ComplianceOnline
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.

Why You Should 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 cleanroom (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.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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 bioburden 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 cleanroom 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.

Learning Objectives:

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
  • Shipping and Receiving Personnel and Management
  • Facility and Maintenance Personnel and Management
  • Microbiologist Personnel and Management
  • Engineering Personnel and Management
  • Materials Management Personnel and Management
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Day 01(8:30 AM - 5:00 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • 9:00am – 10:00am
    • Regulations Guiding Pharmaceutical Water
    • Introduction to current USP <1213> Pharmaceutical Water System
      • Applicable Regulation and Requirements
    • Types and Uses of the Different Pharmaceutical Water Systems:
      • Water for Injection (WFI)
      • Clean Steam
      • RODI
      • Milli-Q
      • Potable/City water
    • Planning the Design of a Pharmaceutical Water System
      • Best Practices during the design planning phase
      • Critical Points to Consider and Impact to Validation and Routine Testing Program
    • Evaluating the Needs Prior to Choosing a Design
      • What to look for during this evaluation phase.
      • Needs versus Compliance Based Approach.
      • Understanding your product type.
      • Understanding your capabilities
      • Understanding your products or processes.
      • Understanding the impact to other operations and infrastructure.
      • Cost versus Benefits
    • Evaluating the Supplier or Vendor of the Pharmaceutical Water System
      • Making the right choice
      • What to look for when choosing a pharmaceutical water system supplier or vendor
      • Quality and Compliance, Customer Service or Both
      • Supplier’s Role in the Evaluation Process
  • 10:00am - 10:15am (Break)
  • 10:15am – 11:00am
    • The Initial Design Planning Phase
    • Who to include when planning a Pharmaceutical Water system
      • Impacted departments
      • Impacted operations
      • Impacted Operations and Processes
      • Involving the Impacted Department.
      • Involving the Quality Organization and Testing Operations
    • Seeking Feedback from Stakeholders
    • Weigh the Pros and Cons
    • Gather Ideas
    • Placing Ideas on Paper and Design Drawing
    • Comparing Design with other Possible Impacted or Related Systems
  • 11:00am - 12:00pm
    • Choosing the Water System Type and Design
      • Using ideas and decisions to design the Water system.
      • Verifying functionality/how to determine a good design
      • Compare design with validation plans
      • Compare Water design with current infrastructure to determine impact
      • Address all possible impact
      • Involve Facilities and Engineering
      • Put design on paper and evaluate feasibility of design with the planned validation and routine testing
  • 12:00pm - 1:00pm (Lunch)
  • 1:00pm – 2:00pm
    • Validating Pharmaceutical Water
      • Planning the Water System Validation
      • Designing the Water System Validation Protocol to meet regulations.
      • What to include in a robust pharmaceutical Water system validation protocol
      • Deciding on what use points, number of testing days and types of test to perform.
      • Setting the test specification or acceptance criteria (action levels)
      • Reviewing and approving the protocol.
      • Who should review and approve the validation protocol
  • 2:00pm – 3:00pm
    • Validating Pharmaceutical Water contd.
      • Designing a Pharmaceutical Water System Validation Report.
      • What to include in the Pharmaceutical Water system validation report.
      • Data management of Pharmaceutical Water system validation result.
      • Translating the Pharmaceutical Water validation data into routine monitoring of the Water.
      • Handling out of specifications or deviations during the Pharmaceutical Water system validation.
      • Approving the Pharmaceutical Water system validation report.
  • 3:00pm - 3:15pm (Break)
  • 3:15pm - 4:00pm
    • Drafting Associated Standard Operating Procedures or Standard Test Methods
      • SOPs or STMs must be approved prior to routine monitoring and testing.
  • 4:00pm – 5:00pm
  • Case Studies and Questions/Answers
Day 02(8:30 AM - 5:00 PM)
  • 8:30am - 9:00am (Registration)
  • 9:00am – 10:00am
    • Routine Testing Programs for Pharmaceutical Water (Post Validation)
      • Designing a Routine Pharmaceutical Water Testing Program
      • How to Transition from the Validation Phase into Routine Monitoring of Water
      • Understanding what to include in the routine Water testing program
      • Types of pharmaceutical Water testing programs
      • Defining Pharmaceutical Water Testing Frequencies and Specifications
    • Microbiological Monitoring and Testing Programs for Pharmaceutical Water
      • Routine Testing Types Associated with Water Testing Systems
        • Bioburden Testing
        • Endotoxin Testing
        • Nitrates Testing
        • Heavy Metals Testing
        • Total Organic Carbon (TOC)
        • Conductivity
        • Coliform Testing
        • Chlorine Content
    • Non-routine Pharmaceutical Water Testing Program
      • What is a Non-routine Pharmaceutical Water Testing Program
      • When to Perform a Non-routine Pharmaceutical Water Testing
      • Types and Frequency of Testing for Non-routine Purposes
    • Defining the Water Testing Specifications
      • Points to Consider When Setting Limits and Specification for the Different Types of Pharmaceutical Water Systems
        • Alert Versus Action Levels
        • Different Water Systems and Applicable Alert or Action Limits
        • Routine Re-evaluation of Alert or Action Limits
        • When and How to Modify an Alert or Action Limits
  • 10:00am - 10:15am (Break)
  • 10:15am – 11:00am
    • Best Practices to consider when testing pharmaceutical Water.
      • Aseptic techniques
      • Appropriate gowning practices
      • Sampling materials
      • Disinfection practices
      • Outlets and locations
      • Avoiding Common Mistakes
  • 11:00am – 12:00pm
    • Standard/General Practices for the Collection of Water Samples
      • Appropriate Sampling Procedures for Different Water Systems
      • Points to Consider for Collecting Water Specific to the Following Types of Tests
        • Total Organic Carbon (TOC)
        • Conductivity
        • Endotoxin
        • Bioburden
        • Heavy Metals and Nitrates
        • Chlorine
    • Testing Time Frame
      • What is the Acceptable time frame?
        • From sampling through testing of the collected water
      • Compliance Challenges Associated with non-validated hold times for sampled water.
      • Hold Time Studies for Sampled Pharmaceutical Water - Prior to Testing
    • Pharmaceutical Water Failure and Contamination Investigation Process
      • Types of Pharmaceutical Water Failures and Contamination
      • Out-of-specification Investigation (Alert and Action Levels Excursions)
      • Reasons for Water System Failures and Excursions
      • Guidance on Alert and Action levels excursion investigation.
      • Guidance for when those Alert and Action levels are exceeded.
      • Water system(s) deviation or excursion investigation.
    • Water System(s) re-certification procedure
      • Expectation for routine maintenance of water systems
        • When and How to Perform a Water System Re-certification
        • What happens after a long shut-down of a water system
        • Water system(s) maintenance procedure
  • 12:00pm - 1:00pm (Lunch)
  • 1:00pm - 2:00pm
    • Investigating a Pharmaceutical Water Testing Failure or Contamination
      • How to initiate a pharmaceutical Water system failure investigation
      • What to include in a pharmaceutical Water system failure investigation
      • What to verify, evaluate and eliminate during the investigation
      • How to document the pharmaceutical Water system failure investigation
      • How to Disposition the Impacted Batch or Product Affected by pharmaceutical Water testing failure.
      • Common mistakes made during a pharmaceutical Water testing failure investigation
    • Remediation of Pharmaceutical Water System Failures
      • Performing remediation activities associated with Pharmaceutical Water Systems
      • Return to use processes and testing activities after the failure of the water system
      • Routine Preventative Maintenance Programs
  • 2:00pm - 3:00pm
    • Water Testing Data Management and Trending
      • Effectively using test data derived from Pharmaceutical Water Testing Program
      • Data management of Pharmaceutical Water Testing Program
      • Trending of Pharmaceutical Water Testing Data- Applying the Results
      • Routine Testing of Pharmaceutical Water Systems –Post-validation Testing
  • 3:00pm - 4:00pm
    • Review of Case Studies - FDA Recent Form 483 Applicable to Pharmaceutical Water
      • Case Study #1 – FDA Form 483 Associated with Pharmaceutical Water Systems
      • Case Study #2 - FDA Form 483 Associated with Pharmaceutical Water Systems
      • Case Study #3 - FDA Form 483 Associated with Pharmaceutical Water Systems
        • How to Address Compliance Issues
        • Compliance Implications
        • Impact to Product/Batch
        • Production Costs
        • Impact to the Production Process
  • 4:00pm - 5:00pm
    • Question and Answer Session
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Charity Ogunsanya

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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