COURSE DESCRIPTION

OVERVIEW

The pharmaceutical research and development (R&D) process requires water. Not just any water, but pharmaceutical grade water. Throughout the process, water is used as an ingredient, a cleaner of manufacturing equipment, and a key element of quality testing. If a company cannot meet and maintain legally-required water standards, they cannot sell their products.

Furthermore, employees are required to be knowledgeable about pharma water system requirements to assure their employers produce safe products. The knowledge includes the principles of producing pharmaceutical grades of water to established minimal standards, storing it in quantities to meet production needs, and distributing it to several points of use while maintaining the minimal chemical and microbial requirements. Training of personnel to assure the water produced meets and maintains standards is critical to a company’s success. US Food and Drug Administration (FDA) regulatory observations and enforcement actions regarding water systems continue to plague industry. To add pain to the process…it isn’t cheap. This session will teach you ways to remain compliant and increase efficiencies through best practices.

LEARNING OBJECTIVES

During this course, you will…

1. Review the production of Pharma Water from feed water to Points-of-Use
2. Identify common pitfalls and problem areas when commissioning and qualifying your water systems, and the problems FDA cites most frequently
3. Contrast what makes for a good water systems program, and what will ensure failure
4. Prepare your efforts with best practices from an industry veteran
5. Receive job aids and other resources to help you with your efforts

Additionally, you will discover…

• The different grades of pharm water and their uses
• The multitudes of pharma water production equipment and configurations in use
• The differences in existing global regulations