Validation

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Welcome to this short introduction to the contents of the presentation on

Validation

PresentationEze.com

This presentation provides information on

• the contents of the Validation Presentation – Section A (Pgs 2 – 19)

• ordering, cost & product delivery details – Section B (Pgs 20 – 23)

This presentation takes approximately 4 minutes to complete, alternatively you can manually advance.

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Section A – ValidationSummary of product contents:

• Introduction• Approach to Software Validation• Approach to Process Validation• Validation & Design Control• Which software, process, design systems need to be validated ?• Lifecycle Approach to Validation• - inc. Qualifications (IQ, OQ, PVS, PQ)• Documentation expectations• Approach to revalidation • The Validation Master Plan (VMP)• Other Validations• Validation in Regulated Industries• Protocol Reporting• When is a process considered Validated ?• Creating Compliant Validations • Quality Improvement techniques• Statistical techniques• References. Other sources of Information

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IntroductionIntroduction

• Why perform Product Validations? – Customer, regulatory, etc. expectations….– Business expectations….

• Quality System Requirements and Validations

• Effort versus Risk. Risk and Validation.

• Integration of Validation and Risk into the product life cycle, integration into the

Quality Management System

• Validation versus Verification

• International Standards and Validation requirements

• Definitions related to Validation

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Approach to Software ValidationApproach to Software Validation

• Guidance for Software Validations

• - GAMP Guide (Good Automated Practices)

• Categories of Software

• Software Life Cycle– User Requirements Specification– Functional Specification– Hardware Design Specification– Software Design Specification– Software Module Design Specification– Application Software Production– Module Software Test Specification– Integration Test Specification– Acceptance Test Specification– Verification Requirements & Design Specification– Verifying Test Steps, Expected Outputs and Evaluation Criteria

• Computer System Validation

• Electronic Records and Electronic Signatures

• Closed Software Systems, Audit Trail Requirements

• Extent of software validation to be performed

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Approach to Process ValidationApproach to Process Validation

• Focus on Production & Process Controls. (P&PC)

• P&PC – Objectives, Importance

• When to Validate a Process

• Examples of processes that should be Validated

• Examples of processes that may be Verified

• How do I know if a process cannot be fully Verified?

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Validation & Design ControlValidation & Design Control

• The Design Control Cycle

– User Needs

– Design Input

– Design Process

– Design Output

• Validation of the Design Process

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Which Systems need to be Validated?Which Systems need to be Validated?

• Validation should focus on the risk to an organization, it’s products, processes, customers, etc…

• Risk Approach to Validation. Why use Risk Assessment ?

– Cost Benefit of risk based approach

– Risk Management, Risk Evaluation, Risk Analysis, Risk Assessment

• Possible approach to Risk Assessment

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Life Cycle Approach to ValidationLife Cycle Approach to Validation

• Benefits of a Life Cycle Approach

• Functional Requirements

• System Specifications

• Installation Qualification (I.Q.)

• Example: GHIT Guide, 820.70 requirements

• Test types to be performed

• Example test details

• Operation Qualification (O.Q.)

• Example: GHIT Guide, 820.70 requirements

• Test types to be performed

• Example test details

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• Pre-Validation Study (PVS)

• Definition

• Tests (example) to be performed

• Performance Qualification (P.Q.)

• Definition

• Tests (example) to be performed

• Re-Qualification

• Change Control

• Quality Trending

Life Cycle Approach to Validation, Life Cycle Approach to Validation, con’t.con’t.

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Documentation ExpectationsDocumentation Expectations

• The necessity for documentation

• Types of documentation – specifications, non -conformance reports, change control forms, process protocols, etc.

• Standard Operating Procedures – writing, elements of, revision of,..

• Fundamental documentation rules

• Controlling official procedures

• Documentation retention requirements (regulated industries)

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Approach to RevalidationApproach to Revalidation

• Revalidation and changes

• Review and Evaluation of Revalidation

• Significance of “where appropriate” in revalidation

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Validation Master Plan (VMP)Validation Master Plan (VMP)

• VMP development process

• Why, Who, How, When & What

• Definition

• Why is a VMP necessary?

• Who prepares and approves the plan?

• How do you prepare & assemble a plan?

• Elements of a Validation Master Plan

• Post Validation project program descriptions

• Calibration

• Preventative Maintenance

• Training

• Change Control

• Document Control

• Re-qualification

• Implementation of the VMP

• Documenting the closure

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Other ValidationsOther Validations

• Fixture Qualification

• Definition

• Tests to be performed

• Component/material qualification

• Definition

• Content of procedure section

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Validation in Regulated IndustriesValidation in Regulated Industriese.g. Medical Devices, Pharmaceutical, Bio-Technology.e.g. Medical Devices, Pharmaceutical, Bio-Technology.

• Definitions

• Classification of products

• Classification rules

• Risk Assessment

• Specific requirements

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Protocol ReportingProtocol Reporting

• Definition

• Qualification Report Content

• Protocol Report summary

• Data Analysis Summary

• Exception statement

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When is a Process Considered Validated ?When is a Process Considered Validated ?

• Bringing all the elements together

• People requirements, e.g. training, independence,.. etc.

• Forward planning requirements

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Creating Compliant ValidationsCreating Compliant ValidationsQuality Improvement TechniquesQuality Improvement Techniques

Statistical TechniquesStatistical Techniques

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Quality Improvement TechniquesQuality Improvement Techniques

• Improvement process

• Define, Analyse, Root Cause, Solve, Monitor

• Brainstorming

• Process Flow charts

• Creating a Flowchart, Analysis

• Pareto charts

• Steps to construct, understanding,..

• Cause & Effect Diagrams

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Statistical TechniquesStatistical Techniques

• Introduction to Statistics/Histograms

• Mean, Mode, Range, Variance, Standard Deviation, how to construct Histograms, Normality, examples.

• Variable Control Charts

• X-Bar, R-Charts, Control Limits, Trends, Cause of out of control limits, Corrective Action.

• Gauge repeatability and reproducibility (R+R Studies)

• Gauge selection, why perform, when to perform, benefits, example.

• Capability analysis

• Advantages. Types. Cp, Cpk. Interpretation

• DPU charts

• Constructing DPU charts.

• Cycle time analysis

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Section B - Ordering and Cost

Ordering:• Orders can be made by credit card via secure Paypal. Just go to the Order page on

[ http://www.PresentationEze.com ].Alternatively, you can request an invoice, again please proceed to the Order Page.

Cost:• Each presentation currently costs $49. As the product is educational & training in nature, we must

insist on receipt of payment in advance of product dispatch.

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Section B - Product delivery details

Product details.

• The product is based on a PowerPoint format, providing ease of use and immediate familiarity where you have previous use of the Microsoft PowerPoint presentation product.

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• The product can be used by yourself for personal knowledge and training. You can share with your peers within your facility, again for their knowledge and understanding. You can place on a share file within your work facility. Additionally, you can use in classroom training, where you or your work peers use the slides as a basis for training presentations.

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Product delivery details, continued.

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Thank you.

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