San Francisco, California
London, United Kingdom
This seminar will help the attendee gain an understanding of the requirements of Pharmaceutical Water Systems per current USP <1231> Water for Pharmaceutical Purposes. This seminar will describe the different types of pharmaceutical water systems, the importance of the design of a water system and applications as well as how the design relates to and affects the successful validation and future routine testing. This seminar will also guide a drug product manufacturer with a new or existing water system about the appropriate types of routine testing frequency, types of testing as well as how to set an acceptable alert and action levels for the different water systems. This seminar will also cover water test result/data management and trending in order to guide the user about the best way to have a steady state of control of the different water system. This will help the user or manufacturers to avoid future pharmaceutical water failure investigation or inability to validate or get a good test results from the new water system due to design related issues.
This seminar will enhance the attendee skills in the following areas:
- Understand the applicable regulations, types of water and the routine testing requirements associated with pharmaceutical water systems.
- Plan, define, design, and validate the various types of pharmaceutical water systems using a compliant validation protocol.
- Define and understand the different types of tests, testing frequencies, sampling procedures associated with the various types of pharmaceutical water systems.
- Set the appropriate testing specifications (alert and action levels) for various types of pharmaceutical water systems.
- Perform routine recertification of water systems, re-testing and re-evaluation of an alert or action limit associated with the various types of pharmaceutical water systems.
- Disposition an impacted manufactured product manufactured using pharmaceutical water with an out of specification or failure result.
- How to perform routine pharmaceutical water system result data management and trending.
Who Will Benefit:
This seminar will benefit those involved in manufacturing, using, testing and Validating pharmaceutical water systems in various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries, especially:
- Quality Assurance Personnel and Management
- Quality Control Personnel and Management
- Laboratory Managers
- Testing Analysts and Technicians
- Manufacturing Personnel and Management
- Suppliers and Vendors of Pharmaceutical Water Systems
- Validation Personnel and Management
- Supplier Quality Assurance Personnel and Management
- Regulatory Affairs Personnel and Management
Note: Use coupon code NB5SQH8N and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.