Pharma Microbiology Congress 2024

In the opening session of the congress, the general themes currently emerging in the regulatory landscape of sterile manufacturing and the prospects in the sterile pharmaceuticals market will be addressed. Experts from regulatory and industry backgrounds will deliver technical speeches and engage in a fruitful roundtable discussion.

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

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

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

9.50 – Continual Improvement in Sterile Manufacturing – Risk based high level QRM approach
Rainer Gnibl, Government of Upper Bavaria, Head of Inspectorate

10.15 – Round Table – Facing the future of sterile medicines in the EU landscape
Moderator: G. Gori
Participants:
M. Delbò, Former Head of the Italian GMP Inspectorate
R. Kumoluyi, Former Vice President & Chief Quality Officer | J&J Innovative Medicine
A. Moon, Director of AM GMP Limited and former Lead Senior GMDP Inspector | MHRA
R. Gnibl, Government of Upper Bavaria, Head of Inspectorate

10.45 – Coffee Break

The highly acclaimed session on cutting-edge technologies, featured in the plenary agenda, includes a selection of engaging webinars focused on the innovation. This format allows for full interaction with the experts.

11.00 – Introduction
Silvia Calloni, Events & Sponsorship | Pharma Education Center

11.05 – 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

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

The session faces the topic of QRM by exploring different perspectives and application areas of this important paradigm in the pharmaceutical world. In this session, intere sting case studies and in-depth interventions will be presented.

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

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

12.00 – 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

12.20 – 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

12.45 – Round Table
Moderator: J. Drinkwater
Participants: D. Calzolari, A. Ruiz Mahillo, T. Moore, A. Petrigliano

1.15 – Lunch

The highly acclaimed session on cutting-edge technologies, featured in the plenary agenda, includes a selection of engaging webinars focused on the innovation. This format allows for full interaction with the experts.

2.00 – Introduction
Silvia Calloni, Events & Sponsorship | Pharma Education Center

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

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

The session offers interesting case studies and technical speeches by experts from the pharma companies and representatives of innovative technologies, aimed at sharing advanced practical experiences on environmental control and process monitoring. The importance of adequately identifying the type of contaminant to determine the root cause and to define respective remediation measures will also be highlighted.

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

2.55 – Tim Sandle, Pharmaceutical Microbiologist & Contamination Control Expert | Bio Product Laboratory Limited

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

3.35 – 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

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

4.15 – Round Table
Moderator: F. Boschi
Participants: O. Degen, P. Merker, T. Sandle, F. Van Der Zanden

4.45 – 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

5.15 – Closure of day one
Lucia Costanzo, Pharma Microbiology Congress Chairperson

The session offers an overview of regulatory trends and emerging technologies in microbiological control, including alternative or rapid methods. It aims to explore regulatory updates, validation approaches, and technological applications, reflecting on the “microbiological tests of the future.”

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

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

9.30 – 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.

9.50 – Realtime Microbiological Quality Control online of  Water forPharma production (Bioburden, Purified andWFI)
Wolfgang Vogl, CEO-Founder | VWMs GmbH

10.10 – Q&A Time
Moderator: L. Ceresa
Participants: W. Vogl, Elena Secchi and Mattew Stevenson | Associates of Cape Cod, Inc.

10.30 – Coffee break

The highly acclaimed session on cutting-edge technologies, featured in the plenary agenda, includes a selection of engaging webinars focused on the innovation. This format allows for full interaction with the experts.

10.50 – Introduction
Silvia Calloni, Events & Sponsorship | Pharma Education Center

10.55 – Ral-time management of in-line water microbiological quality: Advantages and Benefits
Wolfgang Vogl, CEO-Founder | VWMs GmbH

The Annex 1 requirements have brought about a significant impact on the implementation of the latest technological advancements, including the adoption of automatic or semi-automatic loading/unloading systems in conjunction with barrier technologies. This will herald a revolution in the processes surrounding lyophilization, affecting equipment,
processes, and methods, with various implications for organization and production. The session will delve into the technical and regulatory aspects of this important technology with the help of interesting case studies.

11.20 – Requirements for lyophilization in the new EU GMP Annex 1
Marisa Delbò, (Chaiperson & Speaker), Former Head of the Italian GMP Inspectorate and of GMP API Inspection and Manufacturing Authorization Office

11.50 – 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

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

12.30 – Round Table
Moderator: M. Delbò
Participants: M.Conti, S. Penazzi, F. Trionfera, Quality Operation Manager & QP | BSP Pharmaceuticals

1.00 – Lunch

The highly acclaimed session on cutting-edge technologies, featured in the plenary agenda, includes a selection of engaging webinars focused on the innovation. This format allows for full interaction with the experts.

2.00 – Introduction
Silvia Calloni, Events & Sponsorship | Pharma Education Center

2.05 – Benefits of an automated filtration and filling system to accurately fill your bulk product in bags or bottles
Natasha Kelly, Scientific Knowledge Manager, Scientific Laboratory Services

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

2.25 – MeCo solutions – Sterilization in place and biological validation: concerns and solutions
Karen Kesley, Product & Application Specialist | MesaLabs

2.25 – Wipes for Cleanrooms – is there a sustainable option ?
Karen Rossington, EMEA Technical Marketing Manager | Contec Inc

This session explores the future perspectives of pivotal regulatory and technological aspects of Barrier systems, highlighting the latest advancements in automation and robotics technologies. The final roundtable, facilitated by experts, fosters engagement and interaction with attendees.

2.45 – Introduction
Patrizia Muscas, Sterility Assurance Director, Global TS.MS | Eli Lilly and Company

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

3.15 – Gloveless robotic systems meet Annex 1 – Benefits, challenges and lessons learned from an end user perspective.
Thorsten Haefner, VP Business Development of PSM – Your Pharma CDMO

3.35 – Q&A Time
Moderator: P. Muscas
Participants: B. Lieffers, T. Haefner

3.55 – Coffee Break

Disinfection can seem like a never-ending race against microorganisms, but with appropriate cleaning, disinfection, sterilization practices, and innovative technologies, these objectives can be achieved. During this section, technical presentations will explore regulatory trends, technological innovations and best practices in sterilization, cleaning and disinfection. The aim is to develop a robust, science-based cleaning and disinfection program for success.

4.10 – Chairperson PEC

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

4.40 – 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

5.00 – Case Study: Validation of disinfectants on cleanroom surfaces
Karen Rossington | Contec Inc

5.20 – 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

5.40 – Round Table
Moderator: Chairperson PEC
Participants: P. Chandra Das, J. Drinkwater, D. Lanzon, K. Rossington

6.10 – Closure of the second day
Lucia Costanzo, Senior Conference Manager | PEC & Pharma Microbiology Congress Chairperson

8.30 – WELCOME COFFEE and registration of attendees
The opening session of the last day of the conference in Florence gives the floor to representatives from the Italian and European regulatory agencies, addressing the delicate topic of innovation drive and regulatory compliance. Expert industry speakers will complete the session with a final roundtable discussion involving the audience.

9.20 – Lucia Costanzo, Senior Conference Manager | PEC & Pharma Microbiology Congress Chairperson

9.30 – GMP Senior Inspector AIFA (tbc)

9.55 – New findings in GMP inspections since new GMP Annex 1 implementation. How the industry and NCA inspectors’ bodies can collaborate for a quick implementation and adherence to the new principles. Examples from national and international inspections.
Jesus Chesa Jiménez, Head of GMP Inspection Area, Inspection Area Pharmaceutical Inspection and Enforcement Department | AEMPS

10.20 – Round Table- Lead the compliance and speed the innovation in the future of sterile manufacturing
Moderator: A. Moon, Director of AM GMP Limited and former Lead Senior GMDP Inspector | MHRA
Participants:
GMP Senior Inspector AIFA (tbc)
J. Chesa, Head of GMP Inspection Area | AEMPS
G. Gori, Quality Consultant, Science Advisory Board Chair | PDA
J. Drinkwater, Head of PHSS Aseptic Processing and Containment Special Interest Group
T. Moore, Founder and CEO | TM Pharma Group Ltd and former MHRA Expert EU GMDP Inspector

10.50 – Coffee Break

This session is dedicated to exploring two key themes in Sterility Assurance: Low Endotoxin Recovery studies and emerging technologies supporting the visual inspection of Media Fill. Experts will answer audience questions in the Q&A session.

11.20 – Introduction
Silvia Calloni, Events & Sponsorship | Pharma Education Center

11.25 – Key Considerations for LER Hold Time Studies
Alessandro Pauletto, Global LER Business Manager | bioMérieux

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

12.05 – Q&A time

In this session, the theme of digitalization is explored through two insightful presentations by experts, aiming to highlight the potential of the digital revolution in pharmaceutical microbiology and its practical applications. The subsequent Q&A session will provide an opportunity for interaction, allowing participants to pose questions to the experts.

12.15 – Introduction
Silvia Calloni, Events & Sponsorship | Pharma Education Center

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

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

1.00 – Q&A time

After lunch, attendees can visit the exclusive area of Palazzo degli Affari, where the numerous technology exhibitors will be present. This provides an opportunity to delve into the technologies and engage in networking.

The last technical session of the congress day is dedicated to showcasing innovative case studies and inspirational technical speeches. Representatives from the invited companies will share their experiences, challenges, and outcomes in implementing innovative systems and organizational models related to drug control and production.You will be invited
to participate by asking questions during the final Q&A session.

3.00 – Introduction
Ferrazin Fernanda, (Chair of the Session), Life Sciences Expert, Former GMP Inspector | AIFA

3.10 – 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

3.35 – 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

4.00 – Q&A Time
Moderator: F. Ferrazin
Participants: A. Leszczynska, C. Nitu, A. Ruiz Mahillo

4.15 – OPEN EXHIBITION & NETWORKING TIME
WHERE? In the Exhibition Area, at the first floor in Palazzo degli Affari
WHEN? From 4.15 to 6.00 pm
TYPE ON EXHIBITION? Open access also for external companies
WHO? 20 EXIBITORS
WHAT? Technical presentations, demonstrations, videos, showcase
WHY ATTEND? To discover the scientific potential of the new technologies and engage with experts

In the exclusive area of the Palazzo degli Affari, the numerous exhibitors of technologies will showcase techno logical innovations through videos and demonstrations.
The exhibition area will be open from 4:30 pm onwards for all attendees, and representatives of non-registered companies are welcome to visit with free admission.