Pharmaceutical Water Systems

Successful specification, design, installation, validation, management and control of a pharmaceutical water system depends on a coordinated, multi-disciplinary approach. The course will be valuable for those in pharmaceutical, biotechnology and medical device manufacturing who are responsible for or involved in:

-Specification and engineering design
-Technical and validation support
-Regulatory compliance activities and auditing
-Risk assessment, troubleshooting and system improvement
-Water system operation, management and maintenance
-Quality assurance and validation management
-Quality control, sampling, microbiological and chemical analysis

Learning Objectives

Upon completion of this course you will:

-Understand the water types, qualities, uses and applications in pharmaceuticals, biotechnology and medical device manufacture
-Be familiar with the applications and limitations of the range of treatment technologies and able to choose the most effective combination of techniques for your needs
-Appreciate the importance of a “common-sense” approach to the implementation of cost-effective design solutions
-Be aware of the GMP requirements and regulatory expectations relating to water systems and their validation requirements
-Have gained a practical understanding of systems via examples and discussions
-Have developed better knowledge and understanding between the different disciplines involved in the operation and management of water systems
-The course will also provide a discussion forum to exchange ideas and experience and to learn from each other.

Course Description

An interactive mix of lectures and discussions intended to highlight basic principles and technologies and how these are applied in practice to pharmaceutical water systems. The course is intended to raise practical understanding and awareness for water system owners and managers, QA managers, regulatory compliance staff, microbiologists, engineers, validation specialists and operators.