TGA presentations given at the NVF, 27 June 2012
2 August 2012
**These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which they relate. These papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health and Ageing (of which the TGA is a division) advises that (a) the presentation paper should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation papers.**
Validation of computer systems in a global environment
27 June 2012
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Presentation: Validation of computer systems in a global environment (pdf,660kb)*
- Presented by: Andrew Giles
- Presented at: National Validation Forum on the 27 June 2012 at the Novotel, 285 Springvale Road, Glen Waverley, Melbourne, Australia
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Summary of presentation: The presentation included:
- The discussion of issues related to validations of computer systems in a global network environment. Examples of issues arising from the inspection of global systems and common deficiencies related to computer networked computer systems where presented.
- The presentation explored the questions "When is a computer system required to comply with the code of GMP?" and "Is there more to the inspection of computer systems than validation?"
Common process validation deficiencies: process validation
Presentation: Common process validation deficiencies: process validation (pdf,254kb)
- Presentation by: Mark Dickson, Audit Manager, Medicines from the Office of Manufacturing Quality
- Presented at: National Validation Forum on the 27 June 2012 at the Novotel, Glen Waverley, Melbourne, Australia
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Summary of presentation: The presentation included:
- The PIC/S GMP requirements of Annex 15, utilisation of quality risk management principles, the life cycle approaches to validation and discussed the new approaches by the US FDA and draft EMA guidance on process validation.
Validation and qualification: current issues
Presentation: Validation and qualification: current issues (pdf,141kb)
- Presentation by: Mark Dickson, Audit Manager, Medicines from the Office of Manufacturing Quality
- Presented at: National Validation Forum on the 27 June 2012 at the Novotel, Glen Waverley, Melbourne, Australia
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Summary of presentation: The presentation included:
- Common process validation deficiencies from around the globe.
Content last updated: Wednesday, 27 June 2012
Content last reviewed: Thursday, 2 August 2012
Web page last updated: Thursday, 2 August 2012
URL: http://www.tga.gov.au/newsroom/events-presentations-nvf-120627.htm