PTI - international

Water is a component of every pharmaceutical product, and water systems must be validated to ensure the consistent production of high-quality water. Regulatory enforcement actions, approval delays and recalls all may ensue if water does not meet FDA and USP standards. This course will provide a thorough look at water systems, from planning and implementation, to validation and maintenance, with a particular focus on validation. The course begins by addressing the various types of water, as well as common contaminants and methods for pre-treatment and purification. Participants evaluate materials and other aspects of the design of an efficient, compliant water system. Best practices for sampling will be detailed. FDA and USP expectations also are examined, including documentation requirements. Through lecture, group discussions and interactive exercises, participants gain a complete understanding of water systems and return to their jobs able to achieve compliance and improve quality.