Pharmaceutical Waters (Live Webcast)

Course Description
This course explains compendial and regulatory requirements for source waters, purified water, water for injections, sterile water for injections and other sterile water monographs and water for hemodialysis and pure steam. It examines the systems that produce these waters as well as the chemical and microbiological controls that are required to ensure chemical and microbiological attributes are maintained. The course will also address proposed changes for the water related USP General Chapters <643> Total Organic Carbon, <645> Water Conductivity and <1231> Water for Pharmaceutical Purposes.

Upon completion of this course, you will be able to:

• Explain the importance of source water quality and pre-treatment concerns.
• Summarize the requirements for purified water, water for injection and other USP water monographs, including specifications, testing, and instrumentation.
• Explain the impact of elemental impurities requirements according to USP General Chapter <232>.
• Describe how biofilm propagates in pharmaceutical water systems.
• Explain how biofilm impacts purification unit operations and water quality.
• Discuss how to control the chemical and microbial quality of the water.
• Identify the realities and myths for microbial control in pharmaceutical water systems.
• Summarize ongoing pharmaceutical water initiatives.

Who should participate:

• Water system designers
• Regulatory Authorities
• Pharmaceutical Engineers
• Process Engineers
• QA & QC Scientists
• QA & QC Managers/Staff
• Maintenance Personnel