PDA Good Aseptic Manufacturing Conference 2024

Assessing EU GMP Annex 1: 264 Days into the Journey

Stuttgart, Germany
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Program Highlights

The agenda is out now!

Related PDA Letter Article: Elevating Sterile Manufacturing authored by our Co-Chair, Simone Biel, Merck.

Dear Colleague,

We are thrilled to announce the upcoming PDA Good Aseptic Manufacturing Conference 2024 scheduled to take place on 15-16 May 2024 in Stuttgart, Germany.

This year's conference will revolve around the theme Assessing EU GMP Annex 1: 264 days into the journey, providing a valuable platform to assess our experiences, identify gaps, process challenges, and explore unresolved questions.

Together, we will delve into the impact of this regulatory change, discussing its implications, but also opportunities for the aseptic manufacturing industry. Our primary objective is to facilitate open and constructive discussions among manufacturers, regulators, and experts from various fields. By sharing our experiences and insights, we aim to collectively address the remaining uncertainties and pave the way for further progress in this critical area.

In addition to evaluating the current situation, we want to encourage forward-thinking and explore future disruptive technologies. Let us collectively imagine a world where risks are minimized to the greatest extent possible. Together, we can shape the future of aseptic manufacturing and contribute to safer products for patients worldwide.

We cordially invite you to be a part of this exceptional event, joining us in Stuttgart for two days of in-depth discussions, networking opportunities, and knowledge exchange. Together, we can create a collaborative and inspiring atmosphere that fosters innovation and drives the industry forward.

Following the conference an additional optional site visit at the Syntegon facility will take place on 17 May 2024 in Crailsheim, Germany.

Save the dates for the PDA Good Aseptic Manufacturing Conference 2024 and make sure to register. We look forward to your participation and to welcoming you to Stuttgart in May 2024.

Sincerely,

The Co-Chairs

Simone Biel, Merck
Darren Beckett, Fedegari

SCIENTIFIC PROGRAM PLANNING COMMITTEE:

  • Simone Biel, Merck
  • Darren Beckett, Fedegari
  • Richard Denk, SKAN
  • Paul Devuyst, GSK
  • Rainer Glöckler, ten23 health
  • David Keen, Ecolab
  • Hue Kwon, GLS Advisors
  • Peter Makowenskyj, GCon Bio
  • Christina Meissner, AGES
  • Tracy Moore, TM Pharma Group
  • Andrea Salmaso, Stevanato Group
  • Helen Sauter, Vetter Pharma
  • Klaus Ullherr, Syntegon
  • Jessie Lindner, PDA
  • Falk Klar, PDA Europe
  • Caroline Lynar, Manager Programs & Events, PDA Europe
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Standard Registration

Member Price

€ 2.250

GovernmentMember Only

€ 1.080

Health AuthorityMember Only

€ 1.080

Early Career ProfessionalMember Only

€ 1.080

StudentMember Only

€ 1.080

AcademicMember Only

€ 1.080

Non-Member

€ 2.550

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Wednesday, 15 May CEST

  • Registration Open

    Saal MARITIM & Lobby Empore

  • Welcome and Introduction

    Alte Stuttgarter Reithalle

    • Committee Member: Falk Klar, PhD, Parenteral Drug Association

    Plenary
  • Welcome from the Co-Chairs

    Alte Stuttgarter Reithalle

    • Co-Chair: Simone Biel, PhD, Senior Regulatory Consultant, Merck

    • Co-Chair: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

    Plenary
  • Opening Plenary Part I: Advancing Aseptic Manufacturing for Safe Medicines - Lessons Learned and Path Forward

    Alte Stuttgarter Reithalle

    • Moderator: Simone Biel, PhD, Senior Regulatory Consultant, Merck

    Through insightful keynote presentations, interactive discussions, and case studies, participants will explore the challenges and achievements in EU GMP Annex 1 implementation. Join us for this thought-provoking session as we collectively reflect on the progress made thus far, identify areas for improvement, and lay the groundwork for a harmonized approach to aseptic manufacturing that ensures the continued delivery of safe medicines to patients worldwide.
    Plenary
    • Keynote: Empowering Patients Through Good Aseptic Manufacturing: A Vital Journey Towards Safer Medical Products

      • Presenter: Hussain Jafri, PhD, Executive Director , World Patients Alliance

    • Fit for Future: Sterile Manufacture? A Personal View on Revised EU GMP Annex 1

      • Regulatory Presenter: Daniel Mueller, PhD, Head of GMDP-Inspectorate, Regierungspraesidium Tuebingen, Germany

    • Implementation of EU GMP Annex 1 – Inspection Experiences and Expectations

      • Regulatory Presenter: Christina Meissner, AGES - Austrian Agency for Health and Food Safety

  • Networking Coffee Break, Poster Session & Exhibition

    Saal MARITIM & Lobby Empore

  • Opening Plenary Part II: Advancing Aseptic Manufacturing for Safe Medicines - Lessons Learned and Path Forward

    Alte Stuttgarter Reithalle

    • Moderator: Simone Biel, PhD, Senior Regulatory Consultant, Merck

    Through insightful keynote presentations, interactive discussions, and case studies, participants will explore the challenges and achievements in Annex 1 implementation. Join us for this thought-provoking session as we collectively reflect on the progress made thus far, identify areas for improvement, and lay the groundwork for a harmonized approach to aseptic manufacturing that ensures the continued delivery of safe medicines to patients worldwide.
    Plenary
    • The Evolution of the Contamination Control Strategy from Concept/Conversion to Continuous Improvement

      • Presenter: Tracy Moore, Director, TM Pharma Group Ltd

    • EU GMP Annex 1 Implementation: A Case Study of the Sterile Production at F. Hoffmann-La Roche Ltd.

    • Interactive Questionnaire Session

    • Plenary Discussion

      • Moderator: Simone Biel, PhD, Senior Regulatory Consultant, Merck

      • Moderator: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

      • Panelist: Hussain Jafri, PhD, Executive Director , World Patients Alliance

      • Panelist: Tarik Cheema, PhD, End to End Contamination Control Manager, F. Hoffmann-La Roche AG

      • Panelist: Tracy Moore, Director, TM Pharma Group Ltd

      • Panelist: Christina Meissner, AGES - Austrian Agency for Health and Food Safety

      • Panelist: Daniel Mueller, PhD, Head of GMDP-Inspectorate, Regierungspraesidium Tuebingen, Germany

      • Panelist: Marisa Delbo, PharmD, Consultant , NA

  • Networking Lunch Break & Exhibition

    Saal MARITIM & Lobby Empore

  • Guided Poster Walk

    Lobby Empore

    Poster Presentation
    • Biodecontamination of Raw Materials in Packaging Production Process

    • CFD - Computational Fluid Dynamics for Airflow Visualization Studies

      • Poster Presenter: Christian Scarpato, Process Engineering Manager, Merck

    • eBeam Technology – Transfer Technology for Pre-Sterilized RTU Components

      • Poster Presenter: Manfred Holzer, Strategic Product Manager E-Beam Technology, SKAN AG

    • Environmental Monitoring in LIMS

      • Poster Presenter: Julia Wiesner, PhD, Senior Director, Head of QC & QA Systems, Merz Pharma GmbH & Co. KGaA

    • Far UV-C Light - Safe and Effective Decontamination

    • Headspace Analysis as Innovative Method for Media Fill Inspection

      • Poster Presenter: Michael Mettraux, MSc ETH, Development Engineer, WILCO AG

    • Particle Loss in Transport Tubing: How to Address the New Annex 1 Requirement

      • Poster Presenter: Serena Steidl, MD, EMEA Advisory Project Coordinator - Advisory Specialist , Particle Measuring Systems

    • Rapid Sterility Testing as the Critical and Final Result for Product Release - Design Verification (DV) Data

      • Poster Presenter: Johannes Oberdörfer, B.Sc, Field Application Scientist, Rapid Micro Biosystems

    • Reducing Glove Intervention in Fill & Finish Process

    • The Need for High Quality in Primary Packaging

      • Poster Presenter: Ana Kuschel, PhD, Principal Scientific Affairs, West Pharmaceutical Services, Inc.

      • Poster Presenter: Niamh Bissett

    • Trending and Pattern Recognition for Annex1

      • Poster Presenter: Susan B. Cleary, B.CS, EMBA, Director Product Development, Novatek

    • VHP Uptake of Manufacturing Tubing Used for Aseptic Fill-Finish Processes of Biopharmaceutical Drug Products

      • Poster Presenter: Dilara Ali, MSc, PhD Student , ten23 health

  • Session 1, Track A: Impact of EU GMP Annex 1 on Lyophilization

    Alte Stuttgarter Reithalle

    • Moderator: Andrea Salmaso, PharmD, Corporate Regulatory and Scientific Affairs Manager, Stevanato Group

    The new EU GMP Annex 1 introduces new requirements relating to the entire freeze-drying process including product transfer. Now you can dive into the main aspects of the new requirements by analyzing a senior GMP inspector who worked with the Italian Ministry of Health and the Italian Medicines Agency for more than 20 years. You will also be involved in a case study concerning the development of an Aseptic Process Simulation for lyophilized products, that mimics as closely as possible the routine aseptic manufacturing process with a deep dive into a simulation of lyophilization justified by a scientific and risk-based approach.
    Track A
    • Requirements for Lyophilization in the New EU GMP Annex 1

      • Regulatory Presenter: Marisa Delbo, PharmD, Consultant , NA

    • A Better Approach to Aseptic Process Simulation (APS) for Lyophilized Products - APS Approach for Freeze-Drying Process Considering EU GMP Annex 1 Requirements

      • Presenter: Christian Scarpato, Process Engineering Manager, Merck

    • Q&A, Discussion

      • Moderator: Andrea Salmaso, PharmD, Corporate Regulatory and Scientific Affairs Manager, Stevanato Group

      • Panelist: Marisa Delbo, PharmD, Consultant , NA

      • Panelist: Christian Scarpato, Process Engineering Manager, Merck

  • Session 1, Track B: Sustainability in Aseptic Manufacturing

    Salon Köln, Bonn, Hamburg

    • Moderator: Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK

    Sustainability is a core value within the whole industry today and the pharmaceutical industry – aseptic process is not an exception. In this session, we will first give an insight into how design, technology, and innovation will participate in setting up sustainable solutions reducing our global impact on the environment by overviewing big levers e.g. Water for Injection (WFI), Steam generation, HVAC, circular economy (Single use and Take-back program). Then focus will be given to Big Data and Artificial intelligence (AI) to model material impact assessment. While discussing performance and growth, the success of the industry remains that the only way to continue to supply and deliver sustainably is to deliver safety, and compliance in an efficient way.
    Track B
    • From Sustainability Ambitions into Action: What About Aseptic Manufacturing?

      • Presenter: Michael Hell, PhD, Head of Environment / Sustainability Healthcare Operations, Merck Healthcare KGaA

    • Can We Have Reliable and Fast Sustainability Impact Assessments? Merging Technology, Innovation, and Sustainability

      • Presenter: Alissa Monk, Sustainability Lead , ten23 health

    • Q&A, Discussion

      • Moderator: Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK

      • Panelist: Michael Hell, PhD, Head of Environment / Sustainability Healthcare Operations, Merck Healthcare KGaA

      • Panelist: Alissa Monk, Sustainability Lead , ten23 health

  • Networking Coffee Break, Poster Session & Exhibition

    Saal MARITIM & Lobby Empore

  • Session 2, Track A: Filtration and Closed Systems

    Alte Stuttgarter Reithalle

    • Moderator: Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON

    At the heart of patient safety, aseptic processing is a critical component of drug product manufacturing, and ensuring the integrity of one’s process is paramount. During this session, we will have two subject matter experts on the subject speak about their experiences around filtration and single-use assembly integrity. They will assess the impact of regulations and implications on safety as well as extreme process conditions and steps that should be taken to ensure proper compliance.
    Track A
    • PUPSIT in the Revised EU GMP Annex I – Friend or Foe of the Pharmaceutical Entrepreneur?

      • Presenter: Manuel Grund, Process Engineer, Roche Pharmaceuticals

    • Contamination Control Strategies in Processing of Frozen Sterile Bulk Drug Product in Single-use Bag Assembly

      • Presenter: Yuan-An Liu, PhD, Associate Director CMC, BioNTech SE

    • Q&A, Discussion

      • Moderator: Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON

      • Panelist: Manuel Grund, Process Engineer, Roche Pharmaceuticals

      • Panelist: Yuan-An Liu, PhD, Associate Director CMC, BioNTech SE

  • Session 2, Track B: Aseptic Set-Up of Filling Machines

    Salon Köln, Bonn, Hamburg

    • Moderator: Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH

    With the requirements of the new EU GMP Annex 1, the aseptic set-up of a filling machine gets challenging. In former times you could use the VHP cycle as the final sterilization step. This is not possible anymore. Indirect product contact parts have to be (ideally steam-) sterilized and installed after the VHP cycle. The track shows two different approaches that are both relevant these days: One with an existing isolator line where you use enhanced “classical” methods to install the steam sterilized parts. And a completely newly developed machine with a gloveless isolator. Where you do steam sterilization for the indirect product contact parts and a fully automatic aseptic transfer and installation by using RTP ports and a robot. For the filling path, both solutions use pre-sterilized single-use filling systems.
    Track B
    • Implementing EU GMP Annex 1 Guidelines: A Comprehensive Approach to Sterility Assurance for Indirect Product Contact Parts

      • Presenter: Christian Rust, B.S. Chemical and Biomolecular Engineering, Technical Operations, MSD

    • Compliance with New EU GMP Annex 1 on a Fill/Finish Machine: A Glance into the Future

      • Presenter: Helen Sauter, Dr, Director Quality Assurance, Vetter Pharma Fertigung GmbH & Co. KG

    • Q&A, Discussion

      • Moderator: Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH

      • Panelist: Christian Rust, B.S. Chemical and Biomolecular Engineering, Technical Operations, MSD

      • Panelist: Helen Sauter, Dr, Director Quality Assurance, Vetter Pharma Fertigung GmbH & Co. KG

  • End of Conference Day 1 & Networking Event

Thursday, 16 May CEST

  • Registration Open

    Saal MARITIM & Lobby Empore

  • Session 3, Track A: Environmental Monitoring

    Alte Stuttgarter Reithalle

    • Moderator: Hue Kwon, PhD, Advisory consultant, GLS Advisors LLC

    This session will cover the latest developments in environmental monitoring (EM). The presenters will discuss how the data is utilized to adapt the new and updated approach for a better EM including the improvements enhanced to be compliant with Annex 1. The session will address new innovative ways to evaluate real-time continuous air monitoring. Two case studies will be presented, lessons learned from implementing total particle count tubing qualification on non-viable particle count systems and Automated Reading of Agar Plates using AI. Attendees will gain insights into the latest techniques in Environmental Monitoring, associated challenges and learnings, and how these advancements can be applied to impact our industry.
    Track A
    • Total Particle Count – Tubing Qualification at GSK: Lessons Learned

      • Co-Presenter: Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK

      • Co-Presenter: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK

    • How to Collect All Environmental Monitoring Data and Doing Computerized Trending Without Entering the Data Manually

      • Co-Presenter: Marc M. Machauer, OEM Coordinator, Particle Measuring Systems

      • Co-Presenter: Susan B. Cleary, B.CS, EMBA, Director Product Development, Novatek

    • Automated Reading of Agar Plates Using AI and Machine Learning

      • Presenter: Andrew Gravett, Principal Scientist Microbiology, AstraZeneca

    • Q&A, Discussion

      • Moderator: Hue Kwon, PhD, Advisory consultant, GLS Advisors LLC

      • Panelist: Paul Devuyst, Master Bioengineer, Senior Manager Aseptic Technologies, GSK

      • Panelist: Marc M. Machauer, OEM Coordinator, Particle Measuring Systems

      • Panelist: Andrew Gravett, Principal Scientist Microbiology, AstraZeneca

      • Panelist: Susan B. Cleary, B.CS, EMBA, Director Product Development, Novatek

  • Session 3, Track B: Equipment for Aseptic Processes

    Salon Köln, Bonn, Hamburg

    • Moderator: Tracy Moore, Director, TM Pharma Group Ltd

    During this session, we will explore the technological advancements that could enhance existing production lines and address specific material transfer needs to minimize particulates, pyro, and bioburden. The speakers will delve into strategies for aligning practices with the Annex requirements. We will discuss how leveraging technology can enhance aseptic environments and share insights on retrofitting equipment and processes to meet material transfer and sanitization standards. Our approach will break down these complex concepts into manageable steps that can be seamlessly integrated into your operations.
    Track B
    • EU GMP Annex 1 and 'Good Technology Practice' - Interpretation and Engineering for This Side of Production

      • Presenter: Johannes M. Rauschnabel, PhD, Director Advanced Technology Development and Innovation, Syntegon Technology GmbH

    • Critical Factors in the Material Transfer Process

      • Presenter: Anna Campanella, PhD, Global Aseptic Processing & Sterility Assurance Lead, Takeda Pharmaceuticals International AG

    • Disinfection and Material Intake Programs – Implementation, Challenges and Solutions

      • Presenter: David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences

    • Q&A, Discussion

      • Moderator: Tracy Moore, Director, TM Pharma Group Ltd

      • Panelist: Anna Campanella, PhD, Global Aseptic Processing & Sterility Assurance Lead, Takeda Pharmaceuticals International AG

      • Panelist: Johannes M. Rauschnabel, PhD, Director Advanced Technology Development and Innovation, Syntegon Technology GmbH

      • Panelist: David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences

  • Networking Coffee Break, Poster Session & Exhibition

    Saal MARITIM & Lobby Empore

  • Session 4, Track A: RABS/Isolator

    Alte Stuttgarter Reithalle

    • Moderator: David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences

    People, what they carry, and their actions are the major source of microbial contamination in aseptic operations. Isolator technology is a great way of preventing people from directly accessing critical areas. A perceived weak point in isolators can be the gloves, should they fail. Gloveless isolators take that control a step further by eliminating the need for people in the most critical of areas. Cleaning and disinfection has always been a principle control point for mitigating the risk of microbial contamination from people. Automating the disinfection process further reduces the risk by ensuring human error is controlled or even eliminated. Join us in these two talks to further understand how the latest technologies can help improve the quality of aseptic products and the environments we manufacture them.
    Track B
    • Pre-Validation of a Gloveless Isolator Filling Line - Experience and Lessons Learned

      • Presenter: Bianca Bohrer, Dipl Ing, Managing Director, PSM GmbH

    • Leveraging Emerging Technologies for H2O2 Bio-Decontamination: From Novel Process Data to Real Process Impact

      • Presenter: Martin Novak, MSc, Technology Lead, SKAN AG

    • Q&A, Discussion

      • Moderator: David Keen, MRSB CBiol, Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences

      • Panelist: Bianca Bohrer, Dipl Ing, Managing Director, PSM GmbH

      • Panelist: Martin Novak, MSc, Technology Lead, SKAN AG

  • Session 4, Track B: Quality Risk Management

    Salon Köln, Bonn, Hamburg

    • Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    Concerning the EU GMP Annex 1, QRM Quality Risk Management includes the Contamination Control Strategy CCS with all procedures and processes for the safe production of the sterile pharmaceutical product. An essential component of quality risk management is the ICH Q9 to identify the possible risks in the production of the sterile product and to integrate them into the contamination control strategy. In the Aseptic Process Simulation APS, the entire process is checked by all operators to ensure the sterility of the pharmaceutical drug.
    Track A
    • A Matter of Uncertainty: Risk Tool Selection With ICH Q9(R1) In Mind

      • Presenter: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    • Using Risk Management to Design Aseptic Process Simulations

      • Presenter: Alberto Gonzalez, Global Sterility Assurance Associate Director, Takeda

    • Q&A, Discussion

      • Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

      • Panelist: Alberto Gonzalez, Global Sterility Assurance Associate Director, Takeda

      • Panelist: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

  • Networking Lunch Break, Poster Session & Exhibition

    Saal MARITIM & Lobby Empore

  • Interactive Questionnaire Session

    Alte Stuttgarter Reithalle

    Plenary
  • Closing Plenary Part I

    Alte Stuttgarter Reithalle

    • Moderator: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

    Plenary
    • Excitement @Syntegon – Insights and Preparation for the Syntegon Factory Tour

      • Presenter: Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH

    • Introduction of PDA Points to Consider (PtC) for Aseptic Filling

      • Presenter: Julian Petersen, Head of Business Development, groninger & co. gmbh

    • Evolution of GMPs and Why They Are Particularly Important for Sterile Manufacturing

      • Presenter: Andrew D. Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

  • Networking Coffee Break, Poster Session & Exhibition

    Saal MARITIM & Lobby Empore

  • Passport Raffle

    Alte Stuttgarter Reithalle

    Plenary
  • Closing Plenary Part II

    Alte Stuttgarter Reithalle

    • Moderator: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

    Plenary
    • A Review of Recent Inspectional Trends: Aseptic Manufacturing - remote presentation -

      • Regulatory Presenter: Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA

    • Updates on EU GMP Annex 1 - remote presentation -

      • Regulatory Presenter: Roberto Conocchia, MD, GMP Technical Lead, European Medicine Agency

    • Plenary Discussion

      • Moderator: Simone Biel, PhD, Senior Regulatory Consultant, Merck

      • Moderator: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

      • Panelist: Julian Petersen, Head of Business Development, groninger & co. gmbh

      • Panelist: Andrew D. Hopkins, PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

      • Panelist: Roberto Conocchia, MD, GMP Technical Lead, European Medicine Agency

      • Panelist: Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA

      • Panelist: Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH

      • Panelist: Christina Meissner, AGES - Austrian Agency for Health and Food Safety

      • Panelist: Marisa Delbo, PharmD, Consultant , NA

      • Panelist: Daniel Mueller, PhD, Head of GMDP-Inspectorate, Regierungspraesidium Tuebingen, Germany

  • Conference Summary from the Co-Chairs

    Alte Stuttgarter Reithalle

    • Co-Chair: Simone Biel, PhD, Senior Regulatory Consultant, Merck

    • Co-Chair: Darren Beckett, Sr. Training and R&D Manager, Fedegari Technologies Inc

    Plenary
  • Closing Remarks & Farewell

    Alte Stuttgarter Reithalle

    • Committee Member: Falk Klar, PhD, Parenteral Drug Association

    Plenary

Posters

Biodecontamination of Raw Materials in Packaging Production Process
  • Andrea Weiss

CFD - Computational Fluid Dynamics for Airflow Visualization Studies
  • Christian Scarpato, Process Engineering Manager, Merck

eBeam Technology – Transfer Technology for Pre-Sterilized RTU Components
  • Manfred Holzer, Strategic Product Manager E-Beam Technology, SKAN AG

Environmental Monitoring in LIMS
  • Julia Wiesner, PhD, Senior Director, Head of QC & QA Systems, Merz Pharma GmbH & Co. KGaA

Far UV-C Light - Safe and Effective Decontamination
  • Peter Tonning

Headspace Analysis as Innovative Method for Media Fill Inspection
  • Michael Mettraux, MSc ETH, Development Engineer, WILCO AG

Particle Loss in Transport Tubing: How to Address the New Annex 1 Requirement
  • Serena Steidl, MD, EMEA Advisory Project Coordinator - Advisory Specialist , Particle Measuring Systems

Rapid Sterility Testing as the Critical and Final Result for Product Release - Design Verification (DV) Data
  • Johannes Oberdörfer, B.Sc, Field Application Scientist, Rapid Micro Biosystems

Reducing Glove Intervention in Fill & Finish Process
  • Patrick Wieland

The Need for High Quality in Primary Packaging
  • Niamh Bissett
  • Ana Kuschel, PhD, Principal Scientific Affairs, West Pharmaceutical Services, Inc.

Trending and Pattern Recognition for Annex1
  • Susan B. Cleary, B.CS, EMBA, Director Product Development, Novatek

VHP Uptake of Manufacturing Tubing Used for Aseptic Fill-Finish Processes of Biopharmaceutical Drug Products
  • Dilara Ali, MSc, PhD Student , ten23 health

Agenda is subject to change.

Presenters

  • Dilara Ali, MSc

    PhD Student , ten23 health

    Poster Presenter
    Read Bio
  • Darren Beckett

    Sr. Training and R&D Manager, Fedegari Technologies Inc

    Co-Chair
    Moderator
    Read Bio
  • Simone Biel, PhD

    Senior Regulatory Consultant, Merck

    Co-Chair
    Moderator
    Read Bio
  • Niamh Bissett

    Poster Presenter
  • Bianca Bohrer, Dipl Ing

    Managing Director, PSM GmbH

    Panelist
    Presenter
    Read Bio
  • Anna Campanella, PhD

    Global Aseptic Processing & Sterility Assurance Lead, Takeda Pharmaceuticals International AG

    Panelist
    Presenter
    Read Bio
  • Tarik Cheema, PhD

    End to End Contamination Control Manager, F. Hoffmann-La Roche AG

    Panelist
    Presenter
  • Susan B. Cleary, B.CS, EMBA

    Director Product Development, Novatek

    Co-Presenter
    Panelist
    Poster Presenter
    Read Bio
  • Roberto Conocchia, MD

    GMP Technical Lead, European Medicine Agency

    Panelist
    Regulatory Presenter
    Read Bio
  • Melanie Decker

    Parenteral Drug Association

    Moderator
  • Marisa Delbo, PharmD

    Consultant , NA

    Panelist
    Regulatory Presenter
    Read Bio
  • Richard Denk

    Senior Consulting Aseptic Processing & Containment, SKAN AG

    Committee Member
    Moderator
    Read Bio
  • Paul Devuyst, Master Bioengineer

    Senior Manager Aseptic Technologies, GSK

    Committee Member
    Co-Presenter
    Moderator
    Panelist
    Read Bio
  • Rainer Glöckler

    Swissfillon - a Ten23 Health Company

    Committee Member
    Read Bio
  • Alberto Gonzalez

    Global Sterility Assurance Associate Director, Takeda

    Panelist
    Presenter
    Read Bio
  • Andrew Gravett

    Principal Scientist Microbiology, AstraZeneca

    Panelist
    Presenter
    Read Bio
  • Manuel Grund

    Process Engineer, Roche Pharmaceuticals

    Panelist
    Presenter
    Read Bio
  • Thorsten Haefner, MBA

    Vice President of Business Development, PSM GmbH

    Panelist
    Presenter
    Read Bio
  • Michael Hell, PhD

    Head of Environment / Sustainability Healthcare Operations, Merck Healthcare KGaA

    Panelist
    Presenter
    Read Bio
  • Brooke K. Higgins, MS

    Branch Chief, OC, CDER, U.S. FDA

    Panelist
    Regulatory Presenter
    Read Bio
  • Manfred Holzer

    Strategic Product Manager E-Beam Technology, SKAN AG

    Poster Presenter
    Read Bio
  • Andrew D. Hopkins, PGDip

    Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

    Panelist
    Presenter
    Read Bio
  • Kurt Jaecques, MA

    Global Aseptic Technologies Lead Monitoring & Control, GSK

    Co-Presenter
    Read Bio
  • Hussain Jafri, PhD

    Executive Director , World Patients Alliance

    Panelist
    Presenter
    Read Bio
  • David Keen, MRSB CBiol

    Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences

    Committee Member
    Moderator
    Panelist
    Presenter
    Read Bio
  • Falk Klar, PhD

    Parenteral Drug Association

    Committee Member
    Read Bio
  • Ana Kuschel, PhD

    Principal Scientific Affairs, West Pharmaceutical Services, Inc.

    Poster Presenter
    Read Bio
  • Hue Kwon, PhD

    Advisory consultant, GLS Advisors LLC

    Committee Member
    Moderator
    Read Bio
  • Yuan-An Liu, PhD

    Associate Director CMC, BioNTech SE

    Panelist
    Presenter
    Read Bio
  • Marc M. Machauer

    OEM Coordinator, Particle Measuring Systems

    Co-Presenter
    Panelist
    Read Bio
  • Peter J. Makowenskyj, MEng

    Director of Design Consulting, G-CON

    Committee Member
    Moderator
    Read Bio
  • Amanda McFarland, MS

    Senior Consultant, ValSource, Inc.

    Panelist
    Presenter
    Read Bio
  • Christina Meissner

    AGES - Austrian Agency for Health and Food Safety

    Panelist
    Regulatory Committee Member
    Regulatory Presenter
    Read Bio
  • Michael Mettraux, MSc ETH

    Development Engineer, WILCO AG

    Poster Presenter
    Read Bio
  • Alissa Monk

    Sustainability Lead , ten23 health

    Panelist
    Presenter
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  • Tracy Moore

    Director, TM Pharma Group Ltd

    Committee Member
    Moderator
    Panelist
    Presenter
    Read Bio
  • Daniel Mueller, PhD

    Head of GMDP-Inspectorate, Regierungspraesidium Tuebingen, Germany

    Panelist
    Regulatory Presenter
    Read Bio
  • Martin Novak, MSc

    Technology Lead, SKAN AG

    Panelist
    Presenter
    Read Bio
  • Johannes Oberdörfer, B.Sc

    Field Application Scientist, Rapid Micro Biosystems

    Poster Presenter
    Read Bio
  • Julian Petersen

    Head of Business Development, groninger & co. gmbh

    Panelist
    Presenter
    Read Bio
  • Johannes M. Rauschnabel, PhD

    Director Advanced Technology Development and Innovation, Syntegon Technology GmbH

    Panelist
    Presenter
    Read Bio
  • Christian Rust, B.S. Chemical and Biomolecular Engineering

    Technical Operations, MSD

    Panelist
    Presenter
    Read Bio
  • Andrea Salmaso, PharmD

    Corporate Regulatory and Scientific Affairs Manager, Stevanato Group

    Committee Member
    Moderator
    Read Bio
  • Helen Sauter, Dr

    Director Quality Assurance, Vetter Pharma Fertigung GmbH & Co. KG

    Committee Member
    Panelist
    Presenter
    Read Bio
  • Christian Scarpato

    Process Engineering Manager, Merck

    Panelist
    Poster Presenter
    Presenter
    Read Bio
  • Serena Steidl, MD

    EMEA Advisory Project Coordinator - Advisory Specialist , Particle Measuring Systems

    Poster Presenter
    Read Bio
  • Peter Tonning

    Poster Presenter
  • Klaus Ullherr

    Senior Product Manager, Syntegon Technology GmbH

    Committee Member
    Moderator
    Panelist
    Presenter
    Read Bio
  • Andrea Weiss

    Poster Presenter
  • Patrick Wieland

    Poster Presenter
  • Julia Wiesner, PhD

    Senior Director, Head of QC & QA Systems, Merz Pharma GmbH & Co. KGaA

    Poster Presenter
    Read Bio

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.

 The booking cut-off date is 1 February 2024.
How to Get Here
By Air If you're flying into Stuttgart, you'll land at Stuttgart Airport (STR). From there, you can take a taxi or use public transportation to reach the Maritim Hotel. The airport is approximately 15 kilometers away from the hotel, and you can take the S-Bahn (S2 or S3) from the airport to Stuttgart Hauptbahnhof (main train station), and then transfer to the U-Bahn (U12) towards Dürrlewang. The Maritim Hotel is located near the Liederhalle station.
By Car Stuttgart is well-connected by highways, including the A8, A81, and A831. Once you reach Stuttgart, follow the signs to the city center and then to the Maritim Hotel. The hotel offers parking facilities for guests at 22 EUR per day.
By Other Options Stuttgart has an efficient public transportation system consisting of S-Bahn (suburban trains), U-Bahn (subway), and buses. From Stuttgart Hauptbahnhof, you can take the U12 towards Dürrlewang and get off at Liederhalle station, which is close to the Maritim Hotel on Seidenstrasse.
Travel and Exclusive Discount Information
Special Lufthansa Group Airlines Fares
Special Lufthansa Group Airlines Fares

The Lufthansa Group airlines bring people together – every day, all around the world.The global route network of Austrian Airlines, Lufthansa, SWISS, Brussels Airlines and Eurowings offers optimal connection and combination options, so you will benefit from quick and direct flights to the event.

You will reach the booking platform via this link https://www.lufthansa.com/de/en/meetings-and-events-delegates and with the event code DEAPILX. The reduced fares are automatically displayed.

Note: Please enable pop-ups permanently in your browser while booking, otherwise the window in the booking platform will not open.

Of course, you can also book through your IATA travel agency. The travel agency can request the ticketing instructions by sending an email to lufthansa.mobility@dlh.de, stating the event code DEAPILX.

Book Flight
Special Deutsche Bahn Train Fares
Deutsche Bahn Train logo

Get there relaxed – get there sustainable – travel CO2-free. Your Event Ticket at a fixed price throughout Germany. From any Deutsche Bahn station to our event, with the City-Ticket included.

Event Ticket one-way and specific train (subject to availability):

  • 1st class 89,90€ (seat reservation incl.)
  • 2nd class 55,90€

Event Ticket one-way and fully flexible:

  • 1st class 112,90€ (seat reservation incl.)
  • 2nd class 77,90€

Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.

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Area Attractions
  • Visit the Mercedes-Benz Museum: Explore the fascinating history of Mercedes-Benz and its iconic automobiles.
  • Stuttgart Zoo Wilhelma: Spend a day discovering a wide variety of animals in this beautiful zoological and botanical garden.
  • Stuttgart State Gallery: Admire impressive collections of art ranging from the Middle Ages to contemporary works.
  • Schlossplatz: Relax in this picturesque square surrounded by historical buildings, fountains, and green spaces.
  • Stuttgart TV Tower (Fernsehturm): Enjoy panoramic views of Stuttgart and its surroundings from the top of this iconic tower.
  • Shop at Königstrasse: Explore one of the longest pedestrian streets in Europe, lined with shops, cafes, and restaurants.
  • Porsche Museum: Delve into the history of Porsche and see some of the most iconic sports cars ever made.
  • Feuersee: Take a stroll around this charming lake surrounded by parks and historic buildings.
  • Stuttgart Beer Festival (Stuttgarter Frühlingsfest): If you're visiting during spring, don't miss this lively festival with beer tents, amusement rides, and traditional food.
  • Stuttgart Opera House: Catch a performance at one of Germany's leading opera houses, known for its exceptional productions.