Resources

• Ethylene Oxide & Gamma Sterilisation: Trials and Tribulations, 18 September 2012, Presentation One
  “Ethylene oxide and radiation sterilization - How to cross the finishing line without a false start” by Karen Longstaff, Principal Microbiologist, Office of Laboratories & Scientific Services, TGA
• Ethylene Oxide & Gamma Sterilisation: Trials and Tribulations, 18 September 2012, Presentation Two
  “Qualification of Ethylene Oxide and Gamma sterilisation processes” by Daniel Lanzon, Microbiology Manager, Pfizer
• Ethylene Oxide & Gamma Sterilisation: Trials and Tribulations, 18 September 2012, Presentation Three
  “Ethylene Oxide and Radiation Sterilization: Method selection and critical success factors?” by Barry Cox, Group Quality Manager, Steritech
• Ethylene Oxide & Gamma Sterilisation: Trials and Tribulations, 18 September 2012, Presentation Four
  “CRG on the move – Challenges of EtO sterilisation and revalidation” by Jayde Foster, CRG Quality Manager & Celli Clews, CRG LEAN Manager, CRG
• Single Use Systems, 20 March, 2012 - Presentation One
  "Single Use Technologies - Overview and Business Drivers" by Luke Heaven, Director of Marketing (EU/Asia/NEMEA/Cuba), Sartorius Stedim Biotech
• Single Use Systems, 20 March, 2012 - Presentation Two
  "PDA Technical Report on Single-Use Systems" by Jerold Martin, Sr. VP, Global Scientific Affairs, Pall Life Sciences
• Single Use Systems, 20 March, 2012 - Presentation Three
  "Single-use and Sustainability: Core Design Philosophies for the New DSM Biologics Facility" by Ben Hughes, Senior Process Engineer, DSM Biologics
• Single Use Systems, 20 March, 2012 - Presentation Four
  "Single-Use Systems for Pharmaceutical Applications: CSL's Large Scale Cell Culture Facility" by Tim Hughes, Sr. Director, Clinical Manufacturing (R&D), CSL Ltd.
• Media Fills and Environmental Monitoring, 26 July, 2011 - Presentation One
  "Media Fills: The Microbiology Way" by Kate Rusbridge, OLSS Microbiology Section, TGA
• Media Fills and Environmental Monitoring, 26 July, 2011 - Presentation Two
  "A Practical Approach to Media Fills" by John Garkinis, QA Manager, CSL Biotherapies
• Media Fills and Environmental Monitoring, 26 July, 2011 - Presentation Three
  "Media Fills and Environmental Monitoring" By Ano Xidias, Senior Consultant, PharmOut
• FDA's Process Validation Guidance, 12 May, 2011 - Presentation One
  "FDA's Process Validation Guidance: The Guidance, the Regulator and the Manufacturer" by Dr. Andrzej Wozniak, PharmOut
• FDA's Process Validation Guidance, 12 May, 2011 - Presentation Two
  "The Value of Simple Statistics in Retrospective Process Validation" by Brad Roberts, SeerPharma
• FDA's Process Validation Guidance, 12 May, 2011 - Presentation Three
  "A Practical Approach to Process Validation" by Paul McDonald, Hospira
• Annual Product Review: Developing an SOP
  by Steve Williams, SeerPharma P/L, September 2010
• Update to the Manufacturing Principles for Medicinal Products
  In July 2010 the TGA will adopt the PIC/S Guide to Good Manufacturing Practices for Medicinal Products as the applicable Code of GMP under Manufacturing Principles determined under Section 36 of the Therapeutic Goods Act 1989. The adoption reflects TGA's intention to maintain standards in line with international best practice. The presentation was to explain how the TGA would interpret and implement the new requirements.
• Lean Laboratory Implementation - Ivy Leung; GSK
  Ivy discussed the implemetnation of lean laboratory systems at GSK's Boronia site.
• "A Risky Night" - Risk Management, Presentation One, 21 April 2009
  Supply Chain Challenges and Risk Management, by Steve Williams (751 KB)
• "A Risky Night" - Risk Management, Presentation Two, 21 April 2009
  Risk Assessment - Where to Next?, by Alf Esteban (779 KB)
• Global Manufacturing Update - Key Issues and Opportunities
  Michel Lok, December 2008
• Desktop Audits - Lessons Learned and Ways Forward
  December 2008
• Application of Lean Sigma
  Ivy Leung, 29th July 2008
• The External OOS
  29th July, 2008
• Laboratory Investigations- A Regulatory Perspective
  Jenny Hantzinikolas, 29th July 2008
• Validation of Sterilising and Virally Retentive Filters
  Michael Payne, 13th May 2008
• PDA TR #26 Update Sterilizing Filtration of Liquids Meeting Validation Requirements
  by Esha Pillay