Event Detail
The A to Z’s of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems - US Seminar 2012 at Pennsylvania
April 19 - 20, 2012 - Pennsylvania, Courtyard by Marriott Philadelphia DE US
GlobalCompliancePanel
support@globalcompliancepanel.com
Phone: 8004479407
Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don’t work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur. Areas Covered in the Session: The "real" story behind some common water system design and control myths Biofilm properties, resistances, susceptibilities and examples Water system sanitization to control biofilm Water system microbial enumeration issues USP’s view on sampling and microbial enumeration Microbial enumeration options/advantages/disadvantages How to chose the best microbial enumeration method and "validate" it Water System Validation and Change Control Improving outcomes and reducing the frequency of excursion investigations How to perform successful Water System excursion investigations and troubleshooting, with case study examples What USP actually says about all this Who will benefit: This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the “true” whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are: Microbiology Laboratory supervisors and analysts responsible for water sampling and testing Quality Assurance personnel responsible for water system deviation management and change control Regulatory and Compliance professionals responsible for FDA interactions Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation Facility Engineers responsible for water system design or renovation Validation personnel for water system qualification Change Control personnel involved in water system changes and repairs Production Managers involved with water system use for manufacturing and cleaning Laboratory Managers and Supervisors responsible for lab water systems and other water sources