Instructor :
Carolyn Troiano

Webinar ID:
11893

FDA-regulated industries have adhered to computer system validation for over 30 years, covering systems in manufacturing, testing, and distribution.

These regulations ensure thorough planning, implementation, integration, testing, and management of computer systems that handle crucial data.

Key Highlights:

• • Introduction to Electronic Records and Signatures (ER/ES) via 21 CFR Part 11, detailing the requirements for validation in FDA-regulated environments.
  • Evolution of industry responsibility for risk-based validation of computer systems, including:
    • • System size and complexity
      • Business criticality
      • GAMP®5 category
      • Risk rating

• • Overview of the traditional Computer System Validation (CSV) approach versus Computer Software Assurance (CSA), emphasizing FDA’s flexibility in compliance methods.
  • Insights into how GAMP®5 Second Edition aligns with CSA for a streamlined compliance process.

This webinar will delve into FDA’s heightened focus on data integrity during computer system validation, covering systems involved in data creation, collection, analysis, management, and reporting.

Key areas include:

• • Best industry practices in GAMP®5 Second Edition and their impact on validation processes.
  • FDA’s recent draft guidance on CSA and its implications for validation approaches.
  • Strategic evaluation of computer systems for data integrity, product quality, and consumer safety, using the System Development Life Cycle (SDLC) approach based on risk assessment.
  • Understanding and managing 21 CFR Part 11 for electronic records and signatures.
  • Developing essential policies, procedures, and preparing for FDA inspections.
  • Vendor auditing for hardware, software, and services to ensure compliance.
  • Industry best practices with a focus on data integrity and risk assessment using GAMP®5 and CSA.

By the end of this webinar, attendees will gain a comprehensive understanding of how to effectively leverage GAMP®5 Second Edition and CSA to achieve compliance in FDA-regulated environments.

Enroll Now!

FDA-regulated industries have adhered to computer system validation for over 30 years, covering systems in manufacturing, testing, and distribution.

These regulations ensure thorough planning, implementation, integration, testing, and management of computer systems that handle crucial data.

Key Highlights:

• • Introduction to Electronic Records and Signatures (ER/ES) via 21 CFR Part 11, detailing the requirements for validation in FDA-regulated environments.
  • Evolution of industry responsibility for risk-based validation of computer systems, including:
    • • System size and complexity
      • Business criticality
      • GAMP®5 category
      • Risk rating

• • Overview of the traditional Computer System Validation (CSV) approach versus Computer Software Assurance (CSA), emphasizing FDA’s flexibility in compliance methods.
  • Insights into how GAMP®5 Second Edition aligns with CSA for a streamlined compliance process.

This webinar will delve into FDA’s heightened focus on data integrity during computer system validation, covering systems involved in data creation, collection, analysis, management, and reporting.

Key areas include:

• • Best industry practices in GAMP®5 Second Edition and their impact on validation processes.
  • FDA’s recent draft guidance on CSA and its implications for validation approaches.
  • Strategic evaluation of computer systems for data integrity, product quality, and consumer safety, using the System Development Life Cycle (SDLC) approach based on risk assessment.
  • Understanding and managing 21 CFR Part 11 for electronic records and signatures.
  • Developing essential policies, procedures, and preparing for FDA inspections.
  • Vendor auditing for hardware, software, and services to ensure compliance.
  • Industry best practices with a focus on data integrity and risk assessment using GAMP®5 and CSA.

By the end of this webinar, attendees will gain a comprehensive understanding of how to effectively leverage GAMP®5 Second Edition and CSA to achieve compliance in FDA-regulated environments.

Enroll Now!

This 90-minute webinar is essential for professionals in FDA-regulated industries—pharmaceuticals, medical devices, biologics, and tobacco products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.)—who are involved in the planning, execution, or support of computer system validation (CSV).

With new FDA guidelines and evolving industry standards, now is the time to update your skills and lead your organization to compliance excellence.

Key Reasons to Attend:

• • Stay Current with GAMP®5 and CSA
    • • Learn how to adapt your current validation practices to align with GAMP®5 Second Edition (July 2022) and the FDA’s CSA Draft Guidance (September 2022). Stay ahead by adopting cutting-edge compliance standards.

• • Gain Insights into New Guidelines
    • • Discover how these latest guidelines impact validation processes, especially with innovative technologies that are transforming the landscape. Equip yourself with the insights to navigate this shift effectively.

• • Modernize Your Approach to Validation
    • • Leave outdated methods behind and learn strategies to leverage modern technological advancements in validation. Enhance both compliance and operational efficiency for your organization.

• • Achieve Competitive Advantage through Compliance
    • • Staying updated with GAMP®5 and CSA not only ensures compliance but also opens the door to innovative tools that can propel business success. Position your organization as a forward-thinking leader in the industry.

• • Accelerate Market Readiness of Products
    • • Mastering these new approaches helps bring advanced products to market faster, keeping your company compliant, competitive, and agile in a rapidly changing industry.

By attending, you’ll gain actionable knowledge to rethink validation practices and harness the latest technologies to achieve compliance.

Propel your career and organization toward greater success by mastering these essential FDA compliance strategies.

Join Now and be at the forefront of compliance innovation!

This 90-minute webinar is essential for professionals in FDA-regulated industries—pharmaceuticals, medical devices, biologics, and tobacco products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.)—who are involved in the planning, execution, or support of computer system validation (CSV).

With new FDA guidelines and evolving industry standards, now is the time to update your skills and lead your organization to compliance excellence.

Key Reasons to Attend:

• • Stay Current with GAMP®5 and CSA
    • • Learn how to adapt your current validation practices to align with GAMP®5 Second Edition (July 2022) and the FDA’s CSA Draft Guidance (September 2022). Stay ahead by adopting cutting-edge compliance standards.

• • Gain Insights into New Guidelines
    • • Discover how these latest guidelines impact validation processes, especially with innovative technologies that are transforming the landscape. Equip yourself with the insights to navigate this shift effectively.

• • Modernize Your Approach to Validation
    • • Leave outdated methods behind and learn strategies to leverage modern technological advancements in validation. Enhance both compliance and operational efficiency for your organization.

• • Achieve Competitive Advantage through Compliance
    • • Staying updated with GAMP®5 and CSA not only ensures compliance but also opens the door to innovative tools that can propel business success. Position your organization as a forward-thinking leader in the industry.

• • Accelerate Market Readiness of Products
    • • Mastering these new approaches helps bring advanced products to market faster, keeping your company compliant, competitive, and agile in a rapidly changing industry.

By attending, you’ll gain actionable knowledge to rethink validation practices and harness the latest technologies to achieve compliance.

Propel your career and organization toward greater success by mastering these essential FDA compliance strategies.

Join Now and be at the forefront of compliance innovation!

1. Introduction to GxP Systems

• • Identifying systems subject to Good Practice (GxP) compliance
  • Understanding the regulatory implications of GxP categorization

2. GAMP®5 Second Edition Overview

• • Key updates and their impact on validation practices
  • Aligning GAMP®5 with FDA’s CSA initiative for smarter compliance

3. Computer System Validation (CSV) vs. Computer Software Assurance (CSA)

• • Traditional CSV: principles, limitations, and compliance focus
  • CSA: a modern, risk-based alternative encouraged by FDA
  • Comparative insights to guide transition and implementation

4. System Development Life Cycle (SDLC) in Validation

• • Applying SDLC principles for regulated systems
  • Ensuring validation through all phases—from planning to retirement

5. Effective Documentation for Validation

• • Best practices for documenting requirements, design, testing, and maintenance
  • Strategies to support traceability and audit readiness

6. Maintaining a Validated State

• • Change control, periodic reviews, and continuous monitoring
  • Handling system updates without compromising compliance

7. Assuring Data Integrity

• • Ensuring reliable data across creation, collection, analysis, and reporting
  • Common pitfalls and how to prevent them

8. 21 CFR Part 11 Compliance

• • Key requirements for electronic records and electronic signatures
  • Strategies to achieve and maintain compliance

9. Policies, Procedures, and Documentation Controls

• • Core validation policies and SOPs needed for ongoing compliance
  • Aligning internal documentation with regulatory expectations

10. Regulatory Drivers and FDA’s Current Thinking

• • Understanding recent guidance documents and industry trends
  • Practical implications for validation planning and execution

11. Risk-Based Validation Planning

• • Conducting system risk assessments
  • Evaluating system size, complexity, criticality, and failure impact
  • Determining appropriate validation level and rigor

12. Preparing for FDA Inspections and Audits

• • What inspectors look for in GxP systems
  • Tips for proactive audit readiness

13. Vendor Oversight and Auditing

• • Conducting vendor audits for software, hardware, and service providers
  • Ensuring supplier compliance and accountability

14. Industry Best Practices

• • Leveraging GAMP®5 and CSA to enhance validation efficiency
  • Promoting compliance and data integrity throughout the system life cycle

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

1. Introduction to GxP Systems

• • Identifying systems subject to Good Practice (GxP) compliance
  • Understanding the regulatory implications of GxP categorization

2. GAMP®5 Second Edition Overview

• • Key updates and their impact on validation practices
  • Aligning GAMP®5 with FDA’s CSA initiative for smarter compliance

3. Computer System Validation (CSV) vs. Computer Software Assurance (CSA)

• • Traditional CSV: principles, limitations, and compliance focus
  • CSA: a modern, risk-based alternative encouraged by FDA
  • Comparative insights to guide transition and implementation

4. System Development Life Cycle (SDLC) in Validation

• • Applying SDLC principles for regulated systems
  • Ensuring validation through all phases—from planning to retirement

5. Effective Documentation for Validation

• • Best practices for documenting requirements, design, testing, and maintenance
  • Strategies to support traceability and audit readiness

6. Maintaining a Validated State

• • Change control, periodic reviews, and continuous monitoring
  • Handling system updates without compromising compliance

7. Assuring Data Integrity

• • Ensuring reliable data across creation, collection, analysis, and reporting
  • Common pitfalls and how to prevent them

8. 21 CFR Part 11 Compliance

• • Key requirements for electronic records and electronic signatures
  • Strategies to achieve and maintain compliance

9. Policies, Procedures, and Documentation Controls

• • Core validation policies and SOPs needed for ongoing compliance
  • Aligning internal documentation with regulatory expectations

10. Regulatory Drivers and FDA’s Current Thinking

• • Understanding recent guidance documents and industry trends
  • Practical implications for validation planning and execution

11. Risk-Based Validation Planning

• • Conducting system risk assessments
  • Evaluating system size, complexity, criticality, and failure impact
  • Determining appropriate validation level and rigor

12. Preparing for FDA Inspections and Audits

• • What inspectors look for in GxP systems
  • Tips for proactive audit readiness

13. Vendor Oversight and Auditing

• • Conducting vendor audits for software, hardware, and service providers
  • Ensuring supplier compliance and accountability

14. Industry Best Practices

• • Leveraging GAMP®5 and CSA to enhance validation efficiency
  • Promoting compliance and data integrity throughout the system life cycle

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

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

• • Quality Leaders Aiming to Enhance Compliance
  • Validation Managers Seeking Best Practices
  • IT Professionals Ensuring System Integrity
  • Regulatory Affairs Experts Focused on FDA Compliance
  • Project Managers Overseeing Validation Projects
  • Training Managers Building Competent, Compliance-Savvy Teams
  • HR Professionals Developing Compliance-Oriented Learning Plans
  • Operations Managers Focused on Efficient Compliance
  • Product Managers Bringing Safe, Compliant Products to Market Faster

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

• • Quality Leaders Aiming to Enhance Compliance
  • Validation Managers Seeking Best Practices
  • IT Professionals Ensuring System Integrity
  • Regulatory Affairs Experts Focused on FDA Compliance
  • Project Managers Overseeing Validation Projects
  • Training Managers Building Competent, Compliance-Savvy Teams
  • HR Professionals Developing Compliance-Oriented Learning Plans
  • Operations Managers Focused on Efficient Compliance
  • Product Managers Bringing Safe, Compliant Products to Market Faster