Pharmaceutical Water System: Design, Testing and Data Management

Charity Ogunsanya

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In this pharmaceutical water system webinar attendees will learn how to design, validate and maintain the new and existing water systems used in drug product manufacturing process. Different types of routine tests, testing frequencies, actions in each tests and sampling procedures associated with pharmaceutical water systems will be discussed to avoid any water systems failures.

Why Should You Attend:

This 90-minute training will guide a drug product manufacturer with effectively designing, validation and maintaining a new or existing water system. The appropriate design planning considerations, validation, types of routine tests, testing frequencies, water system maintenance and how to set an acceptable alert and action levels will be reviewed. Water test result/data management and trending which will be a guide to a steady state of control of the different water systems will be presented. This will benefit the manufacturers by helping to avoid future costly pharmaceutical water systems failure, investigations or inability to validate or achieve passing test results from a new or existing water systems emanating from design-related issues..

Learning Objectives:
Upon completion of this course you will be able to:
  1. List the applicable regulations and types of pharmaceutical water systems.
  2. Plan, define, design, and validate the various types of pharmaceutical water systems using a compliant validation protocol.
  3. Define and describe the types of routine tests, testing frequencies and sampling procedures associated with Pharmaceutical Water systems.
  4. Describe and define how to set the alert and action levels test specification for each type of test.
  5. Perform routine recertification of water systems, re-testing and re-evaluation.
  6. Perform test data management and trending.

Areas Covered in the Webinar:

Module 1:

  • Introduction to current USP <1213> Pharmaceutical Water System
  • Scope of the Different Water Systems
  • Planning the Design of a Water System
  • Planning the Validation of a Water System

Module 2:

  • Routine Testing Types Associated with Water Testing Systems
  • Non-routine Water Testing Program
  • Defining the Water Testing Specifications
  • Standard/General Practices for the Collection of Water Samples
  • Testing Time Frame

Module 3:

  • Water System Failures and Investigation
  • Water System(s) re-certification procedure
  • Water Testing Data Management and Trending
  • Data Trending of Routine Water Testing
Who Will Benefit:

This training will be beneficial to professionals in the Pharmaceutical, Cell Therapy, Diagnostics, Biologics, Biotechnology and Medical Device Industries. The employees who will benefit most include personnel and management within:

  • Quality Control Analyst
  • Manufacturing Associates
  • Facility and Utility
  • Quality Assurance Analyst
  • Vendors and Suppliers of Pharmaceutical Water Systems and Peripherals
  • Regulatory Affairs
  • Shipping and Receiving
  • Materials Handling
  • Supplier Quality
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Charity Ogunsanya, CEO and Founder, Pharmabiodevice Consulting LLC

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.

Her technical expertise covers and goes beyond interpretation, administration and set up of quality assurance, quality/compliance, quality engineering, aseptic processing, contamination control, quality control, microbiology, sterility assurance, stability, vaccine development, new product design, product release testing and medical device sterilization (ethylene oxide (EtO), gamma, radiation, VHP sterilization) systems and operations for compliance to various regulations.

She has a keen working knowledge of the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization and post-approval inspections.

She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and she is currently attaining her Masters in Biotechnology (Biodefense Concentration) at the Johns Hopkins University Advanced Academic Program.

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