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
Click on the image to download the PharmaCongress Programme.
Info Brochure
Click on the image to download the Info Brochure.
GMP/FDA Compliant Facilities & Technology
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
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
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
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
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
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