Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

The course consists of interactive lectures, discussions, and imbedded exercises. Participants will also be placed in several real life situations where they complete a compliance review of a schematic process flow diagram, analyze failures using trend reports, critique a risk assessment, and perform a change control analysis including the impact of requested or proposed modifications.

The course is designed to provide the attendee with a practical understanding of the following topics:

• Basic water chemistry
• Water quality selection criteria
• EPA, EU, and WHO drinking water standards
• The governing regulatory agencies with direct impact on water systems
• Analytical water grades (1, 2, 3) and reagent water types (I, II, III, IV, with A, B & C subgroups)
• Pharmacopeia water grades (Purified, Highly Purified, Water for Injection & Clean Steam)
• Pretreatment component equipment - selection and operating principals
• Final treatment options (reverse osmosis, vapor compression, single-effect and multiple-effect stills)
• Opportunities for energy and water resource conservation
• Point of use criteria such as temperature, location, time-of-day, and demand (GPM & GPD)
• System design including materials of construction, generation, storage and distribution options
• Trend reports (analysis, problem identification, predictive value)
• Control systems, data historian, secure access, set points and alarms
• Managing performance deviations and component failure
• Direct and in-direct impact analysis
• Quality by design including risk assessment
• Instrument calibration for critical, non-critical, and informational only devices
• Maintenance impacts to system performance, reliability, and validation
• The importance of as-built documentation - user and field directed changes

Who Should Attend

This course is designed for Regulatory, Quality, Compliance, Validation, R&D, Clinical, Manufacturing, Engineering, Maintenance, and Management personnel who are functioning as inspectors, auditors, investigators, sample analyzers, operators, and end-users as well as those in a project team or project management roles.

This two-day program will provide you with the training needed to enhance your understanding of water systems in terms of design, construction, commissioning, maintenance, and operations to ensure compliance with International Standards Organization (ISO) Criteria, Food and Drug Administration (FDA) Regulations and Guidance, United States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopoeia (JP), Clinical and Laboratory Standards Institute (CLSI), the American Society for Testing and Materials (ASTM), Good Engineering Practice and others.

Richard F. Newmiller