Instructor :
Carolyn Troiano

Webinar ID:
9255

Bootcamp Objective: Dive into the world of Computer System Validation (CSV) and discover how its successful implementation can streamline operations, enhance efficiency, and mitigate the risk of system errors or failures. Using real-world case studies and interactive discussions, this bootcamp will mold you into a CSV expert, paving the way for smoother processes, minimized downtime, and bolstered operational prowess.

For over three decades, the FDA has regulated computer system validation. This pertains to systems employed in the manufacturing, testing, and distribution across pharmaceutical, biotechnology, medical device sectors, and other FDA-regulated industries.

The FDA mandates comprehensive planning, implementation, integration, testing, and management of systems that capture, analyze, and/or relay data.

In 1997, the FDA initiated guidelines for Electronic Records and Electronic Signatures (ER/ES), which were further detailed in 21 CFR Part 11. This code delineates the fundamental requirements for documenting and validating ER/ES capability in FDA-regulated systems.

In the early 2000s, a realization dawned upon the FDA: inspecting every computer system at each regulated firm was implausible. Consequently, the responsibility shifted to industries to evaluate all their regulated systems based on risk. Companies now had to craft a validation rationale and strategy, rooted in potential system malfunction risks.

Determining the scope of testing required for data integrity and product safety revolves around five pivotal components: system size, complexity, business importance, GAMP 5 category, and risk rating.

The FDA’s amplified focus on data integrity concerning computer system validation highlights the paramount importance of compliant systems in regulated sectors. This encompasses all systems interacting with products, meaning those involved in data creation, collection, analysis, management, transfer, and reporting under FDA regulation.

From databases to documents, spreadsheets, presentations, and multimedia files, maintaining data integrity throughout its lifecycle is crucial.

In This Interactive Bootcamp:

• Delve into best practices and a strategic framework for assessing computer systems in FDA-regulated operations. Gauge the ramifications of potential system failures on data integrity, product quality, and consumer safety.
• Traverse the System Development Life Cycle (SDLC) for validation, anchored in risk assessment. Dive deep into 21 CFR Part 11, underscoring the significance of handling electronic records and signatures aptly.
• Navigate essential policies, procedures, and supporting documentation vital for compliance.
• Prepare for an FDA inspection and grasp the essence of computer system hardware, software, and services vendor audits.
• Absorb industry gold standards, emphasizing data integrity and risk evaluation, equipping you for all your GxP endeavors.

Enroll Now!

Bootcamp Objective: Dive into the world of Computer System Validation (CSV) and discover how its successful implementation can streamline operations, enhance efficiency, and mitigate the risk of system errors or failures. Using real-world case studies and interactive discussions, this bootcamp will mold you into a CSV expert, paving the way for smoother processes, minimized downtime, and bolstered operational prowess.

For over three decades, the FDA has regulated computer system validation. This pertains to systems employed in the manufacturing, testing, and distribution across pharmaceutical, biotechnology, medical device sectors, and other FDA-regulated industries.

The FDA mandates comprehensive planning, implementation, integration, testing, and management of systems that capture, analyze, and/or relay data.

In 1997, the FDA initiated guidelines for Electronic Records and Electronic Signatures (ER/ES), which were further detailed in 21 CFR Part 11. This code delineates the fundamental requirements for documenting and validating ER/ES capability in FDA-regulated systems.

In the early 2000s, a realization dawned upon the FDA: inspecting every computer system at each regulated firm was implausible. Consequently, the responsibility shifted to industries to evaluate all their regulated systems based on risk. Companies now had to craft a validation rationale and strategy, rooted in potential system malfunction risks.

Determining the scope of testing required for data integrity and product safety revolves around five pivotal components: system size, complexity, business importance, GAMP 5 category, and risk rating.

The FDA’s amplified focus on data integrity concerning computer system validation highlights the paramount importance of compliant systems in regulated sectors. This encompasses all systems interacting with products, meaning those involved in data creation, collection, analysis, management, transfer, and reporting under FDA regulation.

From databases to documents, spreadsheets, presentations, and multimedia files, maintaining data integrity throughout its lifecycle is crucial.

In This Interactive Bootcamp:

• Delve into best practices and a strategic framework for assessing computer systems in FDA-regulated operations. Gauge the ramifications of potential system failures on data integrity, product quality, and consumer safety.
• Traverse the System Development Life Cycle (SDLC) for validation, anchored in risk assessment. Dive deep into 21 CFR Part 11, underscoring the significance of handling electronic records and signatures aptly.
• Navigate essential policies, procedures, and supporting documentation vital for compliance.
• Prepare for an FDA inspection and grasp the essence of computer system hardware, software, and services vendor audits.
• Absorb industry gold standards, emphasizing data integrity and risk evaluation, equipping you for all your GxP endeavors.

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!

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

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

Maximize The Learning Experience in A Group Setting!

• Information Technology (IT) Analysts
• IT Developers, IT Support Staff
• QC/QA Managers and Analysts
• Manufacturing Personnel
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Supply Chain Personnel
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Software Development Companies and Personnel (develop software for the medical device industry)
• Consultants in the Life Sciences and Tobacco Industries

Maximize The Learning Experience in A Group Setting!

• Information Technology (IT) Analysts
• IT Developers, IT Support Staff
• QC/QA Managers and Analysts
• Manufacturing Personnel
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Supply Chain Personnel
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Software Development Companies and Personnel (develop software for the medical device industry)
• Consultants in the Life Sciences and Tobacco Industries