Pharmaceutical Water Testing Program

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Pharmaceutical Water Testing Program
www.onlinecompliancepanel.com 510-857-5896
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• 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
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• Description
• This webinar will help the attendee
  gain an understanding of the requirements of
  Pharmaceutical Water Systems per current USP
  lt1231gt 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
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• 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). 

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• Objectives of the Presentation
• Introduction to current USP lt1213gt 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.

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• 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.

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• Live Session - How it works
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf formate will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA 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 pdf formate will be
  mailed to you
• Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com