacturers – Trevor  Schoerie, PharmOut Annex 1 changes in detail (subject to public draft release) – Ashley Isbel, PharmOut Continuous manufacturing – Emerson Automation Solutions
14.00 – 14:30 Case Study – Biopharmaceutical POD facility – Jason Kavanagh, G-Con Manufacturing
14.30 – 15:00 Comparison of RA Techniques – Ahsan Syedali, Qbiotics State of GMP for ATMPs – Bryan Wright, Executive Consultant, PharmOut Automated Logistics – Speaker TBA
15.00 – 15:30 Tea/Coffee
 

Australia, GMP & The Future

Emerging Microbiological Technologies

The Future of GMP Facilities

15.30 – 16:00 New Guidance and Expectations: Elemental Impurities – Trevor Schoerie, Executive Consultant, PharmOut Real time viable microbiological counting (airborne) – Kenelec Sustainability in facility design – Nic van der Nol, PharmOut
16.00 – 16:30 Topic and speaker under consideration. TBA Real Time Microbial Detection: Global Pharmacopeia Acceptance of Alternative Methods – Roger Strebel, Mettler Toledo Sustainability in utility design – Gordon Farquharson, PharmOut
16.30 – 17:00 Topic under consideration. TBA – Ed Jones, Senior Director Global Quality Systems, CSL Behring Rapid microbiological ID methods – speaker TBA, bioMerieux Next generation wireless design – Kenelec Scientific

 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, PharmOut Pharmaceutical facility finishes – Kieron Smith, Kingspan
9.30 – 10:00 Quality Quotient – Michele Zammit, Senior Quality System Manager, Baxter Asia Pacific Case Study – Contamination Control in a Sterile Manufacturing Facility – Marc Fini, Technical Services Manager, AstraZeneca Case Study: New non-sterile facility – Speaker TBA
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 Practical tips for cleanroom design & construction – Warren Jackson, BioConstruct
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 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
11.30 – 12:00 Topic and speaker under consideration. TBA 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
12.00 – 12:30 Case Study: Using Powerful Data Analysis Tools to Ensure Quality Compliance in Pharmaceutical Manufacturing – Ming Dong, Minitab WFI using methods other than distillation – Gordon Farqharson, Executive Consultant, PharmOut Case Study – Containment & Isolation for highly potent OSD production – Jacob MacDonald, 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 – Trevor Schoerie, 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 Topic and speaker under consideration. TBA Topic and speaker under consideration. TBA
14.30 – 15:00 Annex 15 and the changes to cleaning validation requirements – Ashley Isbel, PharmOut Topic and speaker under consideration. TBA Common mistakes in HVAC design – Gordon Farqharson, PharmOut
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 – Emerson Automation Systems Environmental Monitoring – How to satisfy the regulator – Tanja Varglien, Lead Consultant, PharmOut Medicinal cannabis site and equipment selection – speaker TBA
16.00 – 16:30 Designing auditable applications – Shaun Pitt, Senior SharePoint Consultant, QikSolve Effective airflow visualisation studies – Gordon Farquharson, Executive Consultant, PharmOut Medicinal cannabis API  –  facility design, construction, validation and operation – speaker TBA
16.30 – 17:00 Case Study – Computer Systems Validation – Speaker TBA Visual Inspection of Parenteral Products – focus on Annex 1 and USP 790/1790 – Ashley Isbel, Lead Consultant, PharmOut Medicinal cannabis Finished dosage forms –  facility design, construction, validation and operation – speaker TBA
All tracks and times subject to change.

Want to learn more about the Master Classes:
 Sterile/Aseptic Manufacturing – Masterclass
Process Validation & Statistics – Masterclass
PIC/S PE 009-13 GMP & Annex 11 – Masterclass