Presentations for Download

Following you will find all presentations available for your download. The site will be continuously updated - and new presentations will be uploaded as soon as they are available. So you may want to check the site for updates and new presentations. We hope for your understanding, though, that due to restrictions from the authors some presentations may not be available for download.

Programme

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PharmaCongress Programme and Agenda

Info Brochure

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PharmaCongress Info Brochure

GMP/FDA Compliant Facilities & Technology

Presentations - 31 May 2022

UPDATE (24 May): The LSCC Program
Thomas Zlabinger, Boehringer Ingelheim

IDT Biologika: Design & Implementation of new flexible (modular) Vaccine Production Facility
Dr Daniel Minör, IDT Biologika
Dirk Steinhäuser, Glatt Ingenieurtechnik

Merz: Investment in Dessau
Fred Wulfgramm, Merz Pharma

CSL Behring: Challenges due to limited Space in the existing Building during Construction Phase
Matthias Klein, CSL Behring
Steffen Mörler, CSL Behring

Microwave-assisted freeze-drying of Biologicals
Nicole Härdter, Ludwig-Maximilians-Universität München

Vetter Pharma: Integration of an existing pharmaceutical Manufacturing Site into Vetter’s Development Services
Dr Martin Schwab, Site Manager Vetter Development Services, Austria

Novo Nordisk: Closed Systems in CNC Ballroom, A Risk Based Approach
Lars Hovmand-Lyster, Novo Nordisk

Presentations - 1 June 2022

Merck's new modular GMP Plant for clinical DP Manufacturing
Dr Markus Weigandt, Merck Healthcare

Boehringer Ingelheim: New solid launch Facility for Containment
Volker Glück, Boehringer Ingelheim
Ilka Rudzio-von Arx, Pharmaplan

Implementation of cold WFI systems in Europe
Markus Multhauf, ECA Validation Group

Roche: CAPEX Project Delivery for What Patients Need Now
John Honey, Roche
Alois Probst, Roche

Road from Design, Commissioning, Qualification to Process Validation for Fast tracked Projects
Udara Yapa, Wuxi Biologics

Aseptic Sterile Filtration using Single Use and Isolator Technologies
Nicola Rutigliani, Merck

FUJIFILM Diosynth Biotechnologies CDMO: Multifunctional Single-Use Purification System for connected and integrated Continuous Processing
Dave Mills, GEMÜ
Dr Charles Heise, Fujifilm

GMP/FDA Compliance Conference

Presentations - 31 May 2022

Experience from COVID-19-Pandemic- a GMDP-Inspector’s View
Dr. Daniel Müller, Local GMP Authority of Baden Württemberg

GMP Compliance Trends during COVID-19 Outbreak
Balasubramanian Ramaiah, Accord Healthcare

UPDATE (25 May): From Risk Analyses to Traceability Matrix 4.0
Christoph Holzmann, MSD AH Danube Biotech
Dr. Birgit Gübitz, VTU Engineering

The ECA Good Practice Guide for Suppliers and Users on integrated Qualification and Validation
Gert Moelgaard, Moelgaard Consulting

Update on USP’s Bioreactivity, Extractables and Glass Containers Packaging
Dr. Michael Eakins, Eakins & Associates

Review of Online Water Monitoring Analyzers (OWBA) and their potential Application
Dr. Hans-Joachim Anders, Novartis Pharma Stein

Ensuring Data Integrity in the daily Practice of Pharmaceutical Manufacturing
Dr. Philip Hörsch, Vetter Pharma-Fertigung

Presentations - 1 June 2022

Update EU GMP Annex 1
Dr. Daniel Müller, Local GMP Authority of Baden Württemberg

Compliance trends and their Impact on Technological Developments (in sterile Manufacture)
Jörg Zimmermann, Vetter Pharma-Fertigung

Airflow Visualization / Aseptic Process Simulation
Luigi Scaffidi, Boehringer Ingelheim Pharma
Christian Gavranovic, PPT Pharma Process Technology

Sterile Filtration – How to Keep Flexibility and Regulatory Compliance
Simone Biel, Merck

Quality Assurance for Contrast Media – Parametric Release & New Annex 1
Dr. Stephan Heck, Bipso

CCS (Contamination Control Strategy): Is it really a new Tool?
Jean Denis Mallet, ECA

How to implement a CCS according to Annex 1 (“A Guide to the Guide”)
Robert G. Schwarz, GXP-TrainCon e.U.

European Aseptic Conference

Presentations - 31 May 2022

A new Industry Standard for Automated Fill & Finish of Small Batches
Dr Ute Schleyer, Vetter Pharma-Fertigung
Tobias Goettler, Syntegon Technology

SANDBOX Concept Roche Mannheim, Germany – Playground for new Technologies / Robotics in Pharma – Challenges and Chances
Marko Hahn, Roche Diagnostics
Rudolf M. Weiss, Stäubli Tec-Systems

Implemenation of a gloveless Robotic Filling Line at the German CDMO PSM GmbH in Light of the new EU GMP Annex 1 (Draft)
Bianca Bohrer, PSM/Topmedicare
Thorsten Häfner, groninger

Bio-Decontamination of 1,500 m2 Pharma Production using one fully automated Decontamination System
Maria Jasmin Müller, IDT Biologika
Matthias Buttazoni, Ortner Reinraumtechnik

Novel Ways of Rapid Freeze Drying (this presentation will not be available for download)
Benjamin Ledermann, GEA Lyophil

Use and Design of Disposable Filling Isolator Technology
Frank Pavan, GTP Nano

STISO® with DECOpulse® – 3 x validated Sterility Test Isolators for Roche Microbiology
Lena Hartling, Roche Diagnostics
Kenan Kanmaz, Metall + Plastic

Cost Efficiency in Pharma Manufacturing

Presentations - 1 June 2022

Harmonisation of Industry 4.0 interfaces
Dr Andreas Weber, Evonik

Modernization & Digitalization at TEVA Operations
Frank Streil, TEVA

Takeda: Process Mapping to identify Automation Opportunities in Pharmaceutical Manufacturing
Dr Frank Thielmann, Takeda

Automatic Processing of Reports from Environmental Monitoring Systems
Alfred Gilgen, CSL Behring

Boehringer Ingelheim microParts: Step by Step to more Efficiency - from Company Objectives to Process Improvement
Guido Bünder, Boehringer Ingelheim microParts

Current Manufacturing Compliance & Efficiency Trends and their Implementation
Steliyan Tinkov, Lonza

Quality, a Way to improve Cost Efficiency
Ana Cláudia Pinho, BIAL

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