Instructor :
Carolyn Troiano

Webinar ID:
11406

Bootcamp Objective: Immerse yourself in the dynamic world of Computer System Validation (CSV) and learn how its effective application can streamline operations, enhance efficiency, and reduce the risk of system errors or failures.

Through practical case studies and engaging discussions, this bootcamp equips you with CSV expertise, ensuring smoother processes, reduced downtime, and improved operational effectiveness.

For over three decades, the FDA has enforced regulations on computer system validation in the pharmaceutical, biotechnology, medical device sectors, and other FDA-regulated industries.

These regulations mandate meticulous planning, implementation, testing, and management of systems handling data.

In 1997, the FDA introduced guidelines for Electronic Records and Electronic Signatures (ER/ES), further detailed in 21 CFR Part 11. This regulation outlines the requirements for documenting and validating ER/ES in FDA-regulated systems.

Recognizing the challenge of inspecting every computer system, the FDA now requires industries to self-assess their systems based on risk, necessitating a well-thought validation rationale and strategy focused on potential system malfunction risks.

Key Testing Scope: Testing revolves around five critical factors: system size, complexity, business importance, GAMP 5 category, and risk rating.

The FDA’s increased emphasis on data integrity in computer system validation underscores the need for compliant systems. This includes systems involved in data creation, collection, analysis, management, transfer, and reporting under FDA regulation.

In This Interactive Bootcamp:

• • Explore best practices and strategies for assessing computer systems in FDA-regulated environments.
  • Understand the impact of system failures on data integrity, product quality, and consumer safety.
  • Examine the System Development Life Cycle (SDLC) for validation, with a focus on risk assessment.
  • Delve into 21 CFR Part 11, highlighting the importance of managing electronic records and signatures.
  • Learn about essential policies, procedures, and documentation for compliance.
  • Prepare for an FDA inspection and understand the criticality of auditing computer system hardware, software, and service vendors.
  • Master industry standards, with a strong emphasis on data integrity and risk evaluation, to excel in your GxP-related roles.

Enroll Now!

Bootcamp Objective: Immerse yourself in the dynamic world of Computer System Validation (CSV) and learn how its effective application can streamline operations, enhance efficiency, and reduce the risk of system errors or failures.

Through practical case studies and engaging discussions, this bootcamp equips you with CSV expertise, ensuring smoother processes, reduced downtime, and improved operational effectiveness.

For over three decades, the FDA has enforced regulations on computer system validation in the pharmaceutical, biotechnology, medical device sectors, and other FDA-regulated industries.

These regulations mandate meticulous planning, implementation, testing, and management of systems handling data.

In 1997, the FDA introduced guidelines for Electronic Records and Electronic Signatures (ER/ES), further detailed in 21 CFR Part 11. This regulation outlines the requirements for documenting and validating ER/ES in FDA-regulated systems.

Recognizing the challenge of inspecting every computer system, the FDA now requires industries to self-assess their systems based on risk, necessitating a well-thought validation rationale and strategy focused on potential system malfunction risks.

Key Testing Scope: Testing revolves around five critical factors: system size, complexity, business importance, GAMP 5 category, and risk rating.

The FDA’s increased emphasis on data integrity in computer system validation underscores the need for compliant systems. This includes systems involved in data creation, collection, analysis, management, transfer, and reporting under FDA regulation.

In This Interactive Bootcamp:

• • Explore best practices and strategies for assessing computer systems in FDA-regulated environments.
  • Understand the impact of system failures on data integrity, product quality, and consumer safety.
  • Examine the System Development Life Cycle (SDLC) for validation, with a focus on risk assessment.
  • Delve into 21 CFR Part 11, highlighting the importance of managing electronic records and signatures.
  • Learn about essential policies, procedures, and documentation for compliance.
  • Prepare for an FDA inspection and understand the criticality of auditing computer system hardware, software, and service vendors.
  • Master industry standards, with a strong emphasis on data integrity and risk evaluation, to excel in your GxP-related roles.

Enroll Now!

Drawing from real-world experience, we’ve crafted a computer system validation (CSV) course that aligns with FDA, ICH, and Eudralex standards for risk-based validation, equipping you to integrate these practices seamlessly within your organization.

Our class employs standard operating procedures and validation templates already validated by other enterprises.

We prioritize your understanding and practical application of CSV techniques, aiming for efficient, effective, and inspection-ready validation drives.

Join our Boot Camp for a comprehensive dive into FDA-regulated computer system validation. We’ll introduce diverse approaches, techniques, and tools to enhance your validation activity’s efficiency and efficacy!

During the course, you’ll:

• • Recognize “GxP” Systems.
  • Delve into the CSV approach anchored in FDA stipulations.
  • Explore the System Development Life Cycle (SDLC) method of validation.
  • Adhere to prominent FDA and international CSV regulations and guidance, like 21 CFR Part 11 and Annex 11.
  • Unpack the content and objectives of various validation deliverables, such as
  • Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), and more.
  • Grasp risk-based validation techniques and craft compliant validation methods.
  • Determine apt validation approaches for diverse applications like Cloud/SaaS, spreadsheets, and custom systems.
  • Familiarize with best practices and inspector anticipations for CSV and software quality assurance (SQA).
  • Master documentation best practices for CSV endeavors, spanning requirements to operational maintenance procedures.
  • Sustain a validated system throughout its lifespan.
  • Safeguard the integrity of GxP-supporting data.
  • Emphasize “GxP” documentation aligning with FDA guidelines.
  • Recognize the requisite policies and protocols for system validation and continuous maintenance.
  • Dissect the essential facets of 21 CFR Part 11 compliance concerning electronic records and signatures.
  • Keep abreast of regulatory influences shaping FDA’s current perspectives.
  • Conduct comprehensive risk evaluations on computer systems, laying groundwork for a robust validation rationale.
  • Consider system dimensions, intricacy, business significance, GAMP 5 category, and potential risk of failure in shaping your validation strategy.
  • Prepare adeptly for any FDA computer system audits.
  • Recognize vendor audit’s importance to ensure quality deliverables.
  • Finally, integrate industry benchmarks to refine your validation and compliance stance, centered on risk evaluation, and sustain data integrity through the data lifecycle.
  • Q&A Session

Our boot camp aims to bestow you with the acumen to demystify CSV complexities, positioning your organization at the pinnacle of compliance, innovation, and quality.

Join Now!

Drawing from real-world experience, we’ve crafted a computer system validation (CSV) course that aligns with FDA, ICH, and Eudralex standards for risk-based validation, equipping you to integrate these practices seamlessly within your organization.

Our class employs standard operating procedures and validation templates already validated by other enterprises.

We prioritize your understanding and practical application of CSV techniques, aiming for efficient, effective, and inspection-ready validation drives.

Join our Boot Camp for a comprehensive dive into FDA-regulated computer system validation. We’ll introduce diverse approaches, techniques, and tools to enhance your validation activity’s efficiency and efficacy!

During the course, you’ll:

• • Recognize “GxP” Systems.
  • Delve into the CSV approach anchored in FDA stipulations.
  • Explore the System Development Life Cycle (SDLC) method of validation.
  • Adhere to prominent FDA and international CSV regulations and guidance, like 21 CFR Part 11 and Annex 11.
  • Unpack the content and objectives of various validation deliverables, such as
  • Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), and more.
  • Grasp risk-based validation techniques and craft compliant validation methods.
  • Determine apt validation approaches for diverse applications like Cloud/SaaS, spreadsheets, and custom systems.
  • Familiarize with best practices and inspector anticipations for CSV and software quality assurance (SQA).
  • Master documentation best practices for CSV endeavors, spanning requirements to operational maintenance procedures.
  • Sustain a validated system throughout its lifespan.
  • Safeguard the integrity of GxP-supporting data.
  • Emphasize “GxP” documentation aligning with FDA guidelines.
  • Recognize the requisite policies and protocols for system validation and continuous maintenance.
  • Dissect the essential facets of 21 CFR Part 11 compliance concerning electronic records and signatures.
  • Keep abreast of regulatory influences shaping FDA’s current perspectives.
  • Conduct comprehensive risk evaluations on computer systems, laying groundwork for a robust validation rationale.
  • Consider system dimensions, intricacy, business significance, GAMP 5 category, and potential risk of failure in shaping your validation strategy.
  • Prepare adeptly for any FDA computer system audits.
  • Recognize vendor audit’s importance to ensure quality deliverables.
  • Finally, integrate industry benchmarks to refine your validation and compliance stance, centered on risk evaluation, and sustain data integrity through the data lifecycle.
  • Q&A Session

Our boot camp aims to bestow you with the acumen to demystify CSV complexities, positioning your organization at the pinnacle of compliance, innovation, and quality.

Join Now!

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: 4-Hrs

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

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

DAY 2: 4-Hrs

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

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

DAY 3: 4-Hrs

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: 4-Hrs

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

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

DAY 2: 4-Hrs

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

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

DAY 3: 4-Hrs

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 Assurance Managers Seeking Reliable CSV Practices To Avoid Compliance Issues
  • Regulatory Affairs Specialists Aiming To Ensure All Systems Meet FDA Standards
  • IT Managers Focused On Integrating GxP-Compliant Systems Across The Organization
  • Operations Leaders Who Want To Minimize Downtime Through Effective Validation
  • Data Integrity Officers Striving To Safeguard Data In FDA-Regulated Environments
  • HR Professionals Tasked With Building CSV Training Programs For Key Teams
  • Training Managers Designing Learning Paths That Enhance Validation Competency
  • Compliance Officers Addressing Gaps In Electronic Records And Signature Compliance
  • Pharmaceutical And Medical Device Professionals Ensuring Products Meet Regulatory Standards

Everybody Benefits from Watching This. Even Better When Done as a Group!

• • Quality Assurance Managers Seeking Reliable CSV Practices To Avoid Compliance Issues
  • Regulatory Affairs Specialists Aiming To Ensure All Systems Meet FDA Standards
  • IT Managers Focused On Integrating GxP-Compliant Systems Across The Organization
  • Operations Leaders Who Want To Minimize Downtime Through Effective Validation
  • Data Integrity Officers Striving To Safeguard Data In FDA-Regulated Environments
  • HR Professionals Tasked With Building CSV Training Programs For Key Teams
  • Training Managers Designing Learning Paths That Enhance Validation Competency
  • Compliance Officers Addressing Gaps In Electronic Records And Signature Compliance
  • Pharmaceutical And Medical Device Professionals Ensuring Products Meet Regulatory Standards