Instructor :
Carolyn Troiano

Webinar ID:
11407

Bootcamp Objective: Step into the world of Computer System Validation (CSV) and discover how effective validation can streamline your operations, boost efficiency, and minimize risks.

Gain practical skills that translate directly into smoother processes, less downtime, and enhanced operational success.

What You’ll Learn:

• • Dive into real-world case studies and engaging discussions to build CSV expertise.
  • Understand key FDA regulations impacting pharmaceutical, biotechnology, medical devices, and other FDA-regulated industries.
  • Learn how to plan, implement, test, and manage systems handling critical data, ensuring regulatory compliance.

Why It Matters:

• • The FDA has regulated CSV for over 30 years, emphasizing data integrity in all FDA-regulated environments.
  • Stay current with 21 CFR Part 11, which governs Electronic Records and Electronic Signatures (ER/ES). Master the documentation and validation requirements to meet FDA standards.
  • With the FDA’s shift towards risk-based self-assessment, learn to develop a robust validation strategy that addresses potential system risks.

Key Focus Areas:

• • Testing Scope: Understand the five critical testing factors—system size, complexity, business importance, GAMP 5 category, and risk rating.
  • Data Integrity: Master techniques to ensure compliance for systems that create, collect, analyze, manage, transfer, and report data.

In This Interactive Bootcamp, You’ll:

• • Explore best practices for assessing computer systems in FDA-regulated environments.
  • Analyze the impact of system failures on data integrity, product quality, and consumer safety.
  • Gain a deep understanding of the System Development Life Cycle (SDLC) with a focus on risk assessment.
  • Master 21 CFR Part 11, managing electronic records and signatures to ensure compliance.
  • Learn essential policies, procedures, and documentation needed to pass FDA inspections.
  • Prepare for audits of computer hardware, software, and service vendors.
  • Excel in GxP roles with a strong foundation in industry standards and risk evaluation.

This 12-hour intensive bootcamp is perfect for professionals in regulated industries who want to elevate their skills and ensure compliance with FDA guidelines. Whether you’re a CSV beginner or looking to advance your expertise, this training is designed to provide actionable insights and practical skills.

Enroll Now and take control of your CSV journey with confidence and expertise!

Bootcamp Objective: Step into the world of Computer System Validation (CSV) and discover how effective validation can streamline your operations, boost efficiency, and minimize risks.

Gain practical skills that translate directly into smoother processes, less downtime, and enhanced operational success.

What You’ll Learn:

• • Dive into real-world case studies and engaging discussions to build CSV expertise.
  • Understand key FDA regulations impacting pharmaceutical, biotechnology, medical devices, and other FDA-regulated industries.
  • Learn how to plan, implement, test, and manage systems handling critical data, ensuring regulatory compliance.

Why It Matters:

• • The FDA has regulated CSV for over 30 years, emphasizing data integrity in all FDA-regulated environments.
  • Stay current with 21 CFR Part 11, which governs Electronic Records and Electronic Signatures (ER/ES). Master the documentation and validation requirements to meet FDA standards.
  • With the FDA’s shift towards risk-based self-assessment, learn to develop a robust validation strategy that addresses potential system risks.

Key Focus Areas:

• • Testing Scope: Understand the five critical testing factors—system size, complexity, business importance, GAMP 5 category, and risk rating.
  • Data Integrity: Master techniques to ensure compliance for systems that create, collect, analyze, manage, transfer, and report data.

In This Interactive Bootcamp, You’ll:

• • Explore best practices for assessing computer systems in FDA-regulated environments.
  • Analyze the impact of system failures on data integrity, product quality, and consumer safety.
  • Gain a deep understanding of the System Development Life Cycle (SDLC) with a focus on risk assessment.
  • Master 21 CFR Part 11, managing electronic records and signatures to ensure compliance.
  • Learn essential policies, procedures, and documentation needed to pass FDA inspections.
  • Prepare for audits of computer hardware, software, and service vendors.
  • Excel in GxP roles with a strong foundation in industry standards and risk evaluation.

This 12-hour intensive bootcamp is perfect for professionals in regulated industries who want to elevate their skills and ensure compliance with FDA guidelines. Whether you’re a CSV beginner or looking to advance your expertise, this training is designed to provide actionable insights and practical skills.

Enroll Now and take control of your CSV journey with confidence and expertise!

In today’s highly regulated environment, effective Computer System Validation (CSV) is no longer optional—it’s critical.

This 2-day intensive boot camp is designed to empower you with the latest skills, techniques, and best practices to ensure compliance, data integrity, and operational excellence.

Here’s why you can’t afford to miss it:

• • Stay Ahead of Regulatory Changes: Align your validation practices with FDA, ICH, and Eudralex standards, including 21 CFR Part 11 and Annex 11. Be prepared for FDA inspections and ensure your systems meet the latest compliance requirements.
  • Practical, Ready-to-Use Tools: Learn using standard operating procedures (SOPs) and validation templates that have been successfully implemented by other enterprises. Walk away with practical tools you can immediately apply within your organization.
  • Enhance Your Validation Efficiency: Master risk-based validation techniques that streamline processes, reduce downtime, and boost efficiency. Discover how to apply the System Development Life Cycle (SDLC) approach to CSV, optimizing your validation activities.
  • Overcome Real-World Challenges: Gain insights into validation strategies for various applications like Cloud/SaaS, spreadsheets, and custom systems. Learn how to address common pitfalls and ensure continuous system validation throughout its lifecycle.
  • Build a Robust Validation Rationale: Understand how to conduct comprehensive risk assessments and develop a well-founded validation strategy. Focus on system size, complexity, business importance, GAMP 5 category, and potential risks to ensure inspection-readiness.
  • Protect Data Integrity: Learn strategies to safeguard the integrity of GxP data across the data lifecycle. Understand the documentation requirements for maintaining validated systems, ensuring your data remains secure and compliant.
  • Excel in Your GxP Role: Enhance your expertise in GxP-related roles by mastering documentation best practices, validation methods, and audit readiness. Stand out as a CSV leader within your organization, driving innovation and quality compliance.

Join our Boot Camp to Demystify CSV:
Gain the knowledge and confidence to navigate the complexities of CSV and position your organization at the forefront of compliance and quality standards. Whether you’re a beginner or looking to deepen your expertise, this course is tailored to provide actionable insights that will advance your career and skills.

Enroll Now! Don’t miss this opportunity to become a CSV expert and take your validation processes to the next level.

In today’s highly regulated environment, effective Computer System Validation (CSV) is no longer optional—it’s critical.

This 2-day intensive boot camp is designed to empower you with the latest skills, techniques, and best practices to ensure compliance, data integrity, and operational excellence.

Here’s why you can’t afford to miss it:

• • Stay Ahead of Regulatory Changes: Align your validation practices with FDA, ICH, and Eudralex standards, including 21 CFR Part 11 and Annex 11. Be prepared for FDA inspections and ensure your systems meet the latest compliance requirements.
  • Practical, Ready-to-Use Tools: Learn using standard operating procedures (SOPs) and validation templates that have been successfully implemented by other enterprises. Walk away with practical tools you can immediately apply within your organization.
  • Enhance Your Validation Efficiency: Master risk-based validation techniques that streamline processes, reduce downtime, and boost efficiency. Discover how to apply the System Development Life Cycle (SDLC) approach to CSV, optimizing your validation activities.
  • Overcome Real-World Challenges: Gain insights into validation strategies for various applications like Cloud/SaaS, spreadsheets, and custom systems. Learn how to address common pitfalls and ensure continuous system validation throughout its lifecycle.
  • Build a Robust Validation Rationale: Understand how to conduct comprehensive risk assessments and develop a well-founded validation strategy. Focus on system size, complexity, business importance, GAMP 5 category, and potential risks to ensure inspection-readiness.
  • Protect Data Integrity: Learn strategies to safeguard the integrity of GxP data across the data lifecycle. Understand the documentation requirements for maintaining validated systems, ensuring your data remains secure and compliant.
  • Excel in Your GxP Role: Enhance your expertise in GxP-related roles by mastering documentation best practices, validation methods, and audit readiness. Stand out as a CSV leader within your organization, driving innovation and quality compliance.

Join our Boot Camp to Demystify CSV:
Gain the knowledge and confidence to navigate the complexities of CSV and position your organization at the forefront of compliance and quality standards. Whether you’re a beginner or looking to deepen your expertise, this course is tailored to provide actionable insights that will advance your career and skills.

Enroll Now! Don’t miss this opportunity to become a CSV expert and take your validation processes to the next level.

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

DAY 1 & 2 : 6-Hrs each day

Module 1: Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology

• • FDA Compliance and Guidance
  • Other Regulations and Guidance (EMA, EU, MHRA)
  • Exercise: Exploring the Regulations using the fda.gov website

Module 2: CSV Methods and Models

• • GxP Systems
  • Computer System Validation (CSV)
  • Validation, Verification, and Qualification
  • Common SDLC Methodologies
  • GAMP 5 “V” Model

Module 3: Software and Services

• • Computer Off-the-Shelf (COTS) Software
  • Cloud Systems
  • FDA’s “Case for Quality”
  • Software as a Service (SaaS)
  • Case Study: Cloud SaaS
  • Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
  • Single Sign On (SSO)
  • Medical Devices and Software as a Medical Device (SaaMD)
  • Software Quality Assurance (SQA) Plan
  • Mobile Devices and Medical Application
  • Spreadsheet Validation

Module 4: 21 CFR Part 11, FDA’s Guidance for ER/ES

• • 21 CFR Part 11 Guidance
  • Electronic Records/Signatures (ER/ES) Requirements
  • Exercise: FDA Guidance for ER/ES
  • Vendor Audit

Module 5: Data Integrity and Governance

• • Data Life Cycle Approach
  • Data Integrity
  • Data Governance

Module 6: CSV Planning

• • Validation Strategy Document (VSD)
  • Validation Strategy Components
  • Rationale for Validation Testing
  • GAMP 5 System Categorization

Module 7: CSV Supporting Components

• • Good Documentation Practices (GDPs) Training
  • Organizational Change Management (OCM)
  • CSV Policies and Procedures

Module 8: Risk-Based CSV

• • Risk Assessment
  • Risk Mitigation
  • Exercise: Validation Master Plan (VMP) Writing

Module 9: System Requirements and Design

• • Requirements Development
  • User Requirements Specification (URS)
  • Functional Requirements Specification (FRS)
  • Exercise: Interviews and URS/FRS Writing
  • System Design/Configuration Management Specification (SDS/CMS)

Module 10: IQ, OQ, PQ Test Planning and Execution

• • IQ, OQ, PQ Purpose and Contents
  • CSV Test Execution
  • Exercise: IQ, OQ, PQ Test Protocol Writing
  • CSV Test Summary Report

Module 11: Requirements Traceability Matrix (RTM)

• • RTM Purpose and Contents
  • Exercise: RTM Writing

Module 12: Test and Validation Reports

• • Validation Summary Report (VSR) Purpose and Contents
  • System Acceptance and Release Notification

Module 13: Change Management

• • Maintaining Validation Status
  • Change Control Process
  • Security and Access
  • Audit Trail Review
  • Incident Reporting
  • Periodic System Review
  • Disaster Recovery Planning
  • Business Continuity Planning

Module 14: System Retirement

• • Record Retention
  • System Retirement Challenges
  • Legacy Systems and Integration
  • Data Migration

Module 15: FDA Warning Letters

• • Regulatory Influences
  • Regulatory Trends
  • Critical Thinking
  • Current Compliance and Enforcement Trends
  • FDA Inspection Readiness
  • Exercise: Be the Consultant
  • Industry Best Practices

Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Exercises: Independent Study

The following exercises will be included in the course content and can be completed at each attendee’s discretion.

If completed before the end of the Boot Camp, the attendee may ask questions during any Q&A session. If completed after the Boot Camp, the attendee may ask questions via Compliance Meet and a response will be sent as quickly as possible.

Note that both questions and answers are provided for each exercise.

1. 1. Exercise: Exploring the Regulations using the fda.gov website
   2. Exercise: FDA Guidance for ER/ES
   3. Exercise: Validation Master Plan (VMP) Writing
   4. Exercise: Interviews and URS/FRS Writing
   5. Exercise: IQ, OQ, PQ Test Protocol Writing
   6. Exercise: RTM Writing
   7. Exercise: VSR Writing
   8. Exercise: Be the Consultant – Example of a Data Integrity Audit by FDA at a pharmaceutical manufacturer

CSV Final Exam: Completed at the discretion of the attendee. Note that both questions and answers are provided for each exercise. (100 Questions/Answers)

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

DAY 1 & 2 : 6-Hrs each day

Module 1: Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology

• • FDA Compliance and Guidance
  • Other Regulations and Guidance (EMA, EU, MHRA)
• Exercise: Exploring the Regulations using the fda.gov website

Module 2: CSV Methods and Models

• • GxP Systems
  • Computer System Validation (CSV)
  • Validation, Verification, and Qualification
  • Common SDLC Methodologies
  • GAMP 5 “V” Model

Module 3: Software and Services

• • Computer Off-the-Shelf (COTS) Software
  • Cloud Systems
  • FDA’s “Case for Quality”
  • Software as a Service (SaaS)
  • Case Study: Cloud SaaS
  • Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
  • Single Sign On (SSO)
  • Medical Devices and Software as a Medical Device (SaaMD)
  • Software Quality Assurance (SQA) Plan
  • Mobile Devices and Medical Application
  • Spreadsheet Validation

Module 4: 21 CFR Part 11, FDA’s Guidance for ER/ES

• • 21 CFR Part 11 Guidance
  • Electronic Records/Signatures (ER/ES) Requirements
  • Exercise: FDA Guidance for ER/ES
  • Vendor Audit

Module 5: Data Integrity and Governance

• • Data Life Cycle Approach
  • Data Integrity
  • Data Governance

Module 6: CSV Planning

• • Validation Strategy Document (VSD)
  • Validation Strategy Components
  • Rationale for Validation Testing
  • GAMP 5 System Categorization

Module 7: CSV Supporting Components

• • Good Documentation Practices (GDPs) Training
  • Organizational Change Management (OCM)
  • CSV Policies and Procedures

Module 8: Risk-Based CSV

• • Risk Assessment
  • Risk Mitigation
  • Exercise: Validation Master Plan (VMP) Writing

Module 9: System Requirements and Design

• • Requirements Development
  • User Requirements Specification (URS)
  • Functional Requirements Specification (FRS)
  • Exercise: Interviews and URS/FRS Writing
  • System Design/Configuration Management Specification (SDS/CMS)

Module 10: IQ, OQ, PQ Test Planning and Execution

• • IQ, OQ, PQ Purpose and Contents
  • CSV Test Execution
  • Exercise: IQ, OQ, PQ Test Protocol Writing
  • CSV Test Summary Report

Module 11: Requirements Traceability Matrix (RTM)

• • RTM Purpose and Contents
  • Exercise: RTM Writing

Module 12: Test and Validation Reports

• • Validation Summary Report (VSR) Purpose and Contents
  • System Acceptance and Release Notification

Module 13: Change Management

• • Maintaining Validation Status
  • Change Control Process
  • Security and Access
  • Audit Trail Review
  • Incident Reporting
  • Periodic System Review
  • Disaster Recovery Planning
  • Business Continuity Planning

Module 14: System Retirement

• • Record Retention
  • System Retirement Challenges
  • Legacy Systems and Integration
  • Data Migration

Module 15: FDA Warning Letters

• • Regulatory Influences
  • Regulatory Trends
  • Critical Thinking
  • Current Compliance and Enforcement Trends
  • FDA Inspection Readiness
  • Exercise: Be the Consultant
  • Industry Best Practices

Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Exercises: Independent Study

The following exercises will be included in the course content and can be completed at each attendee’s discretion.

If completed before the end of the Boot Camp, the attendee may ask questions during any Q&A session. If completed after the Boot Camp, the attendee may ask questions via Compliance Meet and a response will be sent as quickly as possible.

Note that both questions and answers are provided for each exercise.

1. 1. Exercise: Exploring the Regulations using the fda.gov website
   2. Exercise: FDA Guidance for ER/ES
   3. Exercise: Validation Master Plan (VMP) Writing
   4. Exercise: Interviews and URS/FRS Writing
   5. Exercise: IQ, OQ, PQ Test Protocol Writing
   6. Exercise: RTM Writing
   7. Exercise: VSR Writing
   8. Exercise: Be the Consultant – Example of a Data Integrity Audit by FDA at a pharmaceutical manufacturer

CSV Final Exam: Completed at the discretion of the attendee. Note that both questions and answers are provided for each exercise. (100 Questions/Answers)

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.

Everybody benefits from watching this. Even better when done as a group!

• • Quality Managers Seeking To Ensure Data Integrity And Compliance
    Gain the tools needed to maintain data accuracy in FDA-regulated environments.
  • IT Directors Aiming To Streamline Validation Processes For Critical Systems
    Learn methods to reduce system downtime and optimize operational efficiency.
  • Regulatory Affairs Professionals Needing To Stay Updated On FDA Guidelines
    Master the latest requirements, including 21 CFR Part 11, for hassle-free audits.
  • Training Managers Designing Development Paths For Teams In Regulated Industries
    Equip your team with practical CSV knowledge to enhance compliance and productivity.
  • Pharmaceutical And Biotech Professionals Facing Challenges With System Validation
    Learn best practices for validating complex software and systems in your industry.
  • Compliance Officers Looking To Strengthen Their Organization’s Validation Strategies
    Develop robust validation plans that align with FDA’s risk-based approach.
  • HR Professionals Focused On Upskilling Staff For Regulatory Compliance
    Identify key training opportunities to ensure staff are audit-ready.
  • Project Managers Handling Software Implementations In FDA-Regulated Settings
    Gain insights into validation requirements for smooth system deployment.
  • Manufacturing Managers Seeking To Minimize Risks Of System Failures
    Discover effective strategies for maintaining validated systems across their lifecycle.

Everybody benefits from watching this. Even better when done as a group!

• • Quality Managers Seeking To Ensure Data Integrity And Compliance
    Gain the tools needed to maintain data accuracy in FDA-regulated environments.
  • IT Directors Aiming To Streamline Validation Processes For Critical Systems
    Learn methods to reduce system downtime and optimize operational efficiency.
  • Regulatory Affairs Professionals Needing To Stay Updated On FDA Guidelines
    Master the latest requirements, including 21 CFR Part 11, for hassle-free audits.
  • Training Managers Designing Development Paths For Teams In Regulated Industries
    Equip your team with practical CSV knowledge to enhance compliance and productivity.
  • Pharmaceutical And Biotech Professionals Facing Challenges With System Validation
    Learn best practices for validating complex software and systems in your industry.
  • Compliance Officers Looking To Strengthen Their Organization’s Validation Strategies
    Develop robust validation plans that align with FDA’s risk-based approach.
  • HR Professionals Focused On Upskilling Staff For Regulatory Compliance
    Identify key training opportunities to ensure staff are audit-ready.
  • Project Managers Handling Software Implementations In FDA-Regulated Settings
    Gain insights into validation requirements for smooth system deployment.
  • Manufacturing Managers Seeking To Minimize Risks Of System Failures
    Discover effective strategies for maintaining validated systems across their lifecycle.