1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com

About this course

Water is the single largest volume product of the pharmaceutical industry. Because water comes into contact with product frequently during the manufacturing process and even can be part of the final product itself its generation and use is highly regulated. Yet, water issues still rank second - after validation problems - on the list of objectionable findings in regulatory inspections. 

This course teaches the current US, European and Japanese requirements for water systems design, validation, operation and maintenance and discusses optimum design strategies based on specific case studies for new and renovated facilities, both, domestic and off-shore, meeting regulatory expectations.

You will benefit from this course, if you belong to the

• engineering and maintenance staff,
• validation personnel,
• QA or QC staff,
• process development personnel,
• manufacturing department or
• regulatory compliance group

Vendors to the healthcare product manufacturing industry, contractors and anybody who needs a more thorough understanding of the technical and regulatory aspects of the generation and maintenance of compendial water will also greatly benefit from this course.

This course will teach you the basics and will improve your knowledge of

• the science of water and its microbiological implications
• current national and international regulatory concerns and requirements
• the principles of water treatment and ultrapure water production
• current and emerging regulatory water requirements
• water requirements of various pharmaceutical operations
• water requirements for both GMP and non-GMP operations
• water systems layout, design, installation and operation
• selecting an appropriate water system
• water system validation and ongoing sampling
• designing and operating water distribution networks