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.
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
PLANNING COMMETTEE
Ceresa Lucia – Charles River
Giusti Mauro – Eli Lilly Italia
Molaschi Angela – NTC
Peron Gabriele – Stevanato Group
Simonetti Andrea – Xepics
VENUE
Hotel FOUR POINTS by SHERATON
Via Gerolamo Cardano, 1 - 20124 Milan
Metro stop: M2 - Gioia and M3 - Centrale
CONFERENCE FEES (VAT 22% included)
€ 183 University and Regulators
€ 549 PDA member
€ 671 PDA NON-member
€ 854 for 2 colleagues for the conference at the same time
€ 1.037 for 3 colleagues for the conference at the same time
Early bird discount: 10% discount for confirmation received within August 31st, 2019
EXHIBITION/SPONSORSHIP OPPORTUNITIES
Exhibition and Sponsorship Opportunities are welcome:
A basic exhibition package for this event is priced € 1.300+VAT 22%
(table-top + 2 people pass for the conference)
Also available the following additional options:
+ € 500 +VAT 22% including two invited attendees