Congresso con visita di stabilimento.
The Single Use Technologies - technically “disposable”- play a predominant and growing role in the development of new products and processes. More and more companies are constantly offering pre-assembled gamma systems that are irradiated and ready to use. For example, it has been amply demonstrated, in fact, how preassembled disposable systems reduce the risk of contamination, improve production efficiency and overall equipment efficiency (OEE).
In addition, thanks to their flexibility, the transfer times of the processes, from both site to site in case of scale up, are greatly reduced.
Although these credentials lay the foundations for a growing liking, there are still some latent doubts and unresolved questions. What are the parameters that allow to determine if the use of disposable within a process is convenient?
How to predict the interaction between plastic materials and product?
Is it more appropriate to use a leachable or extractable solution?
How to assure that the disposable is sterile?
What minimum standards are required of suppliers of disposable technologies for their use in sterile applications?
What about parenteral products?
Are there good practices in the design of assembled and ready-to-use systems?
“Single Use and Innovative Technologies to face new Regulatory Challenges” congress aims to deepen, among the various topics, also these points of discussion sharing the experience of those societies that have already elaborated and faced them, implementing the technology disposable in their production process.
PDA Italy Planning Committee
Lucia Ceresa - Charles River
Mirko Gabriele - Thermofisher
Angela Molaschi – NTC
Giuseppe Paganini - Merck Italia
Gabriele Peron - Stevanato Group
Michele Simone - Bracco Suisse SA
Filippo Trionfera - BSP Pharmaceuticals
Congress Venue
Hotel Mediterraneo
Via Cavour, 15 - 00184 Roma
www.romehotelmediterraneo.it
REGISTRATION - Conference Fees (VAT 22% included)
€ 500,00 - PDA member
€ 650,00 - PDA NON member
€ 900,00 - for 2 colleagues for the conference at the same time
€ 1.200,00 - for 3 colleagues for the conference at the same time
CERTIFICATE OF ATTENDANCE
The certificate can be downloaded from the link below from November 22nd to December 31st, using the credentials get during the registration proces. The same will be sent again at the end of the event.
Manufacturing Plant Tour
Patheon Thermofisher
2 Trav. SX Via Morolense 5 03013 Ferentino
BSP Pharmaceuticals
Via Appia, 04013 Latina
The transfer to and from the Plant will be organized by the CCI Secretariat. Punctuality is recommended. The return is scheduled for 17.00 at Termini Station, Rome.