European Computer Validation Conference – the new Annex 11 15-16 May 2012 Copenhagen, Denmark Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1590,--) Book this option: ECA Members (EUR 1390,--) Book this option: EU GMP Inspectorates (EUR 795,--) Book this option: APIC Members (does not include ECA membership) (EUR 1490,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objectives/Background - The new Annex 11 and Chapter 4 set targets and provide a lot of flexibility in interpretation. Inspectors who played a major role in the development of Annex 11 will inform you about the background and content of the new document. - Representatives of the pharma industry will interpret and give their opinion on these regulations. - Together with the participants, the new regulations will be assessed and their practical implementation into practice will be discussed. Binding European requirements regarding computerised systems and their validation are laid down in Annex 11 „computerised systems" of the EU GMP Guide. With regard to current regulatory developments (e.g. on the risk management topic (ICH Q 9 and EU-GMP Guide part III Q 9) and new technological developments (electronic signature, etc.), it had become necessary to revise the Annex. Together with Chapter 4 „Documentation“, the new Annex 11 became enforceable on 30 June 2011. Regulatory compliance objectives have been set simply and briefly and provide enough flexibility for industry to implement them according to its own needs.