MICROBIOLOGY

Rapid microbiology - Alternative Methods - Regulatory

LOCATION

Novotel Madrid City Las Ventas

Madrid, Spain

Date

7 april 2022

Format

Conferences, Workshops, Exhibition, Networking

Microbiological control in the pharmaceutical industry is one of the fundamental pillars to have safe medicines in the market.

This year, your reference association and the A3P Spain Committee invite you to participate in the presential event within the framework of microbiological quality control:

→ Incorporate rapid microbiology into pharmaceutical production processes increases productivity and safety, allows for earlier detection of any contamination and for fast and effective action.

🎧 simultaneous translation service : Spanish / English

Welcome of the participants
09:00
Introduction
A3P Spain Committee
09:30
European Pharmacopeia and Alternative Microbiological Method
Thierry BONNEVAY – SANOFI & Ph.Eur.
09:45
Use of alternative methods for the Microbiological control of medicinal products: How to implement them from a regulatory point of view
Susana LOPEZ HERNÁNDEZ – AEMPS (Spanish Agency for Medicines and Health Products) & Ph.Eur.
10:15
Coffee break – Visit to the exhibition
11:00
Viable environmental monitoring as a tool for CCS
Beatriz ROQUÉS – REIG JOFRE
12:00
Partners’ workshops: Session 1
Associates of Cape Cod – bioMérieux – Charles River – Novatek International – Steris
12:30
Lunch – Visit to the exhibition
13:30
Partners’ workshops: Session 2
Associates of Cape Cod – bioMérieux – Charles River – Novatek International – Steris
14:45
Partners’ workshops : Session 3
Associates of Cape Cod – bioMérieux – Charles River – Novatek International – Steris
15:45
Pause
16:45
Real-time monitoring of biological and inert particles in production environments
Esther BELLON & Victoria NAVARRO – PFIZER
17:15
Rapid Microbiology Methods implementation in accordance with new EU GMPs Annex1 V12 Draft.
Gilberto DALMASO – VELTEK ASSOCIATES
17:45
RMM Round Table – Conclusion and discussion
End of the event
18:30 pm

› SPEAKERS

🎧 simultaneous interpretation: English / Spanish

Thierry BONNEVAY / SANOFI (Ph. Eur.)

Ester BELLON / PFIZER

Gilberto DALMASO / VELTEK ASSOCIATES

Susana LÓPEZ HERNÁNDEZ / AEMPS (Ph. Eur.)

Victoria NAVARRO / PFIZER

Beatriz ROQUÉS / REIG JOFRE

Our partners will offer you 3 sessions of workshops

Workshops ◊ Session 1 ◊ 12.30 pm
Partners
Update on the use of recombinant cascade reagents in BET – focus on equivalency
Salvador GARRIDO
Associates of
Cape Cod
Optimize in process control and final product performances with rapid microbiological methods
Guillaume Devun & Pilar Rubio
bioMérieux
Harmonizing Rapid Detection of Microbial Contamination Across the Biomanufacturing Process
Lucia Ceresa
Charles River
Annex 1 in The Age of Digitization: Reimagining Contamination Control
Marc VORDERMAN
Novatek Int.
Maximizing Product Sterility Assurance: Component Preparation and Wrapping
Renée Buthe
Steris
Workshops ◊ Session 2 ◊ 02.45 pm
Partners
Investigating poor repeatability in BET – why are my CVs so high?
David GUY
Associates
of Cape Cod
The future of Environmental monitoring
Marion Louis & Pilar Rubio
bioMérieux
Rapid Microbial Method Validation: How to Commit the Regulatory Expectation for Specificity
Lucia Ceresa
Charles River
Annex 1 in The Age of Digitization: Reimagining Contamination Control
Marc VORDERMAN
Novatek Int.
Maximizing Product Sterility Assurance: Component Preparation and Wrapping
Renée Buthe
Steris
Workshop ◊ Session 3 ◊ 03:45 pm
Partners
Update on the use of recombinant cascade reagents in BET – focus on equivalency
Salvador GARRIDO
Associates of
Cape Cod
Optimize in process control and final product performances with rapid microbiological methods
Guillaume Devun & Pilar Rubio
bioMérieux
Detección temprana de biofilm por tecnología de cartuchos
Anna ROCA
Charles River
Annex 1 in The Age of Digitization: Reimagining Contamination Control
Marc VORDERMAN
Novatek Int.
Maximizing Product Sterility Assurance: Component Preparation and Wrapping
Renée Buthe
Steris

Registration Form

Become A3P member and participate in A3P Microbiology event.

Price: 500€ (+membership up to date)

Forum A3P Microbiology – April 7th, 2022 in MADRID

The exhibition is full

CompanyStand n°CompanyStand n°
LOGOS BIOSYSTEMS1RAPID MICRO BIOSYSTEMS9
INSTRUMENTACIÓN ANALÍTICA2NOVATEK INTERNATIONAL10
MERCK3BIOMERIEUX11
TISELAB4STERIS12
CHARLES RIVER5ASSOCIATES OF CAPE COD13
BECTON DICKINSON6CONFARMA14
MESALABS7BWT15
VELTEK ASSOCIATES Inc.8

Services included with the Table Top stand

  • A dedicated exhibition area where you can install your products and communication tools: umbrella stand, roll-up, display, product, …
    A basic equipment including a 180×80 cm table, 2 chairs and 1 electrical connection (2kw) without circuit breaker
  • Breaks and meals as indicated in the program
  • Illimited Wifi
  • A badge that gives you free access to the entire technical and scientific programme.
  • The list of participants to the event

Contact

Depending on your requirements and preferences, you can contact Florian Canuto:

Phone number: +33 (0)7 61 55 24 36

Email : fcanuto@a3pservices.com

Accessibility :