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Who should attend Effective Design, Validation and Routine Maintenance of Pharmaceutical Water
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
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Seminar Summary:

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. (see full course description)

 
 
 

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Training Course Syllabus:


Effective Design, Validation and Routine Maintenance of Pharmaceutical Water

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.
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.

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

Seminar Summary:

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. (see full course description)

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