The 2011 National Validation Forum
A Better Pharmaceutical Manufacturing Industry by Design – the National GMP & Validation Forum.
Selected GMP and Validation presentations from the 2011 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, the forum started out in frustration as validation was being done ineffectively, we wanted to help improve our own and industry’s approach. Starting out as not-for-profit type event, so enable TGA involvement, it has been facilitated by PharmOut over the years, however it was only supported by the TGA for the first two years. The event has continued to enjoy local industry support and has grown steadily over the years. The primary intent of the Forum is to enhance GMP practices in an open collaborative manner, this included around the country presentations, as well as loops into New Zealand and Hong Kong when deemed appropriate.
A significant driver for the Forum was the release of the ICH Q8, Q9, Q10 and Q11 documents and a ICH event attended by a number of PharmOut consultants, and the release of the draft and later the final FDA Process Validation Guidance, PharmOut tried to facilitate practical steps to close the gap between Australian manufacturers and our international markets.
The above spawned an open collaborative, knowledge sharing environment, through sharing talks by industry thought leaders and of course sharing PDF of presentations provided the presenter gave their permission, the objective is A Better Australian Pharmaceutical Industry by Design.