Computer Validation CONTENT Power Package

This package contains 10 items including: 2 webinar recordings, 3 pdf powerpoint training presentations (60+ slides), 2 trainer instructional notes, 3 reference articles (30+ pages):

➢1. Computer Validation Regulatory Documents Explained: The Basics (Reference article)

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➢2. Computer Validation Regulatory Documents Explained: The Basics (PDF PowerPoint Training Presentation)

➢3. Computer Validation Regulatory Documents Explained: The Basics (Trainer Instructional Notes)

➢ 4. Requirements: Your Foundation for Conducting Successful Computer Systems Validation (One Hour Webinar Recording)

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➢ 5. and 6. Requirements: Your Foundation for Conducting Successful Computer Systems Validation (PowerPoint Training Presentation and Trainer Instructional Notes)

➢ 7. Considerations in Writing More Effective Computer Validation Requirements (Article)

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➢ 8.Computer Validation Audits: A Primer for Successful Execution (One Hour Webinar Recording)

➢ 9.Computer Validation Audits: A Primer for Successful Execution (PowerPoint Training Presentation)

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➢ 10. Spreadsheet Validation: Critical Considerations (Article and Checklist)

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1. Computer Validation Regulatory Documents Explained: The Basics (Reference article)

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In this 14 page article, we define the basic types of regulatory documents related to matters of quality assurance and computer validation, and attempt to characterize their anatomy, structure, organization and content, so that they can be better understood by those who use them. Hopefully, once we have a better understanding of our documents and the purpose they serve, we will find them more useful and easier to create, review, modify and maintain.

➢ Statement documents

➢ Policies

➢ Acceptable use policy

➢ Interpretations and rationale

➢ Process-related documents

➢ Procedures

➢ Work instructions

➢ Detailed forms and templates

➢ Work products

➢ Supporting documents

➢ Guidelines

➢ Standards

➢ Regulations

Several charts and diagrams are included in this article, including:

➢ A framework for discussing different types of regulatory documents

➢ Sample policy statements for specific topic areas

➢ Sample interpretation of a company policy and corresponding rationale

➢ A typical process flow diagram for computer system validation

➢ Recommended elements of an SOP

➢ Examples of work products that are records

➢ Alignment of lifecycle phases with work products (document deliverables)

➢ The first and last validation work products (the “bookends”)

➢ Relationships between document types

➢ Summary table divided into document type, example, typical owner(s), purpose and qualities

2. and 3. PDF PowerPoint Traingng Presentation and Trainer Instructional Notes

16 slide PDF PowerPoint Training Presentation. Based on the subject matter presented in the reference content article series above. This PDF readymade presentation provides “core” subject matter content, and allows you to customize specific information within your presentation.

Trainer instructional notes, which contain 30+ discussion points related to the PowerPoint training presentation, are also included. Trainer instructional notes are designed to help focus your presentation on key points, engage attendees and encourage their participation in your training.

4. 5. and 6.  Requirements: Your Foundation for Conducting Successful Computer Systems Validation (One Hour Webinar Recording, PowerPoint Training Presentation and Trainer Instructional Notes)

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Serves as an invaluable guide to critical aspects of defining and developing a requirements specification related to conducting effective computer systems-related validations.

“Requirements are the single most fundamental part of a computer system validation project, as they determine the scope, level of effort, schedule and resources that will need to be involved in the validation.”

Subject matter content reviewed includes:

➢ Computer system definition

➢Computer system validation lifecycle

➢Why requirements

➢Planning is everything

➢Requirement types

➢Requirements definition

➢Fundamental qualities of requirements

➢Requirements language

➢Requirements analysis

➢Sources of requirements

➢Factors influencing requirements

➢Contributors

➢Creating (or extracting) requirements

➢Risk implications

➢Traceability

➢Change control

➢Configuration management

Instructors: Jay King, Senior Manager, Software and New Product Quality at LifeScan, a Johnson & Johnson Company

John Janeri, President, Compliance House, Inc.

*Powerpoint Presentation Notes are comprehensive. Reads like a reference article.

7. Considerations in Writing More Effective Computer Validation Requirements (Article)

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This eight-page article reviews a number of critical issues related to writing effective computer validation requirements. Several examples are presented throughout the article. Subject matter content includes:

➢Structuring requirements

➢Level of detail

➢Pseudo-code

➢Intended use

➢Diagnostics

➢Quality content

➢Design input/automated processes

➢Relationship of requirements

➢Indicating where requirements are met

8. and 9. Computer Validation Audits: A Primer for Successful Execution (One Hour Webinar Recording and PowerPoint Training Presentation)

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Eric Henry, former Sr. Manager, Corporate Software Quality, Boston Scientific, reviews the following subject matter content in this one hour long webinar:

➢ Software validation in an FDA-regulated company

➢ What do I want to know?

➢ Can just anyone perform an audit?

➢ What do I audit?

➢ The pre-review

➢ In the room Q&A, roles & tips, the players

➢ What do I say about what I saw?

➢ Addressing the findings (…or damage control)

10.  Spreadsheet Validation: Critical Considerations (Article and Checklist)

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This article provides specific areas of consideration and useful tips for conducting a spreadsheet validation. Areas reviewed include:

➢Scoping (a list of 21 questions to ask)

➢Risk assessment

➢Standards

➢Validation process flow (chart included)

➢Requirements

➢Development

➢IQ/OQ/PQ

➢Version control for development

➢Change control

A generic controlled document checklist for spreadsheet validation is included.

Computer Validation CONTENT POWER Package is now only $159.00