Interview ISPE

First Europe Annual Conference Raises a flag for More Europe in the ISPE

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What will be going on in the parallel sessions?

Zimmer: The three tracks are Quality by Design, Quality Risk Management and Facilities of the Future. The use of disposables in production will be addressed in the Quality Risk Management and Facility of the Future tracks. Using practical examples, we will explain how to make the transition from conventional technology to single-use items, in other words how to set up Post-Approval Change Management and what the costing might look like. If this type of approach can simplify revalidation, companies may be able to save a lot of money. The list of other topics includes new strategies for continuous production, especially in the biotech industry. We place great emphasis on providing information that is of particular interest to Production Engineers, Production Managers, Production Foremen and other technical personnel who work at the practical level.

Your target audience is front-line staff as well as management. What will the various participants take away with them?

Zimmer: The conference as a whole spans a spectrum ranging from regulatory requirements and their importance in practical application continuing right through to the potential consequences of non-compliance for companies and the supply of drugs to the market. In this way, we are able to promote a dialogue between management and front-line staff. Management learns that lean production and compliance are not necessarily conflicting goals. Based on best-practice, the people who work on the front-line learn how implementation can be carried out in the plant. ●

* The interview was conducted by Anke Geipel-Kern, PROCESS Managing Editor.