2017 National GMP & Validation Forum

A Better Pharmaceutical Manufacturing Industry by Design – the National GMP & Validation Forum. 

Selected GMP and Validation presentations from the 2017 National Forums are available to download here, the spirit of the event was to share the information.

Beginning in 2011 as the National Validation Forum, this started out as not-for-profit event and has been facilitated by PharmOut and supported by the TGA (for the first two years) and most  importantly, local industry.

Support for the event has grown steadily each year, including around the country presentations, as well as in New Zealand and Hong Kong.

Selected Presentations

Day 1

Plenary Presentations

• NGVF 2017 – D1.P3 – TGA PIC/S Version13 Update – Trevor Schoerie
• NGVF 2017 – D1.P4. – Digitalization – Siemens Sachs
• NGVF 2017 – D1.P.5 – EU Regulatory Update – Bryan Wright
• NGVF 2017 – D1.P6 – The Future of Strategic Thinking in Pharma Manufacturing – Harish Aditham
• NGVF 2017 – D1.P8 – Komipharm GOV Assistance – Charles Fridlender

Track 1 Presentations

• NGVF 2017 – D1.T1.4.3 – FDA Inspections – QC Laboratory Considerations Liam Davis
• NGVF 2017 – D1.T1.3.1 – PICS GMP v13 Timeline & Updates – Trevor Schoerie
• NGVF 2017 – D1.T1.3.3 – Microbiology Updates from TGA Therapeutic Goods Orders – Tanja Varglien

Track 2 Presentations

• NGVF 2017 – D1.T2.3.1 – Annex 1 Ashley Isbel
• NGVF 2017 – D1.T2.3.3 – ATMPs – Bryan Wright
• NGVF 2017 – D1.T2.4.1 – Real Time Monitoring Bradley Thomas
• NGVF 2017 – D1.T2.4.2 – Mettler Toledo Roger Strebel

Track 3 Presentations

• NGVF 2017 – D1.T3.3.1 – Emerson Automatinos Solutions_Continuous Manufacturing _Anand Sunit Kulkarni
• NGVF 2017 – D1.T3.3.2 – POD Solutions – Jason Kavanagh
• NGVF 2017 – D1.T3.3.3 – Automated Logistics – Barry Hendy
• NGVF 2017 -D1.T3.4.1 – Pharmaceutical Facility Finishes – Kingspan Kieron Smith
• NGVF 2017 – D1.T3.4.2 – Clearoom Design – Gordan Farquharson

Day 2

Track 1 Presentations

• NGVF 2017 – D2.T1.1.1 – What Lean Means for Quality – Geraldine Murphy
• NGVF 2017 – D2.T1.1.2 – The Quality Quotient – Michele Zammit
• NGVF 2017 – D2.T1.1.3 – Can Quality Metrics Drive Quality Culture – Jeney Isbel
• NGVF 2017 – D2.T1.2.1 QikSolve Deviation Metrics – Matt Schoerie
• NGVF 2017 – D2.T1.2.2 – Comparison of Risk Assessment Techniques -Ahsan SyedAli
• NGVF 2017 – D2.T1.2.3 – Powerful Data Analysis Tools to Ensure Quality Compliance – Ming Dong
• NGVF 2017 – D2.T1.3.1 – Update on Toxicology and Permitted Daily Exposure Requirements – Jacob MacDonald
• NGVF 2017 – D2.T1.3.2 – Cross Contamination & the EU GMP Guide – Bryan Wright
• NGVF 2017 – D2.T1.3.3 – Annex 15 & Cleaning Validaiton – Ashley Isbel
• NGVF 2017 – D2.T1.4.1 – Data Integration and Integrity – It Starts in the Basement – Jacob Tholens
• NGVF 2017 –D2.T1.4.3 – Data Integrity Overview and Case Study Examples- Mark Dickson

Track 2 Presentations

• NGVF 2017 – D2.T2.1.1 – Contamination Control Strategy – Ashley Isbel
• NGVF 2017 – D2.T2.1.2 – Case Study – Cross Contamination – Marc Fini AstraZeneca
• NGVF 2017 – D2.T2.1.3 – Cost and Performance of Isolator and BSC-Cleanroom Technology – Guy Turner
• NGVF 2017 – D2.T2.2.1 – WFI Using Methods Other Than Distillation – Gordan Farqharson
• NGVF 2017 – D2.T2.2.2 – Cleanroom Contamination Biosafety – Brett Cole
• NGVF 2017 – D2.T2.2.3 – Pre Use Post Sterilization Integrity Testing -Michael Schafferius
• NGVF 2017 – D2.T2.3.1 – Sterility Testing in Isolators – Charles Daviau, Getinge
• NGVF 2017 – D2.T2.3.2 – Advances in Single Use Tech – Justin Verwoert
• NGVF 2017 – D2.T2.3.3 – Biodecon – Material Transfer Solutions – Scott Lodge
• NGVF 2017 – D2.T2.4.1 – Airflow Visualisation Studies – Gordon Farquharson
• NGVF 2017 – D2.T2.4.2 – Environmental Monitoring – How to Satisfy the Regulator – Tanja Varglien

Track 3 Presentations

• NGVF 2017 – D2.T3.1.1 – Sustainability in Pharma – Nic van der Nol
• NGVF 2017 – D2.T3.1.2 – Sustainability Utility – Gordon Farquharson
• NGVF 2017 – D2.T3.1.3 – Quality Sustainability and Business Efficiency – Cam Roberts
• NGVF 2017 – D2.T3.2.2 – Benefits of Modularity and Rapid bio-decontamination – Paolo Liverani
• NGVF 2017 – D2.T3.2.3 – Containment Systems Gordon Farquharson
• NGVF 2017 – D2.T3.3.2 Rockwell Software
• NGVF 2017 – D2.T3.3.3 – Smart Factories Industry 4.0 – Ryan Orbell
• NGVF 2017 – D2.T3.4.1 – Next Generation Wireless Design – Bradley Thomas
• NGVF 2017 – D2.T3.4.2 – EMS Qualification – Alan Loughlin
• NGVF 2017 – D2.T3.4.3 – HVAC Design Mistakes – Gordon Farquharson

 

Extras:

• NGVF 2017 – Statistics for Process Validation Training Master Handbook – Eoin Hanley

Sterile Masterclass by Gordon Farquharson

• NGVF 2017- Sterile Masterclass 01 Introduction
• NGVF 2017- Sterile Masterclass 02 CQA and CPP
• NGVF 2017- Sterile Masterclass 03 Process & Manufacturing Technologies
• NGVF 2017- Sterile Masterclass 04 RABS and Isolators
• NGVF 2017- Sterile Masterclass 05 Disposable Technology
• NGVF 2017- Sterile Masterclass 06 Architecture and Layout
• NGVF 2017- Sterile Masterclass 07 Fabric and Finishes
• NGVF 2017- Sterile Masterclass 08 Env Control GMP Requirements
• NGVF 2017- Sterile Masterclass 09 HVAC Systems
• NGVF 2017- Sterile Masterclass 10 HEPA Filters
• NGVF 2017- Sterile Masterclass 11 UDAF systems