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Single Use and Innovation Technologies to face new Regulatory Challenges

  21/11/2019 - 22/11/2019


21-22 novembre 2019, Roma

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.

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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

 

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Congress Venue

Hotel Mediterraneo

Via Cavour, 15 - 00184 Roma

www.romehotelmediterraneo.it

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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.


<< CLICK HERE TO DOWNLOAD THE CERTIFICATE >> 

 

 

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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.

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PDA Organizing Secretariat

Centro Congressi Internazionale S.r.l.

Via San Francesco da Paola, 37 – 10123 Torino
Tel. 011/2446925 – fax 011/2446950 – e-mail: pda@pda-it.org

web: www.pda-it.org

 


Allegati :


- Disposable Technologies Call For Paper.pdf
- Programma Single Use 15.11.2019.pdf



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