09/10/2019
This conference is aiming at presenting, discussing and reviewing the present status of parenteral sterile drugs manufacturing and the focus is on three main topics:
- Parenteral Packaging: evolving trends, industry perspective and CCI considerations
- Visual Inspection of Parenterals
- FDA Regulatory Update and PDA Insights
The program has been designed to present technological development by users and suppliers with a solid industrial experience and to provide a valuable feedback about PDA community current thinking.
This program will give a good balance between industry recent developments delivered by key opinion leaders and SME and also direct interactions at the supplier’s booths. The multidisciplinary nature of the conference as well as the unique interactive atmosphere of all PDA Italy Chapter events, are creating the real differentiating factors among other forum.
Beyond that, a unique opportunity is given to each and every exhibitor and a suitable time to present its product and service portfolio is available in the agenda.
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Moderators: Fernanda Ferrazin, Consultant and EX AIFA GMP Senior Inspector Mauro Giusti, Lilly Italy TSMS Director & Manufacturing Sourcing and Vendor Management |
AGENDA
08:30 – 09:00 Welcome and Registration
09:00 – 09:15 Opening remarks and proposed discussion topic
Angela Molaschi NTC and PDA IT Chapter President
09:15 – 10:45 Parenteral Packaging: evolving trends, industry perspective and CCI considerations
Andrea Simonetti, Xepics and Gabriele Peron, Stevanato Group
Session 1 Packaging Considerations for Cold Storage
Session 2 Glass
Session 3 Considerations on Container Closure Integrity
Session 4 Regulatory Updates
Session 5 Sterilization of Packaging
Session 6 Primary Packaging Choices and Their Technical Impact
10:45 – 11:15 Coffee Break at the sponsors area
11:15 – 12:15 FDA and PDA Perspective: Regulatory harmonization, regulatory science policy and current good Manufacturing practices
Claudio Puglisi, PQE
12:15 – 13.15 News from the SPONSORS
13:15 – 14:15 Networking Lunch at the sponsor area
14:15 – 15:00 Latest outcomes from Visual Inspection Forum
Matteo Rocchi, Lilly Italy
15:00 – 15:30 Case study: Compliant Approach to Implementation of Multi-Staged Inspection that Combines Automated and Manual Methods Techniques
Andrea Cedrola, Patheon, part of Thermo Fisher Scientific
15:30 – 16:00 Coffee Break at the sponsors area
16:00 – 16:30 Overview of the PDA Interest Groups activities
Andrea Simonetti, Xepics
16:30 – 17:00 Open Panel Discussion with Q & A and Final Consideration
GENERAL INFORMATION
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PLANNING COMMETTEE Ceresa Lucia – Charles River Giusti Mauro – Eli Lilly Italia Molaschi Angela – NTC Peron Gabriele – Stevanato Group Simonetti Andrea – Xepics |
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VENUE Hotel FOUR POINTS by SHERATON Via Gerolamo Cardano, 1 - 20124 Milan Metro stop: M2 - Gioia and M3 - Centrale |
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CONFERENCE FEES (VAT 22% included)
Early bird discount: 10% discount for confirmation received within August 31st, 2019
<< FOR REGISTRATION CLICK HERE >> (a regular invoice will be issued by the Organizing Secretariat Centro Congressi Internazionale)
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EXHIBITION/SPONSORSHIP OPPORTUNITIES Exhibition and Sponsorship Opportunities are welcome: A basic exhibition package for this event is priced € 1.300+VAT 22%
Also available the following additional options: + € 500+VAT 22% including two invited attendees (a regular invoice will be issued by the Organizing Secretariat Centro Congressi Internazionale)
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PDA Events & 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 :
- PDA IT-CCI and Visual_Program.3.pdf
