PDA Italy Chapter: Managing Disinfection Within an Advanced CC
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Annex 1 indicates clear requirements for Cleaning and Disinfection which are key elements included in the Contamination Control Strategy (CCS) as a holistic and mandatory process for the manufacture of sterile products.
Based on the process understanding, appropriate risks assessment and mitigation measures should be applied considering potential impact on the quality of the final sterile product with the final goal to create a specific quality assurance-approved disinfection and monitoring program able to ensure the required compliance.
Materials utilized for the construction of the room and for items used within the cleanroom, should be selected to minimize particle generation and to allow the suitable use of the cleaning and disinfectant agents.
Several case studies will describe practical solutions for: glove management and materials handling, cleaning, sanitizing agents, disinfectants evaluation, materials compatibility, and frequency program and sanitization technologies.
Program Highlights
Language
The official languages are Italian and English. No simultaneous translation is provided.The presentations (.ppt slides) will be in English.
Organizing Committee
Mirko Gabriele / President PDA Italy Chapter
Mauro Giusti / Lilly Italia – PDA Italy Past Chapter President
Angela Molaschi / Pharmatex – Past-Past President PDA Italy Chapter
Filippo Trionfera / BSP Pharmaceuticals – President-elect PDA Italy Chapter
Gabriele Peron / Stevanato Group - PDA Italy Chapter Board
Claudio Puglisi / Entourage - PDA Italy Chapter Board
Lucia Ceresa / Charles River Microbial Solution - PDA Italy Chapter Steering
Francesco Boschi / Pfizer-AFI
Agenda
Discover What's Happening Each Day
12:40-14:00 | Arrival, registration & Welcome buffet at AM Instruments Limbiate site
14:00-14:15 | Opening remarks and proposed discussion topic – PDA Italy Chapter / AFI
14:15-14:30 | Welcome and Introduction – Maria Adele Imro & Massimo Mannini, AM Instruments
14:30-15:00 | Clean rooms sanitizing technology – Emanuele Salmaso & Antonio Evangelista, Fresenius Kabi iPSUM
15:00-15:30 | Tim Sandle (confirmed)
15:30-16:00 | Managing residues - How can cleaning and disinfectant residues be a risk to product quality? What can be done to control them in a cleanroom environment? – David Keen, Ecolab
16:00-16:10 | Sponsors’ Welcome
16:10-16:45 | Coffee break
16:45-17:15 | Selection and rotation of disinfectants for DCS (Drug Containment Solution) – Greta Franzoso & Francesca Squizzato, Stevanato Group
17:15-17:45 | Hard to Kill Bugs: Identifying resistant Species – Duncan Barlow, Microbial Solutions, Charles River
17:45-18:15 | Rationalization of the cleaning and disinfection program - Valentina Farsetti, Consultant
18:15-18:45 | Panel discussion with all speakers. Chairs: Fernanda Ferrazin, Life Science Consultant, former Senior AIFA GMP Inspector and Marisa Delbò, former AIFA Chief GMP Inspectorate
18:45-19:00 | Wrap-up and final remarks from Day 1, PDA Italy Chapter/AFI
19:00-19:30 | Happy Hour with the Sponsors
19:45-22:00 | Networking dinner at Palazzo Borromeo (Cesano Moderno - MI)
08:45-09:00 | Arrival & registration DAY-2 at AM Instruments Limbiate site
09:00-09:15 | Opening remarks and proposed discussion topic – PDA Italy Chapter
09:15-09:45 | Cleaning and disinfection within CCS program – Francesco Boschi, Pfizer/AFI
09:45-10:15 | Contamination control in aseptic production – Application of sterile packaging and protective solutions in the pharmaceutical industry– Juha-Pekka Pöyry, Dupont Tyvek® Healthcare Packaging
10:15-10:45 | Managing cleaning and disinfection for Isolator use – Massimiliano Frasca, BSP
10:45-11:15 | Coffee break
11:15-11:45 | Grade A continuity: contact parts management for transfer into isolator technology – Fabrizio Gelli, GSK Vaccines Rosia
11:45-12:15 | Control and qualification of Rapid Transfer Port – Lorenzo Mazzetti, Thermo Fisher Scientific / Monza
12:15-13:00 | Lunch
13:00-14:30 | AM Instruments Factories Tour
14:30-15:15 | AIFA Inspector (Invited)
15:30-15:45 | Panel discussion with all Speakers. Chairs: Fernanda Ferrazin, Life Science Consultant, former Senior AIFA GMP Inspector and Marisa Delbò, former AIFA Chief GMP Inspectorate
15:45-16:00 | Wrap-up and Closing Remarks, PDA Italy Chapter/AFI
Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Convention Hotel
AS Hotel Limbiate Fiera
When booking online, enter code: AMIN
Congress Venue
AM Instruments Via Isonzo, 1/c, 20812 Limbiate MB
Day 2, Friday March 15th, 2024: 13:00 -14:30:
Manufacturing Plants Tour at AM Instruments Plant in Limbiate and AM Instruments Plant in Cesano Maderno MB.
Transfer will be arranged by CCI/PDA Italy Secretariat - AM Instruments.
Registration
Pricing Options
| Registration Type | Registration Fee |
|---|---|
| University and Regulators | €122.00 |
| PDA and AFI members | €366.00 (Friday only: € 219.00) |
| PDA and AFI NON-members | € 549.00 (Friday only: € 329) |
| 2 Colleagues for the Conference at the Same Time | € 732.00 |
| 3 Colleagues for the Conference at the Same Time | € 1,038.00 |
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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