2016 National GMP & Validation Forum
Selected Presentations from 2016 PharmOut GMP Forum
Not all presentations from the forum are able to be shared. Below are those where permission has been granted by the speaker.
Day 1
Plenary Presentations
- NGVF 2016 – D1.P0 – Slide Show breaks
- NGVF 2016 – D1.P1 – Trevor Schoerie – Welcome
- NGVF 2016 – D1.P3 – GMP & Validation – from disaster, via overkill, to common sense – Gordon Farquharson
- NGVF 2016 – D1.P4 – Roy Cherris – Hot Topics Currently in Focus by the US-FDA
- NGVF 2016 – D1.P5 – Ashley Isbel – Conference Overview & Interactivity Tool
- NGVF 2016 – D1.P6 – Bryan Wright – EU Regulatory Update
- NGVF 2016 – D1.P7 – Bob Tribe – International Regulatory Convergence – Is enough being done
- NGVF 2016 – D1.P8 – Eoin Hanley – Data Integrity, Blockchain Technology and the Internet of Things
Track 1 Presentations – General Manufacturing
- NGVF 2016 – D1.T1.3.1 – Trevor Schoerie – EU GMPS & Impact on Australian GMP
- NGVF 2016 – D1.T1.3.2 – John Montalto – Keep the Faith – Ageing Plant Compliance
- NGVF 2016 – D1.T1.3.3 – Eoin Hanley – Is Knowledge Management part of your Pharmaceutical Quality System
- NGVF 2016 – D1.T1.4.1 – Deb Cailes – Case Study – FDA ANDAs and legacy QbD approach
- NGVF 2016 – D1.T1.4.2 – Clare Schwarz – Product Quality Reviews
- NGVF 2016 – D1.T1.4.3 – Ahsan SyedAlli – A practical approach for implementing product lifecycle and control strategy for API manufacturing processes
Track 2 Presentations – Sterile & Aseptic Manufacture
- NGVF 2016 – D1.T2.3.1 – Gordon Farquharson – RABS & Isolators Barrier Technology
- NGVF 2016 – D1.T2.3.2 – Ashley Isbel – Advanced Therapy Medicinal Products and GMP
- NGVF 2016 – D1.T2.3.3 – Brett Cole – Rapid Decontamination Systems
- NGVF 2016 -D1.T2.4.1 – Gordon Farquharson – WFI – New Ph Eur Production Specification
- NGVF 2016 – D1.T2.4.2 – Gordon Farquharson – WFI – New Ph Eur Selecting the best production option
- NGVF 2016 – D1.T2.4.3 – Roger Strebel – Rapid Microbial Measurement
Track 3 Presentations – Facility Design & Equipment
- NGVF 2016 D1.T3.4.1 – Craig Abbott – Wireless Technology Update
- NGVF 2016 – D1.T3.4.2 – Gary Ward – Scientific Approach to Cool Room Validation
- NGVF 2016 – D1.T3.3.1 – Barry Hendy – Innovation in Automation
- NGVF 2016 – D1.T3.3.2 – Marco Preus – Advancements in Isolation Technology for Aseptic Filling
- NGVF 2016 – D1.T3.3.3 – John Nesbitt – RFID and barcode technology in GMP
Day 2
Track 1 Presentations – General Manufacturing
- NGVF 2016 – D2.T1.1.2 – Matthew Schoerie – Cost Effective Quality Management Systems
- NGVF 2016 – D2.T1.1.3 – Shaun Pitt – EQMS Implementation
- NGVF 2016 – D2.T1.2.1 – Trevor Schoerie – Process Validation – Measuring what matters
- NGVF 2016 – D2.T1.2.2 – Ming Dong – Using Data Analysis to Improve Quality, Save Money & Increase Productivity
- NGVF 2016 – D2.T1.2.3 – Matt Kennett – EMS Project Management – From URS to handover
- NGVF 2016 – D2.T1.3.1 – Ed Jones – CSL Behring – Aligning Quality Processes
- NGVF 2016 -D2.T1.3.2 – Eoin Hanley – DI – A Study of Thinking and Regulatory Action
- NGVF 2016 – D2.T1.3.3 – Marc Fini – Data Integirty – Practical_Applications
- NGVF 2016 -D2.T1.4.1 – Bryan Wright – Wholesaling & Distribution & the GMPs
Track 2 Presentations – Sterile & Aseptic Manufacture
- NGVF 2016 – D2.T2.1.1 – Bryan Wright – Update on revision of Annex 1
- NGVF 2016 – D2.T2.1.2 – Gordon Farquharson – Impact of new ISO 14644-1and2 – 2015 On GMP Annex 1
- NGVF 2016 – D2.T2.1.3 – Ashley Isbel – Sterile Processing – Current Challenges in Annex 1
- NGVF 2016 – D2.T2.2.1 – Ashley Isbel – Sterile Compounding
- NGVF 2016 – D2.T2.2.2 – Roy Cherris – Particle Determination – Guidance for Parenteral Products
- NGVF 2016 – D2.T2.2.3 – Roy Cherris – Quality (QA-QC) Methods Trending and Monitoring of Particulate Matter
- NGVF 2016 – D2.T2.3.1 – Daniel Clifford – Sterilization Liquid Loads Description
- NGVF 2016 – D2.T2.3.2 – Andreas Kocourek – Disposable Technology Qualified Disposable Materials
- NGVF 2016 – D2.T2.3.3 – David Felici – Microbiological monitoring of clean rooms – A New Approach
- NGVF 2016 – D2.T2.4.1 – Annette Grundy – Best Practice in Environmental Monitoring
- NGVF 2016 – D2.T2.4.2 – Gordon Farquharson – Bio-contamination control PHSS Technical Monograph No. 20
Track 3 Presentations – Facility Design & Equipment
- NGVF 2016 – D2.T3.2.1 – Bradley Thomas – Particle Counting Systems – Design, Installation & Qualification Challenges
- NGVF 2016 – D2.T3.2.2 – Ryan Orbell – Flow Measurement with FLOWave flowmeters in clean utility applications
- NGVF 2016 – D2.T3.2.3 – Jason Kavanagh – Modular Cleanrooms
- NGVF 2016 – D2.T3.3.1 – Marco Preus – Containment Solutions
- NGVF 2016 – D2.T3.3.2 – Gordon Farquharson – Facility design for containment
- NGVF 2016 – D2.T3.3.3 – Gordon Farquharson – Contained processes and equipment
- NGVF 2016 – D2.T3.3.4 – Jacob MacDonald – Continuous Manufacture OSD
- NGVF 2016 – D2.T3.1.2 – Kieron Smith – Clean Room Construction
- NGVF 2016 – D2.T3.1.3 – Cameron Roberts – Engineering a blood processing facility for viral safety
Extras:
Roy Cherris Masterclass:
- NGVF 2016 – Holistic life cycle model checklist
- NGVF 2016 – USP 790-Visible particles-USP37
- NGVF 2016 – Visual Inspections of Injection
- NGVF 2016 – Cherris Masterclass – Slide Master
- NGVF 2016 – Example of how to set up a defect Library
- NGVF 2016 – Generic Attributes Requirements Glass Vials
- NGVF 2016 – Generic Filled Product Defect Classification
- NGVF 2016 – Generic Human Inspectior Qualification Test Set Mar-2014
- NGVF 2016 – Pages from ANSI-ASQZ1.4-2003
- NGVF 2016 – USP 790-Visible particles-USP37
- NGVF 2016 -Generic Human Inspection Threshold Detection Test Set Mar-2014
