Forum A3P Switzerland - CCIT
Container Closure Integrity for Sterile Drug Products: Validation Strategy

Place

Hotel Royal Plaza, Montreux

Date

May 15

volum

Conferences, exhibition, site visit

In accordance with regulatory requirements, containers should be closed by appropriately validated methods. Samples should be checked for each batch for integrity, using validated methods and in accordance with quality risk management. A statistically valid sampling plan should be used.
In accordance with these regulatory requirements in place and in connection with the future 1 Annex, waste rock experts will share their experience on the strategy deployed by their company, the methods and means of controls chosen and implemented to ensure that each unit of Sterile finished product is integral to the output of their production lines.

Welcome of participants
08:30
Introduction
Vincent Griffoul, President A3P Switzerland
9:00
Sterile drug product lifecycle
James Mellman, NOVARTIS
9:10
Container closure integrity control strategy of parenteral drug products: The law and the spirit of the law
Antoine Akar, GSK
09:45
Coffee break - Visit tables tops
10:20
How to ensure Container Closure Integrity (CCI) of Final Containers in Production Routine: key aspects to consider for crimping process
Sandrine Favre, OCTAPHARMA
10:50
Adaptation of a specification for a test of reliability test during a test
Marco Salvagni, DEBIOPHARM
11:25
Lunch - Buffet
12:00
Insulin Pen Cartridges: Container Closure Integrity Life Cycle Management
Henri Hebting, LILLY
13:30
An industry Perspective on CCIT for Sterile Biotech Products
Roman Mathaes, LONZA
14:05
Table Ronde
Dominique Sierakowski
14:40
Visit the site of TRB Chemedica
OU
15:45
Technical conferences
Special studies and hot topics (artificial leaks, pre-filled syringes, frozen DP CCIT)
Roman Mathaes, LONZA
15:45
Optical Emission Spectroscopy, an Emerging Technology for CCIT Containers, which can be used as an alternative to sterility testing and helium testing
Philippe Bunod, PFEIFFER VACUUM
16:25
Coffee break
17:05
Understanding the science behind liquid leak and microbial ingress mechanisms (SU-CCI)
Carole Langlois, SARTORIUS
17:25
The Revised Annex 1 draft and CCI testing Throughout the Product Life Cycle
Josine Wilmer, LIGHTHOUSE
18:05
Dinner at the hotel
19:00

You wish to reserve a stand, please fill in the following form

Access the registration form

Plan of the exhibition

CompanyNo. StandCompanyNo. Stand
ACM PHARMA1 ACTION EUROPE5
2 ALPS AUTOMATION6
PFEIFFER VACUUM3 CCIT7
BORER CHEMIE4 CONFARMA8

Services included with the Table Top stand

  • A dedicated exhibition space on which you can install your products and communication tools: umbrella stand, roll-up, display, product, ... A basic equipment including a table, 2 chairs and 1 electrical connection (2kw) without circuit breaker protection.
  • Breaks and meals indicated in the program
  • Unlimited WiFi
  • A badge that allows you free access to the entire technical and scientific program
  • List of participants in the event
  • Ability to register an additional person at the special "congressist" rate (500 € HT)
[Form inscriptionsuisse not found!]

Contact

According to your requirements and your preferences, you can contact Nina CHATRE:

Phone: + 33 4 37 28 30 47 // + 33 7 58 68 94 49
Fax: +33 (0)4 37 28 30 60
E-mail : nchatre@a3pservices.com
On site: Claude-Nobs Avenue 7, CH-1820 Montreux

Accessibility

Hotel reservation

Royal Plaza Montreux (*****)
Claude-Nobs Avenue 7, CH-1820 Montreux
+ 41 21 962 50 50 / info@royalplaza.ch
http://www.royalplaza.ch/

Grand Hotel Switzerland Majestic (****)
Avenue of the Alps 45, CH-1820 Montreux
+ 41 21 966 33 33 / hotel@suisse-majestic.ch
http://www.suisse-majestic.ch/

Grand Lake Excelsior Hotel (****)
Bon Port Street 27, CH-1820 Montreux
+ 41 21 966 57 57 / info@hotelexcelsiormontreux.ch
http://www.hotelexcelsiormontreux.com/