Pharma Microbiology Congress 2024

28-29 Ottobre 2024
Online
English
 
8 Novembre 2024
Face-to-face in Florence, Italy
English
 

Panoramica della conferenza

STRATEGIES AND INNOVATION TECHNOLOGIES IN STERILE MANUFACTURING

The Pharma Microbiology Congress is the European annual meeting point of professionals involved in the sterile manufacturing of medicinal products and medical device.

A full immersion on the latest regulatory updates, new technologies for the detection and containment of contamination, best practice and strategies to improve the sterility assurance of the manufacturing and control of sterile medicines.

Professionals belonging to different areas of expertise (Production, Engineering, Quality Control, Quality Assurance, R&D, Maintenance) will get together to share and discuss the hottest topics with experts coming from Regulatory Bodies, Pharmaceutical Companies, Consultancy, Associations and New Technologies providers.

The program will see the contribution of International Top Speakers as experts, key opinion leaders and representatives of institutions.

Road to Pharma Microbiology Congress 2024 - IN PROGRESS

FOLLOW THE ROAD TO PMC 2024
The initiative will see us and the sponsors working in synergy, before the conference, by organizing a series of thematic webinars and interviews.

Subscribe to the official LinkedIn page and don’t miss them!

Format del congresso

VIRTUAL + FACE TO FACE

Last year the mixed format reached a great success, so this year as well the first two days, October 28th and 29th, will be virtual and will see the participation of worldwide experts and key opinion leaders.

The third day, November 8thwill be a face-to-face meeting in Florence, where you will have the chance to meet colleagues and the speakers of the conference: a great opportunity for the sterile manufacturing community to get together!

Perchè partecipare?

EXPERTS & KOLs OF THE FIELD WILL SHARE THEIR EXPERIENCES AND KNOW HOW:
From regulatory issues to the most technical aspects, our speakers will share their deep expertise with the audience through speeches, round tables and question times: ask questions, rate the ones coming from the audience and let us know what is important for you to know.

STAY UPDATED ON THE LATEST TECHNOLOGIES AND TECHNOLOGICAL ADVANCES
Each day, a session dedicated to new technologies and technological advances that are changing the world of sterile manufacturing. Don’t miss webinars, interviews and demonstrations, and chat with real experts of the field!

A chi è rivolto?

The event is aimed specifically at PharmaBiotech and Medical Device CompaniesRegulatory bodies and Technology Suppliers involved in the manufacturing and control of Sterile medicines.

Featured Topics

In progress…

28 Ottobre 2024 - Virtual


Session I - Facing the Future of Sterile Medicines in the EU Landscape

Lucia Costanzo, Senior Conference Manager | PEC & Pharma Microbiology Congress chairperson

Gabriele Gori (Chair of the Session,) Quality Consultant, Science Advisory Board Chair | PDA

Evolution of sterile medicines and future challenges
Robin Kumoluyi, Vice President & Chief Quality Officer | J&J Innovative Medicine

Alan Moon, Director of AM GMP Limited and former Lead Senior GMDP Inspector | MHRA

Regulatory Body and Pharma Representatives (invited)

Session II - WEBINARS: Discovering Cutting-edge Technologies

QC lab of the future with the Growth Direct® System: Automated incubation & colony counting combined with a paperless workflow
Johannes Oberdörfer, Field Application Scientist | Rapid Micro Biosystems

IR Biotyper: a new approch for Environmental Monitoring
Matteo Viganó, European Food & Industry Microbiology Sales Representative | Bruker Microbiology & Infection Diagnostics

Session III - QRM: Evolution & Revolution in Sterile Manufacturing

James Drinkwater (Chairperson), Head of PHSS Aseptic processing and Containment Special Interest Group and Franz Ziel Head of GMP compliance and Aseptic Processing support

QRM: EVOLUTION & REVOLUTION of the PQS and CCS
Tracy Moore, Founder and CEO | TM Pharma Group Ltd and former MHRA Expert EU GMDP Inspector

Integrating and Tailoring Quality Risks Management in the Pharmaceutical Quality System: A Collaborative tool approach.
Alicia Ruiz Mahillo, Group Quality Microbiology and Sterility Assurance Manager | FAMAR

Occupancy and Gowning: QRM Strategies for Revolutionizing Personnel Risk
Angela Petrigliano, Quality & Process Operations Manager | Pharma D&S a Product Life Group Company

Daniele Calzolari, Quality & Process Team Leader Senior Consultant | Pharma D&S a Product Life Group Company

Session IV - WEBINARS: Discovering Cutting-Edge Technologies

AIs with eyes: How to make things that count
Daniele Maffi, Software Engineer | Copan Group

VITEK MS PRIME: a microbial identification solution to meet Annex 1 requirements
Adam Azoud, Global Solution Manager | BioMérieux

Session V - Advancements in Process & Environmental Monitoring

Francesco Boschi (Chairperson of the Session), Sr. Manager Technical Services – Global Microbiology and Aseptic Support Team (MAS) | Pfizer

Quality Risk Management and Implementation of Continuous Real-Time Environmental Monitoring in Aseptic Processing
Petra Merker, Manager – Biological Quality Control | Bayer AG

Holistic approach to Microbial ID program – risks of inaccurate IDs
Frank van der Zanden, Ceo of Sure Laboratories and Chairman of the Dutch Commission 370216 Disinfectants and antiseptics

Innovative Technology applied to RCA of a microbial investigation
Olaf Degen, Director Industry Microbiology | Bruker Microbiology & Infection Diagnostics

Lectio Magistralis

A Roadmap to a Successful Cleaning and Disinfection Program that Meets Annex I Guidance
Jim Polarine, Renowned pharmaceutical microbiology expert, PDA’s Scientific Advisory Board member

29 ottobre 2024 - Virtual


Session VI - Alternatives/Rapid Methods: Regulatory trends and advancements for reliable sterility assurance

Rapid Microbial Methods: a long journey between challenges and real implementation.
Lucia Ceresa, (Chairperson & Speaker), Pharmaceutical Consultant – PDA Italy Chapter Board

Regulatory Updates in Recombinant Technologies for Bacterial Endotoxin Testing: Understanding the upcoming USP Chapter <86> and its implications for European manufacturers.
Veronika Wills, Associate Director, Global Technical Services | Associates of Cape Cod, Inc.

Realtime Microbiological Quality Control online of  Water for Pharma production (Bioburden, Purified and WFI)
Wolfgang Vogl, CEO-Founder | VWMs GmbH

Session VII - WEBINARS: Discovering Cutting-Edge Technologies

Speakers 2024 in progress

Session VIII - Barrier systems, automation & robotics: present and future

Patrizia Muscas, (Chairperson of the session) Sterility Assurance Director, Global TS.MS | Eli Lilly and Company

Closed, gloveless isolators for Clinical and Commercial Drug Products
Brent Lieffers, Innovation Advocacy Leader, Aseptic Filling, Quality and Regulatory Affairs | Cytiva

Session IX - Discovering Cutting-Edge Technologies

Benefits of an automated filtration and filling system to accurately fill your bulk product in bags or bottles
Brent Lieffers, Innovation Advocacy Leader, Aseptic Filling , Quality and Regulatory Affairs | Cytiva

Recombinant Cascade Reagent – The Future of Endotoxin Testing
Matthew Stevenson, European Sales Manager | Associates of Cape Cod, Inc.

MeCo “Round” and MeCo “Flat” – Sterilization in place and biological validation: concerns and solutions
Luisa Bernuzzi, SDC Life Science | Mesa Laboratories, Inc.

Session X - Lyophilization: Meeting the needs of a changing landscape

Introduction
Marisa Delbò, (Chaiperson & Speaker), Former Head of the Italian GMP Inspectorate and of GMP API Inspection and Manufacturing Authorization Office

How to reach the Annex 1 compliance for existing freeze dryers: case studies on sterile bulk products and filled vials
Marco Conti, CEO | C&P Engineering, a Product Life Group Company

Lyophilization product transfer vs Annex 1
Simone Penazzi, Business Development Manager | QS Group Srl

Session XI - Sterilization, Cleaning & Disinfection: Current Industry Trends and Regulatory Expectations

Regulatory Landscape 2024: Navigating New Standards in Sterilization and Disinfection
Palash Chandra Das, Sterility Assurance Expert | PRES

Case Study: Disinfection Qualification Global Program , a practical approach to provide harmonization and simplification
Daniel Lanzon, Senior Manager, Microbiology and Aseptic Support (MAS) | Pfizer Global Supply, Global Quality Technical Operations, Perth Australia

Case Study: Validation of disinfectants on cleanroom surfaces
Karen Rossington, EMEA Technical Marketing Manager | Contec Inc

Strengths of Hydrogen Peroxide vapour Bio-decontamination and advanced cycle development
James Drinkwater, Head of PHSS Aseptic Processing and Containment Special Interest Group and Franz Ziel Head of GMP compliance and Aseptic Processing support

8 Novembre 2024 - Face-to-face: Firenze, Italia


Session XII - Regulatory Bodies: Lead the Compliance & Speed the Innovation in the Future of Sterile Manufacturing

Italian and European Regulatory Bodies representatives (invited)

Pharma Companies representatives

Session XIII - Cutting-Edge Technologies in Sterile Production & Control

Good practice in LER study: the choice of the endotoxin
Alessandro Pauletto, Global LER Business Manager | bioMérieux

A Science-Based Approach to APS: Using Headspace Analysis for Automated Analytical Media Fill Inspection
Suzanne Kuiper, Application Manager | Lighthouse Instruments

Session XIV - The Digital Age: Application in Microbiology

Embracing Digitalisation & Pharma 4.0: Innovations Shaping the Future of Pharmaceutical manufacturing
Johannes Oberdörfer, Field Application Scientist | Rapid Micro Biosystems

Optimizing environmental monitoring with automation and A.I.
Nicole Schepis, Senior Laboratory Product Validation Specialist | Copan Group

Session XV - Lunch & Visit to the Technology Exhibition

Speakers 2024 in progress

Sessione XVI - Navigating the future: Innovation Models in Manufacturing & Controls

Ferrazin Fernanda, (Chairperson of the Session), Life Sciences Expert, Former GMP Inspector | AIFA

Case study 1: Towards a Paperless Future: Navigating the Transition in Quality Control Labs
Aneta Leszczynska, QC Microbiology Scientist | Biogen Corina Nitu, QC Microbiology Associate | Biogen

Case study 2: Sterile Pharma Manufacturing 4.0: Virtual Reality and Artificial Intelligence, a practical approach and considerations for implementation in Sterile Manufacturing
Alicia Ruiz Mahillo, Group Quality Microbiology and Sterility Assurance Manager | COMPASS by FAMAR

Open Exhibition & Networking Time

Speakers 2024 in progress

SPEAKERS 2024 IN PROGRESS


Gabriele Gori

Gabriele Gori

Quality Consultant, Science Advisory Board Chair | PDA

Francesco Boschi

Francesco Boschi

Senior Manager Technical Services QTO Sterile Injectables & Biotech | Pfizer Global Supply

Angela Petrigliano

Angela Petrigliano

Quality & Process Operations Manager | Pharma D&S, A Product Life Group

Tracy Moore

Tracy Moore

Director | TM Pharma Group Ltd and former MHRA Expert EU GMDP inspector

Fernanda Ferrazin

Fernanda Ferrazin

Life Sciences Expert, Former GMP Inspector | AIFA

Patrizia Muscas

Patrizia Muscas

Sterility Assurance Sr Research Scientist Global TS.MS | Eli Lilly and Company

James Drinkwater

James Drinkwater

Head of PHSS Aseptic Processing and Containment Special Interest Group and Franz Ziel Head of GMP compliance and Aseptic Processing support

Lucia Ceresa

Lucia Ceresa

Pharmaceutical Consultant | PDA Italy Chapter Board

Jim Polarine

Jim Polarine

Renowned pharmaceutical microbiology expert, PDA’s Scientific Advisory Board member

Alan Moon

Alan Moon

Director of AM GMP Limited and former Lead Senior GMDP Inspector |MHRA

Marco Conti

Marco Conti

CEO | C&P Engineering, a Product Life Group Company

Robin Kumoluyi

Robin Kumoluyi

Vice President & Chief Quality Officer | J&J Innovative Medicine

Marisa Delbò

Marisa Delbò

Former Head of the Italian GMP Inspectorate and of GMP API Inspection and Manufacturing

Aneta Leszczynsk

Aneta Leszczynsk

QC Microbiology Scientist | Biogen

Susanne Kuiper

Susanne Kuiper

Application Manager | Lighthouse Instruments

Tim Sandle

Tim Sandle

Pharmaceutical Microbiologist & Contamination Control Expert | Bio Product Laboratory Limited

Corina Nitu

Corina Nitu

QC Microbiology Associate | Biogen

Johannes Oberdörfer

Johannes Oberdörfer

Field Application Scientist | Rapid Micro Biosystems

Alessandro Pauletto

Alessandro Pauletto

Sales and Tech Support in Pharma Industry – Global LER Business Development Manager | bioMérieux

Palash Chandra Das

Palash Chandra Das

Sterility Assurance Expert | PRES

Alicia Ruiz Mahillo

Alicia Ruiz Mahillo

Group Quality Microbiology and Sterility Assurance Manager | COMPASS by FAMAR

Nicole Schepis

Nicole Schepis

Senior Laboratory Product Validation Specialist | Copan Group

Frank Van der Zanden

Frank Van der Zanden

Ceo of Sure Laboratories and Chairman of the Dutch Commission 370216 Disinfectants and antiseptics

Veronika S. Wills

Veronika S. Wills

Associate Director, Global Technical Services | Associates of Cape Cod, Inc.

Wolfang Vogl

Wolfang Vogl

CEO-Founder | VWMs GmbH

Petra Merker

Petra Merker

Manager – Biological Quality Control | Bayer AG

Olaf Degen

Olaf Degen

Director Industry Microbiology |Bruker Microbiology & Infection Diagnostics

Adam Azoud

Adam Azoud

Global Solution Manager | bioMérieux

Daniele Maffi

Daniele Maffi

Software Engineer | Copan Group

Matthew Stevenson

Matthew Stevenson

European Sales Manager | Associates of Cape Cod, Inc.

Matteo Viganó

Matteo Viganó

European Food & Industry Microbiology Sales Representative | Bruker Microbiology & Infection Diagnostics

Brent Lieffers

Brent Lieffers

Innovation Advocacy Leader, Aseptic Filling, Quality and Regulatory Affairs | Cytiva

Simone Penazzi

Simone Penazzi

Business Development Manager | QS Group Srl

Daniele Calzolari

Daniele Calzolari

Quality & Process Team Leader Senior Consultant | Pharma D&S, a ProductLife Group Company

Karen Rossington

Karen Rossington

EMEA Technical Marketing Manager | Contec Inc

Daniel Lanzon

Daniel Lanzon

Senior Manager, Microbiology and Aseptic Support (MAS) | Pfizer Global Supply, Global Quality Technical Operations, Perth Australia

SPONSORS 2024 IN PROGRESS

Associates of Cape Cod, Inc.

Silver Sponsor
Associates of Cape Cod, Inc.

BioItalia

Silver Sponsor
BioItalia

BioMérieux

Gold Sponsor
BioMérieux

BD

Exhibitor
BD

Bruker

Silver Sponsor
Bruker

C&P Engineering

Silver Sponsor
C&P Engineering

Charles River

Silver Sponsor
Charles River

Copan

Gold Sponsor
Copan

Cytiva | Pall

Silver Sponsor
Cytiva | Pall

Euroclone

Exhibitor
Euroclone

Lighthouse

Gold Sponsor
Lighthouse

Mesa Labs

Exhibitor
Mesa Labs

Pharma D&S

Silver Sponsor
Pharma D&S

QS Group

Silver Sponsor
QS Group

Rapid Micro Biosystems

Gold Sponsor
Rapid Micro Biosystems

RIGEL

Exhibitor
RIGEL

Veltek

Exhibitor
Veltek

Vileda

Exhibitor
Vileda

Rapid Microbiology

Media Partner
Rapid Microbiology

Contec

Silver Sponsor
Contec

Diventa sponsor

The Pharma Microbiology Congress 2024 provides an excellent opportunity to get in touch with microbiology/sterility assurance professionals and decision makers. To sponsor the event, contact us!

Sede del congresso

The Pharma Microbiology Congress 2024 will be a mixed event:

Step 1
On October 28-29 the event will be VIRTUAL to grant you the possibility of joining the conference even from your office or home, wherever you may be.
We have organized a true virtual location, a space where you will be able to:

  • Follow the live streaming of the congress, listen to experts and opinion makers and be informed about latest trends and technological breakthroughs in sterile manufacturing
  • Visit the VIRTUAL EXHIBITION AREA and all the stands of our sponsors
  • Join Q&A times and round tables to discuss the current hot topics in the field
  • Chat with our sponsors and learn about new technologies and services to ease your daily work and increase the performance

Step 2
Let’s finally meet face to face in Florence on November 8! A great chance to meet in person the PMC experts and colleagues. The conference will be hosted in the wonderful spaces of Palazzo degli Affari, right in the heart of Florence.

Edizioni precedenti

Scarica le brochure delle precedenti edizioni di Pharma Microbiology Congress 2024

Iscriviti alla conferenza

Face to Face (8/11/24)
Early bird fino al 28/09/2024*

400€
500€

Virtual (28-29/10/24)
Early bird fino al 28/09/2024*

750€
800€

Virtual + Face to Face (28-29/10/24 e 8/11/24)
Early bird fino al 28/09/2024*

1100€
1200€

* Ospedali, università e liberi professionisti ottengono uno sconto del 40% da applicare ai prezzi pubblicati (gli sconti non sono cumulabili).

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