September 24-25: The agenda is designed to encourage discussion and networking with colleagues in our industry as well as key component and equipment suppliers and regulators. The conference will provide you with practical information you can apply immediately upon returning to the workplace.

Some of the highlights of the conference include:

• An overview on regulatory aspects and trends
• Aspects of development associated with freeze drying, implementation of new monitoring methods
• An update on controlled nucleation
• Risk based scale up models and process technology for freeze drying processes
• Freeze drying technology updates and innovations in equipment
• The latest on containers and stoppers, also alternative solutions
• The challenges of technology transfer and aseptic lyophilization processing

ICH Q9: Application of a Risk-based Approach to Freeze Drying Processes (Düsseldorf, Germany)

September 26: This one day training course will introduce the concept of risk management described in the ICH Q9 and will apply it to the freeze drying process. The first part will review the guidelines, the freeze drying process and the tools available to score the risks. In the second part the session will be fully interactive. The participants will express their view in term of detectability, occurrence and control of the various risk linked to the freeze drying process. The process will be subdivided in different chapter: product, process, critical quality attributes ancillary function of the equipment and aseptic level. The day will be closed by answering the different questions remaining and by an review of the usefulness of the approach.

The training will provide to the participant:

• A practical approach to risk management
• A deeper understanding of the freeze drying process
• Learning from peers during the practical part
• A methodology to perform risk management