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ECA - Trends in Manufacturing

Objectives

Continuous Manufacturing (24. April 2018)

It is the aim of this conference to show how a transition from batch to continuous manufacturing in the pharmaceutical industry can look like. Questions regarding technology, process development and GMP/Quality Assurance will be discussed.

OSD Manufacture and Packaging (25. April 2018)

This conference focusses on current topics in secondary manufacturing. Handling of highly potent products and the implementation of track & trace systems play major roles here. Modern organization concepts of packaging facilities supplement this conference.

 

Highlights

Continuous Manufacturing (24. April 2018)

  • Continuous Manufacturing from a Quality Perspective
  • Regulatory aspects of continuous manufacturing?
  • Case Study Janssen Pharmaceutica
  • Case Study GSK
  • Case Study Corden Pharma
  • Case Study Pfizer

 

OSD Manufacture and Packging (25. April 2018)

  • Containment und Exposure Limits for highly potent products
  • High Containment Manufacturing at R-Pharm Germany: Fully Automated vs. Manual Processes
  • Serialization in Europe & the current status of securPharm
  • Serialization & Aggregation as a Contract Manufacturer
  • The new Packaging Facility at Novartis Stein
  • Global comparison of GMP requirements for OSD and Packaging operations

 

Speakers

  • Gunther Bechmann, Pfizer
  • Martin Bergen, securPharm
  • Dr. Lorenzo Capretto, GlaxoSmithKline
  • Dr. Rainer Gnibl, GMP-Inspector, Germany
  • Andreas Hänel, R-Pharm Germany
  • Dr. Gerhard Jas, Corden Pharma
  • Nick Lee, Health Product Regulatory Agency (HPRA), Ireland
  • Dr. Jean-Denis Mallet, ECA Advisory Board Member
  • Dr. Eric Meier, Novartis
  • Yves Michon, Corden Pharma
  • Dr. Giustino Di Pretoro, Johnson & Johnson
  • Dr. Thomas Schwarz, Novartis
  • Dr. Harald Stahl, GEA
  • Michael Unbehaun, R-Pharm Germany

 

Trends in Manufacturing

 

PDF of the ECA Conference Trends in Manufacturing

  • Continuous Manufacturing (24 April 2018)
  • OSD Manufacture and Packaging (25 April 2018)

Get a complete overview in the Schedule.