Mastering Compliance for FDA-Regulated Systems: Leveraging CSA and GAMP®5 Second Edition

Struggling to Balance Innovation with Compliance in FDA-Regulated Systems?

Instructor :
Carolyn Troiano

Webinar ID:
11893

Date: NOV 21, 2024 (THU)

Start Time: 10 AM PT - 11:30 AM PT

Duration: 90 Mins.

What will you learn

    • Identify “GxP” Systems And Understand Their Compliance Requirements.
    • Explore GAMP®5 (Second Edition) Best Practices For Validation.
    • Learn The Computer System Validation (CSV) Approach Per FDA.
    • Implement System Development Life Cycle (SDLC) In Validation.
    • Document Validation Efforts: Requirements, Design, Testing, And Maintenance.
    • Ensure Data Integrity And Compliance With 21 CFR Part 11.
    • Conduct Risk Assessments And Develop Comprehensive Validation Rationale.
    • Prepare For FDA Inspections And ….
    • Identify “GxP” Systems And Understand Their Compliance Requirements.
    • Explore GAMP®5 (Second Edition) Best Practices For Validation.
    • Learn The Computer System Validation (CSV) Approach Per FDA.
    • Implement System Development Life Cycle (SDLC) In Validation.
    • Document Validation Efforts: Requirements, Design, Testing, And Maintenance.
    • Ensure Data Integrity And Compliance With 21 CFR Part 11.
    • Conduct Risk Assessments And Develop Comprehensive Validation Rationale.
    • Prepare For FDA Inspections And Perform Effective Vendor Audits.
    • Apply Industry Best Practices To Optimize Validation And Compliance.

Course Description

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!

Why you should attend

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

What You Will Learn:

    • How to adapt current validation methods to align with GAMP®5, Second Edition (published in July 2022) and Computer Software Assurance (CSA), which is the subject of FDA’s Draft Guidance issued in September 2022.
    • Insights into how these new guidelines will reshape validation practices, especially for systems based on innovative technologies.
    • Strategies for leveraging modern technological advancements in validation, moving beyond outdated methods to enhance compliance and operational efficiency.

Why This Matters:

    • Staying updated with GAMP®5 and CSA enables companies to not only meet FDA compliance but also to embrace innovative tools that drive business success.
    • Learning to use these new approaches helps in bringing more advanced products to market, ensuring that your company remains competitive and compliant in a rapidly evolving industry landscape.

By attending, you’ll gain the knowledge to rethink validation practices, harnessing the power of new technologies to achieve compliance and propel your organization toward greater success.

Join Now!

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

What You Will Learn:

    • How to adapt current validation methods to align with GAMP®5, Second Edition (published in July 2022) and Computer Software Assurance (CSA), which is the subject of FDA’s Draft Guidance issued in September 2022.
    • Insights into how these new guidelines will reshape validation practices, especially for systems based on innovative technologies.
    • Strategies for leveraging modern technological advancements in validation, moving beyond outdated methods to enhance compliance and operational efficiency.

Why This Matters:

    • Staying updated with GAMP®5 and CSA enables companies to not only meet FDA compliance but also to embrace innovative tools that drive business success.
    • Learning to use these new approaches helps in bringing more advanced products to market, ensuring that your company remains competitive and compliant in a rapidly evolving industry landscape.

By attending, you’ll gain the knowledge to rethink validation practices, harnessing the power of new technologies to achieve compliance and propel your organization toward greater success.

Join Now!

Areas Covered

  • Introduction to “GxP” Systems: Learn how to identify systems that require Good Practice (GxP) compliance.
  • GAMP®5 (Second Edition) Overview: Understand the latest best practices from GAMP®5 and how they impact validation work.
  • Computer System Validation (CSV) Approach: Discuss the CSV approach based on FDA requirements and guidelines.
  • System Development Life Cycle (SDLC) in Validation: Learn about the SDLC approach and how it applies to validation processes.
  • Documenting Validation Efforts: Discover best practices for documenting computer system validation, including requirements, design, development, testing, and operational maintenance procedures.
  • Maintaining a Validated System: Understand how to maintain a system in a validated state throughout its entire life cycle.
  • Assuring Data Integrity: Learn how to ensure the integrity of data that supports GxP work.
  • “GxP” Documentation Compliance: Discuss the importance of documentation that complies with FDA requirements.
  • Policies and Procedures for Validation: Learn about the necessary policies and procedures to support validation processes and ongoing system maintenance.
  • 21 CFR Part 11 Compliance: Understand the key components for compliance with electronic records and signatures.
  • Regulatory Influences and FDA’s Current Thinking: Know the regulatory factors that shape FDA’s approach to computer system validation.
  • Conducting Risk Assessments: Learn how to conduct a risk assessment on computer systems to develop a validation rationale.
  • Assessing System Characteristics: Understand the need to evaluate system size, complexity, business criticality, GAMP®5 category, and risk of failure for comprehensive validation.
  • Preparing for FDA Inspections and Audits: Learn how to best prepare for an FDA inspection or audit of a GxP computer system.
  • Vendor Audits for Oversight: Understand the importance of performing thorough vendor audits to ensure oversight of their products and services.
  • Industry Best Practices for Validation and Compliance: Learn best practices based on risk assessment to optimize validation and ensure data integrity throughout the data life cycle.

BONUS:

    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.
  • Introduction to “GxP” Systems: Learn how to identify systems that require Good Practice (GxP) compliance.
  • GAMP®5 (Second Edition) Overview: Understand the latest best practices from GAMP®5 and how they impact validation work.
  • Computer System Validation (CSV) Approach: Discuss the CSV approach based on FDA requirements and guidelines.
  • System Development Life Cycle (SDLC) in Validation: Learn about the SDLC approach and how it applies to validation processes.
  • Documenting Validation Efforts: Discover best practices for documenting computer system validation, including requirements, design, development, testing, and operational maintenance procedures.
  • Maintaining a Validated System: Understand how to maintain a system in a validated state throughout its entire life cycle.
  • Assuring Data Integrity: Learn how to ensure the integrity of data that supports GxP work.
  • “GxP” Documentation Compliance: Discuss the importance of documentation that complies with FDA requirements.
  • Policies and Procedures for Validation: Learn about the necessary policies and procedures to support validation processes and ongoing system maintenance.
  • 21 CFR Part 11 Compliance: Understand the key components for compliance with electronic records and signatures.
  • Regulatory Influences and FDA’s Current Thinking: Know the regulatory factors that shape FDA’s approach to computer system validation.
  • Conducting Risk Assessments: Learn how to conduct a risk assessment on computer systems to develop a validation rationale.
  • Assessing System Characteristics: Understand the need to evaluate system size, complexity, business criticality, GAMP®5 category, and risk of failure for comprehensive validation.
  • Preparing for FDA Inspections and Audits: Learn how to best prepare for an FDA inspection or audit of a GxP computer system.
  • Vendor Audits for Oversight: Understand the importance of performing thorough vendor audits to ensure oversight of their products and services.
  • Industry Best Practices for Validation and Compliance: Learn best practices based on risk assessment to optimize validation and ensure data integrity throughout the data life cycle.

BONUS:

    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.

Who is this course for

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

    • Quality Assurance Managers
    • Validation Specialists
    • Regulatory Affairs Managers
    • Compliance Officers
    • IT Compliance Analysts
    • Clinical Data Managers
    • Pharmaceutical Engineers
    • Computer System Validation (CSV) Analysts
    • Laboratory Managers

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

    • Quality Assurance Managers
    • Validation Specialists
    • Regulatory Affairs Managers
    • Compliance Officers
    • IT Compliance Analysts
    • Clinical Data Managers
    • Pharmaceutical Engineers
    • Computer System Validation (CSV) Analysts
    • Laboratory Managers

Instructor Profile

Carolyn (McKillop) Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and ...

Carolyn (McKillop) Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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