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ISPE Hands-On Aseptic Processing & Annex 1 Training Course

2-Day Training Event at the European Aseptic and Sterile Environment

24 - 25 SEPT 2024 | (EASE) Facility Strasbourg, France

To meet the challenges of a science and risk-based approach, while enhancing industry efforts to develop, manufacture, and reliably deliver quality medicines to patients, ISPE is conducting a 2-day training event in a unique setting, the European Aseptic and Sterile Environment (EASE) Facility in Strasbourg, France.

What to Expect?

Overview of EASE Facility

Strasbourg, France


Aseptic Processing & Annex 1 - Days 1 and 2

Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex 1.

Globally supplying companies, which deliver sterile drugs to Europe, must comply with this new regulatory requirement. There is an impact for all stakeholders of manufacturing, across hierarchy levels and various functions at manufacturers. Also, suppliers have to consider Annex 1 when supplying new equipment or installing new production facilities.

This course will focus on aseptic processing and quality management regarding pharmaceutical technology. The training course will provide ample time in clean rooms for various practical exercises, allowing participants to engage in hands-on operations. These sessions will occur in the clean rooms of the EASE platform.

Linked to the lecture on aseptic process and facilities design, attendees will tour the facility to observe the practical implementation of the EASE facility design and conduct exercises to ensure compliance. In terms of processes, the training will enable participants to perform manipulations for aseptic operations within biosafety cabinets (BSC), and comprehend upstream processes, preparation, and connections/disconnections.

Additionally, attendees will explore the Restricted Access Barrier Systems (RABS) and an aseptic filling line in the EASE facility's preparation room, observing equipment loading procedures and understanding their usage. Subsequently, participants will move to the room housing the filling machine, where machine setup operations will be discussed, and a smoke study demonstration will be conducted to allow attendees to observe the effects on actions within critical areas. This part of the training will focus on learning how to operate a RABS machine effectively.


Upon completing days 1 and 2 of this event, you will:

  • Understand the new EC GMP Guide Annex 1 and its impact on future aseptic processing supported with practical exercises.
  • Determine the current industry standards for manufacturing and environmental control.
  • Engage in critical topics discussion in regulators inspections.
  • Manage practical aspects of aseptic filling operations.
  • Introduction to the Regulatory Framework
  • Hot Topics from Annex 1
  • Interaction of Process and Aseptic Fill/Finish Operations
  • Principles of Aseptic Processing
  • Process Development and Validation
  • Quality Risk Management
  • Training Systems
  • Interactive Session/Case-Based Learning
  • How to Prepare for Regulatory Inspections
Jean-François Duliere
Regulatory Advisor

Who should attend this 2-Day hands-on training event?

  • Managers of production and quality assurance
  • Process engineers
  • Engineers responsible for infrastructure and maintenance
  • Quality managers
  • Shop floor supervisors
  • Middle management
  • Department heads
  • Suppliers for equipment and infrastructure of aseptic manufacturing plants

Register Now!


 Early Registration *Ends 10 Jun 2024Regular Registration
Non Member$1,885.00$2,185.00

All prices exclude VAT at 20%

EASE Training Facility

  • EASE, Campus d’ILLKIRCH 80 route du Rhin 67400 ILLKIRCH, France EU

    EASE, Campus d’ILLKIRCH 80 route du Rhin 67400 ILLKIRCH, France EU

  • Upstream

    Production & QC area upstream

  • Upstream 2

    Production & QC area upstream 2

  • Production area for sterile liquids

    Production area for sterile liquids

  • Production area for dry forms

    Production area for dry forms

  • Air treatment system

    Air treatment system