New Pharma Water and Lab Water Systems Details

All Pharmaceutical products and R&D require USP and FDA Pharmaceutical Grades of Water. The Water is used as an ingredient, cleaning manufacturing equipment and a key ingredient for Quality testing. If a company cannot meet, maintain and demonstrate the Water Standards legally required, they cannot sell their products.

Just as the Water has Standards, the Project to install a Pharma Water System has specific FDA requirements for it to meet before it can be placed into use.

This Webinar will review the many steps of starting, installing, Validating and Testing before it can be approved for use. This knowledge should expedite the time and work required to place a New System into use.

Areas Covered in the Session :

• Project Planning
• The location and site analysis.
• Determining Available utilities capacities
• Initial Preliminary Layout.
• Preliminary Budget and Project Schedule.
• When the real Project work starts.
• Selection of System Designers
• Determining Working with Production of the Water System Generation capacity, Storage Tank capacity, Water distribution routing and other details.
• Many more details and options will be developed which will be covered in the Presentation.
• Placing the Water System into Production.
• The first year of operation requirements.

Who Should Attend:

• Quality Departments
• Project Engineers
• Plant Personnel
• Project Designers and contractors
• Production Departments
• Regulatory Departments
• Water Systems Maintenance Departments
• Quality Sampling and Testing Teams

Course Director: PETER VISHTON

Peter is an Independent Pharmaceutical Water Systems Consultant working with several companies. He has 25 years of experience in the Pharmaceutical area which includes 10 years with Pharmaceutical Water Systems. Peter’s experience includes being a member of GMP Teams to Design / Construct / Start Up /Commission and Qualify new or expanded pharmaceutical facilities. These were GMP Production spaces, Manufacturing Equipment, Utilities and their Control Systems. Among the assignments were Parenterals, Biologics, OSD and their Pharmaceutical production rooms and equipment. The utilities and facilities Validation documentation were included and lead to the completion of Validation and initial production batches. Peter completed his Bachelor’s Degree and his Master of Environmental Management Degree from Drexel University. He is an active ISPE member that participates in current and new technology publications and forums assuring current knowledge of industry practices in GMP Manufacturing, Clean Utilities, Quality and FDA guidance. He has been a contributing author on all the ISPE Communities of Practice Publications for GMP Pharmaceutical Water, Steam and Compressed Gasses where he worked with Industry Experts.