Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam

Date : 25th March 2021 to 25th March 2021

Place : United States, East Camden

Website :https://worldcomplianceseminars.com/

Contact Person:WCs Conference

Description:

Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product. The well-being of a facility revolves around the health of each water system within that facility. How often have we learned of a facility being closed for weeks at a time because of a water system that has exceeded its microbiological specifications? This live, interactive ECS training webinar presentation will also examine a variety of the issues surrounding water in a facility to include the testing of each water source and to what extent. It will cover testing requirements during commissioning and testing on an on-going basis. The webinar will examine Quality Risk Management (ICH Q9) and discuss how a properly developed Facility Water Validation Plan may lead to a logical, reduced requirement for testing vs. time. The presentation will explore the time requirement for testing before reduced testing might occur and why some organizations refuse to accept this path. The objective of this live and interactive ECS webinar is to assist those involved in the development of a process or the manufacturing of a product to explore water, as a raw material (component) in a GMP environment, the requirements for potable water, purified water, water for injection and steam to assure that they are meeting the current USP, EP, JP and FDA requirements. Please plan to have a Project team attend to gain the most from this webinar.

Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam will be held in East Camden,United States on date 2021-03-25

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Deadline for abstracts/proposals : 25th March 2021

Keynote Speakers : Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena.

Conference Highlights :How to set up a water sampling system and its test frequency. Determining the “Health” of a water system based upon test results. What are the differences between USP, EP and JP water requirements The use of Alert and Action Levels vs. Specifications and what is meant by each. When should microorganisms be identified and the preferred methods. Understanding the requirements for in-house vs. purchased water. Determination of various validations that supplement the maintenance of a USP

Check the event website for more details.