Pharmaceutical Water Testing Program

Description:
This webinar will help the attendee gain an understanding of the requirements of Pharmaceutical Water Systems per current USP Water for Pharmaceutical Purposes. This webinar 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 webinar 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 webinar 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.

Why Should you Attend:
Pharmaceutical water systems such as Water for Injection (WFI), Clean Steam, RO/DI, Distilled, Milli-Q and other water systems are critical to routine manufacturing of product as well as for use within the Clean Room (Room Disinfection). Some water systems are also used to generate feed water that eventually forms the final WFI which is critical to the manufacturing of product. Some manufacturers have found themselves having issues and water system failures long after the water systems have been designed.

Difficulties such as; Inability to validate the water system due to design issues, difficulty in maintaining a low level of bio-burden within the water system due to dead legs (i.e. Biofilms formation), difficulty in maintaining acceptable limits for applicable water testing programs. Difficulties and associated water failures and investigations, have led to several product manufacturing delays due to inability to use the affected water for the manufacturing of product as well as for their Clean Room operation (i.e. several water testing investigations). The cost associated with failure investigation, failed water systems and impact to the manufacturer operation is high hence having a good knowledge of these requirements and how to apply it to new or existing water systems will benefit the attendee.

Objectives of the Presentation:
This webinar will provide a great resource to Pharmaceutical, Biotechnology and Medical Device Industries that have an existing pharmaceutical water system, plan to start a new design or modify an existing water system or plan to modify a water testing program to meet the USP or FDA requirements.
Introduction to current USP Pharmaceutical Water System.
Applicable Regulation and Requirements.
Scope of the Different Water Systems:
Water for Injection (WFI)
Clean Steam
RODI
Milli-Q
Potable/City water
Planning the Design of a Water System
Best Practices during the design planning phase.
Critical Points to Consider and Impact to Validation and Routine Testing Program.
Planning the Validation of a Water System:
Points to consider when planning a utility validation protocol
Points to consider when planning the number of sample points, days and types of tests
Routine Testing Types Associated with Water Testing Systems
Bioburden Testing
Endotoxin Testing
Nitrates Testing
Heavy Metals Testing
Total Organic Carbon (TOC)

About Company:

Online Compliance Panel creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. Online Compliance Panel largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

Contact:
Toll free: +1-510-857-5896
Email: [email protected]
OnlineCompliancePanel LLC,
38868 Salmon Ter,
Fremont, CA 94536, USA
Use For Registration: http://bit.ly/Pharmas