For Plant Operators, Engineers, and Managers
Objectives
The objective of this intensive education course is to enable the participants to pay optimal attention to critical issues during the design, qualification, and routine operation of pharmaceutical water systems.
You will learn:
- How to meet the pharmacopoeial requirements
- How to find the critical design aspects in a water system
- How to generate pharmaceutical water and steam in the desired quality
- How commissioning and qualification is done today
- How microbial validation and control is achieved
- How the systems is maintained in a controlled status during its life cycle
Overview
Water is one of the most important raw materials in the manufacture of pharmaceutical products. In order to produce water of appropriate quality, water systems have to fulfill considerable requirements, which are partly set out in detail in the relevant pharmaceutical regulations. Although the characteristics of pharmaceutical waters are sufficiently defined, a large number of questions remain unanswered as regards to the technical implementation of these bodies of regulations in GMP-conform water systems.
The main focus of the course ‘Pharmaceutical Water’ is therefore on how to put these requirements into practice. In their lectures, experienced specialists will give you important information and support for your own projects and systems, ranging from regulatory requirements, design, qualification, validation, and routine operation.
WHO IS THIS TRAINING COURSE FOR?
This GMP course is directed to engineers, production, and QA/QC staff, responsible for the design, validation, and operation of pharmaceutical water systems as well as system suppliers and design engineers.