Monitoring and Validation of Pharmaceutical Water Systems

This webinar will discuss the FDA requirements for design, validation and monitoring of pharmaceutical water systems. There are many different types of pharmaceutical waters and each must be fit for its intended use. Pharma water must be controlled for impurities. Pharma water systems must be designed, validated and monitored to ensure that the water produced meets specifications around the clock. Learn common pitfalls with water system design and use and how to avoid them. Get your pharma water questions answered in this webinar.

This presentation provides an overview on the different types of water systems used in the Pharmaceutical Industry. Attendees will be provided a comprehensive overview of the different types waters systems, their validation, and handling of excursions. We will also cover validation, monitoring, and analyzing data results. What data collected means, how excursions should be handled, and what actions can be done if a problem does occur? What can be expected when the water system is audited by regulatory bodies or clients?

Objectives of the Presentation:

  • Types of Water Systems used in the Pharmaceutical Industry
  • How pharmaceutical grade water is produced
  • Validating a newly commissioned Water System
  • Establishing procedures for maintaining the water system during its lifecycle
  • Quality Control Monitoring of the water system
  • Trending and presenting the results to auditors
Areas Covered in the Session :

  • Pharmaceutical water systems
  • Purification Process
  • Validation (IQ,OQ,PQ)
  • Daily monitoring requirements
  • Quality monitoring
  • Regulatory expectations
Who Should Attend:

  • Quality Assurance Departments
  • Quality System Auditors
  • Manufacturing Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Engineering Departments
  • Compliance Departments
  • Microbiology Analysts and Technicians
  • Lab Personnel
  • Logistics
  • Consultants

FDB2817

Carl Patterson

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.

To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called aseptic-process.net, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector. Recently, he is in the process of creating webinars so he can share pertinent information about pharmaceutical manufacturing from a microbiological perspective.

Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance