1 / 8

Pharmaceutical Water Testing Program

Webinar on the types of pharmaceutical water systems, importance of the design of a water system as well as how the design affects successful validation.

compliancepanel
Download Presentation

Pharmaceutical Water Testing Program

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Pharmaceutical Water Testing Program www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  2. Instructor Profile: Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies. She has been a much sought after SME to assume key roles specifically related to remediation and difficult quality and compliance related deficiencies associated with FDA's Consent Decree, FDA's Warning Letters and other regulatory bodies' inspectional findings. Her remediation work has constantly resulted in several successful national and international regulatory bodies' inspections, re-inspections and new product approvals.  www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  3. Description: This webinar will help the attendee gain an understanding of the requirements of Pharmaceutical Water Systems per current USP <1231> 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 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.  www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  4. 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 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).  www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  5. Objectives of the Presentation: • Introduction to current USP <1213> Pharmaceutical Water System. • Planning the Design of a Water System • Routine Testing Types Associated with Water Testing Systems • Routine Testing Types Associated with Water Testing Systems • Non-routine Water Testing Program • Standard/General Practices for the Collection of Water Samples • Testing Time Frame • Water System Failures and Investigation • Water Testing Data Management and Trending. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  6. Who can Benefit: • Quality Control Analyst Personnel and Management • Senior Management • Manufacturing Associates Personnel and Management • Facility and Utility Personnel and Management • Quality Assurance Analyst Personnel and Management • Vendors and Suppliers of Pharmaceutical Water Systems and Peripherals • Regulatory Affairs and Personnel Management • Shipping and Receiving Personnel and Management • Materials Handling Personnel and Management • Supplier Quality Personnel and Management • Site Director • Operations Director & Others. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  7. Live Session - How it works • Username and Password will be sent to you 24 hours prior to the webinar • Presentation handouts in pdfformate will be mailed to you • Login to the session using the username and password provided to you • Get answer to your queries through interactive Q&A sessions via chat • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve • Get certification of attendance. Recorded Session - How it works • A link will be provided to you upon purchase of the recorded session • Please click on the link to access the session • Presentation handouts in pdfformate will be mailed to you • Get certification of attendance. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  8. Get Connected : www.onlinecompliancepanel.com www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

More Related