Instructor :
Carolyn Troiano

Webinar ID:
13552

In today’s regulated environment, IT infrastructure qualification and compliance are critical to ensuring data integrity, product quality, and patient safety.

This training provides a risk-based approach to evaluating and validating computer systems used in FDA-regulated activities, equipping professionals with the knowledge and tools to maintain compliance with regulatory requirements.

Through this course, participants will gain a structured understanding of System Development Life Cycle (SDLC) validation, guided by risk assessments. The training also covers 21 CFR Part 11 compliance, emphasizing the proper management of electronic records and signatures to ensure regulatory alignment.

Key topics include:

• • Risk-Based Validation & Qualification
    • • Learn to assess and mitigate risks associated with IT infrastructure, including cloud-based servers and Software-as-a-Service (SaaS) solutions.

• • Installation Qualification (IQ) & Auditing
    • • Understand how to audit and validate third-party vendors supporting regulated systems.

• • Policies, Procedures & Documentation
    • • Explore essential compliance documentation and practices to ensure regulatory readiness.

• • FDA Inspection Preparation
    • • Gain insights into best practices for handling FDA audits and maintaining compliance in IT infrastructure.

• • Industry Best Practices & Data Integrity
    • • Learn how to apply industry-proven methodologies to strengthen data integrity across all GxP-regulated work.

This course provides practical insights and regulatory guidance to help professionals navigate FDA expectations and implement a robust compliance framework for IT infrastructure.

By the end of this training, participants will be equipped with the knowledge to confidently manage IT system qualification, compliance, and control within their organizations.

Enroll Now!

In today’s regulated environment, IT infrastructure qualification and compliance are critical to ensuring data integrity, product quality, and patient safety.

This training provides a risk-based approach to evaluating and validating computer systems used in FDA-regulated activities, equipping professionals with the knowledge and tools to maintain compliance with regulatory requirements.

Through this course, participants will gain a structured understanding of System Development Life Cycle (SDLC) validation, guided by risk assessments. The training also covers 21 CFR Part 11 compliance, emphasizing the proper management of electronic records and signatures to ensure regulatory alignment.

Key topics include:

• • Risk-Based Validation & Qualification
    • • Learn to assess and mitigate risks associated with IT infrastructure, including cloud-based servers and Software-as-a-Service (SaaS) solutions.

• • Installation Qualification (IQ) & Auditing
    • • Understand how to audit and validate third-party vendors supporting regulated systems.

• • Policies, Procedures & Documentation
    • • Explore essential compliance documentation and practices to ensure regulatory readiness.

• • FDA Inspection Preparation
    • • Gain insights into best practices for handling FDA audits and maintaining compliance in IT infrastructure.

• • Industry Best Practices & Data Integrity
    • • Learn how to apply industry-proven methodologies to strengthen data integrity across all GxP-regulated work.

This course provides practical insights and regulatory guidance to help professionals navigate FDA expectations and implement a robust compliance framework for IT infrastructure.

By the end of this training, participants will be equipped with the knowledge to confidently manage IT system qualification, compliance, and control within their organizations.

Enroll Now!

Ensuring IT infrastructure compliance in a regulated environment is not just a best practice—it’s a necessity.

Without a properly qualified and validated foundation, even the most advanced systems can fail to meet FDA expectations, leading to compliance risks, data integrity issues, and operational inefficiencies.

This training provides practical solutions for managing on-premise infrastructure, cloud-based services, and Software-as-a-Service (SaaS) platforms.

Participants will gain clear guidance on:

• • Identifying Compliance Risks
    • • Learn what to watch for in security, access control, incident reporting, and change management.

• • Simplifying Infrastructure Qualification
    • • Discover efficient, risk-based approaches to validating different hardware and software types.

• • Leveraging Technology & Vendor Support
    • • Move beyond outdated methods and adopt strategies that reduce effort while maintaining compliance.

• • Optimizing IT Compliance Processes
    • • Gain insights into ensuring quality, security, and efficiency without unnecessary complexity.

If you’re responsible for IT system qualification, compliance, or validation, this course will equip you with the latest industry best practices to streamline your approach while minimizing risk and maintaining regulatory alignment.

Join Now!

Ensuring IT infrastructure compliance in a regulated environment is not just a best practice—it’s a necessity.

Without a properly qualified and validated foundation, even the most advanced systems can fail to meet FDA expectations, leading to compliance risks, data integrity issues, and operational inefficiencies.

This training provides practical solutions for managing on-premise infrastructure, cloud-based services, and Software-as-a-Service (SaaS) platforms.

Participants will gain clear guidance on:

• • Identifying Compliance Risks
    • • Learn what to watch for in security, access control, incident reporting, and change management.

• • Simplifying Infrastructure Qualification
    • • Discover efficient, risk-based approaches to validating different hardware and software types.

• • Leveraging Technology & Vendor Support
    • • Move beyond outdated methods and adopt strategies that reduce effort while maintaining compliance.

• • Optimizing IT Compliance Processes
    • • Gain insights into ensuring quality, security, and efficiency without unnecessary complexity.

If you’re responsible for IT system qualification, compliance, or validation, this course will equip you with the latest industry best practices to streamline your approach while minimizing risk and maintaining regulatory alignment.

Join Now!

1. Introduction to GxP Systems & Regulatory Expectations

• • Understanding GxP systems and their impact on compliance
  • Overview of FDA requirements for Computer System Validation (CSV)
  • Introduction to Computer Software Assurance (CSA) and its role in streamlining validation

2. System Development Life Cycle (SDLC) & Validation Approach

• • Key phases of SDLC-based validation
  • Documenting validation efforts: requirements, design, development, testing, and operational maintenance
  • Maintaining a system in a validated state throughout its life cycle

3. Cloud & SaaS Compliance: Vendor Audits & Qualification

• • Best practices for validating cloud-based services and SaaS solutions
  • Conducting vendor audits and Installation Qualification (IQ) for third-party providers
  • Ensuring vendor compliance with FDA requirements

4. Ensuring Data Integrity & Compliance with 21 CFR Part 11

• • Key components of 21 CFR Part 11 compliance for electronic records and signatures
  • Policies and procedures required to support validation and ongoing system maintenance
  • Strategies to assure data integrity in GxP-regulated environments

5. Risk-Based Validation & Compliance Strategy

• • Conducting a risk assessment for computer systems to develop a validation rationale
  • Assessing system size, complexity, business criticality, GAMP 5 category, and failure risk
  • Implementing industry best practices for validation and compliance

6. FDA Inspections & Audit Readiness

• • How to prepare for an FDA inspection or audit of a GxP computer system
  • Ensuring proper documentation and regulatory oversight
  • Performing a thorough vendor audit to verify compliance of products and services

7. Practical Takeaways & Best Practices

• • Industry-proven strategies to optimize validation and compliance
  • Leveraging risk-based approaches to enhance efficiency without compromising quality
  • Maintaining data integrity throughout the entire data life cycle

8. Q&A Session

• • Addressing participant questions
  • Clarifications on regulatory expectations, risk-based approaches, and validation processes

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 & Regulatory Expectations

• • Understanding GxP systems and their impact on compliance
  • Overview of FDA requirements for Computer System Validation (CSV)
  • Introduction to Computer Software Assurance (CSA) and its role in streamlining validation

2. System Development Life Cycle (SDLC) & Validation Approach

• • Key phases of SDLC-based validation
  • Documenting validation efforts: requirements, design, development, testing, and operational maintenance
  • Maintaining a system in a validated state throughout its life cycle

3. Cloud & SaaS Compliance: Vendor Audits & Qualification

• • Best practices for validating cloud-based services and SaaS solutions
  • Conducting vendor audits and Installation Qualification (IQ) for third-party providers
  • Ensuring vendor compliance with FDA requirements

4. Ensuring Data Integrity & Compliance with 21 CFR Part 11

• • Key components of 21 CFR Part 11 compliance for electronic records and signatures
  • Policies and procedures required to support validation and ongoing system maintenance
  • Strategies to assure data integrity in GxP-regulated environments

5. Risk-Based Validation & Compliance Strategy

• • Conducting a risk assessment for computer systems to develop a validation rationale
  • Assessing system size, complexity, business criticality, GAMP 5 category, and failure risk
  • Implementing industry best practices for validation and compliance

6. FDA Inspections & Audit Readiness

• • How to prepare for an FDA inspection or audit of a GxP computer system
  • Ensuring proper documentation and regulatory oversight
  • Performing a thorough vendor audit to verify compliance of products and services

7. Practical Takeaways & Best Practices

• • Industry-proven strategies to optimize validation and compliance
  • Leveraging risk-based approaches to enhance efficiency without compromising quality
  • Maintaining data integrity throughout the entire data life cycle

8. Q&A Session

• • Addressing participant questions
  • Clarifications on regulatory expectations, risk-based approaches, and validation processes

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!

• • IT Compliance And Validation Professionals In Life Sciences
  • Quality Assurance And Quality Control Specialists
  • Regulatory Affairs And Compliance Managers
  • IT And System Administrators In Regulated Industries
  • GxP System Vendors And SaaS Service Providers
  • Clinical And Laboratory Data Management Professionals
  • Pharmaceutical And Medical Device Industry Professionals
  • Anyone Preparing For FDA Audits And Inspections

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

• • IT Compliance And Validation Professionals In Life Sciences
  • Quality Assurance And Quality Control Specialists
  • Regulatory Affairs And Compliance Managers
  • IT And System Administrators In Regulated Industries
  • GxP System Vendors And SaaS Service Providers
  • Clinical And Laboratory Data Management Professionals
  • Pharmaceutical And Medical Device Industry Professionals
  • Anyone Preparing For FDA Audits And Inspections