6th and 7th of June 2016
Purpose of the training:
The Training is addressed to the Professionals and Managers of the Pharmaceutical Industries involved in the Pharmaceutical Water and Steam Systems Applications as Quality Systems(Q.A. and QC), Regulatory & Validation, Pharmaceutical Engineering & Maintenance and Manufacturing(API&DosageForms). The Seminar will explore the topics “PHARMACEUTICAL WATER” & “PHARMACEUTICAL STEAM” giving a complete overview from the European Union (EDQM/EMA), from the USA (FDA/USP) as well as from the international cGMP(e.g.Anvisa,WHO, PIC/S, ecc) and sharing Stilmas-DOC international experience on Plants Inspection with all participants. The Seminar material is updated as per current early 2016 Regulatory Requirements, especially due to the New Revised EP monograph for Water for Injection planned to be released onOctober 2016.
The Training will exploreand address in detail the following aspects:
- REGULATORY REQUIREMENTS
- CURRENT DESIGN CRITERIA
- VALIDATION LIFE-CYCLE
- SYSTEMS MAINTENANCE, MONITORING & CONTROL