GMP-compliant and cost-effective sterile manufacturing

GMP-compliant and cost-effective sterile manufacturing

The Weiss Klimatechnik GmbH is hosting a Cleanroom Symposium for pharmacists on November 16 and 17 at the VILA VITA Hotel & Residenz Rosenpark in Marburg.

     WEISS Symposium
     November 16-17 in Marburg

Invited are retail pharmacists, operators, and decision-makers from hospital pharmacies or compounding centers. At this two-day, free event, participants can gain an overview of all the know-how required for the creation and operation of cytostatics and sterile laboratories – both theoretically and practically. Recognized experts and representatives from approval authorities will present practical solutions for a work environment shaped by market consolidation, increasing price pressure, and complex regulations. The broad range of topics includes issues of health policy relevance, economic efficiency, legal certainty, and the legal foundations – including international standards – for cytostatics and sterile production, as well as equipment and monitoring, microbiology, and GMP qualification.

Among the speakers are Prof. Dr. Horst Weißsieker (TÜV SÜD Cleancert), medical law expert Prof. Dr. iur. Dr. med. Alexander P.F. Ehlers (Ehlers, Ehlers & Partner Law Firm), Dr. Thomas Schreiner (Fresenius Kabi Germany), Dr. Luzian Baumann (Hessenklinik Wetzlar), a representative from the approval authorities, and Karl-Heinz Lotz (Weiss Klimatechnik).

A complete program overview, including a registration form, is published at www.weisssymposium.de.

In addition to technical presentations, a panel discussion is planned, as well as the opportunity to individually question the speakers. Participants can also engage practically with exhibits on site: as part of a "Speed Dating," they can visit three themed islands – each with approximately half-hour short presentations and exhibits "to touch": Cytostatics workbenches (Thomas Hinrichs, Berner International GmbH); Monitoring systems (Dr.-Ing. Jürgen Blattner, BSR Engineering Office); Qualification (Anja Monning, Fresenius Kabi Germany, and Kerstin Glöser, Weiss Klimatechnik). Furthermore, the symposium offers the chance to exchange ideas with colleagues in the field.

Program overview:
- Insights into the political dimension of the topic will be provided by medical law expert Prof. Dr. iur. Dr. med. Alexander P.F. Ehlers from the law firm Ehlers, Ehlers & Partner.
- Dr. Thomas Schreiner from Fresenius Kabi Germany will discuss GMP in compounding – national and international trends.
- Dr. Luzian Baumann (Hessenklinik Wetzlar) will speak on GMP and microbiological validation, as well as his experiences as a "builder" of a cytostatics pharmacy.
- A representative from the approval authorities will give a comprehensive overview of relevant legal foundations and regulations.
- Prof. Horst Weißsieker (TÜV SÜD Cleancert) and Karl-Heinz Lotz (Weiss Klimatechnik) will discuss the special importance of the cleanroom in the pharmacy and its operation – including a comprehensive checklist.