Instructor :
Carolyn Troiano

Webinar ID:
13560

In today’s digital-first world, ensuring data integrity and privacy is more critical than ever.

Organizations handling sensitive information must comply with stringent regulations like 21 CFR Part 11, Annex 11, and GDPR to maintain compliance, security, and trust.

This comprehensive training delves into the fundamental principles and regulatory requirements governing electronic records, signatures, and data protection in life sciences, pharmaceuticals, and healthcare industries.

Participants will gain a clear understanding of how these regulations impact data management and what steps organizations must take to remain compliant.

Key Topics Covered:

• • Understanding 21 CFR Part 11 & Annex 11
    • • Learn the requirements for electronic records and electronic signatures in regulated industries.

• • Navigating GDPR Compliance
    • • Explore how GDPR protects personal data and what it means for organizations handling EU citizens’ information.

• • California Privacy Laws (CPRA) vs. GDPR & HIPAA
    • • Compare the nuances between GDPR, HIPAA, and CPRA, and understand their impact on data protection strategies.

• • Achieving & Maintaining Compliance
    • • Discover best practices, risk mitigation strategies, and key industry insights to ensure regulatory adherence.

By the end of this training, participants will have actionable knowledge to implement robust data governance frameworks, safeguard sensitive information, and stay ahead of evolving compliance standards.

Enroll Now!

In today’s digital-first world, ensuring data integrity and privacy is more critical than ever.

Organizations handling sensitive information must comply with stringent regulations like 21 CFR Part 11, Annex 11, and GDPR to maintain compliance, security, and trust.

This comprehensive training delves into the fundamental principles and regulatory requirements governing electronic records, signatures, and data protection in life sciences, pharmaceuticals, and healthcare industries.

Participants will gain a clear understanding of how these regulations impact data management and what steps organizations must take to remain compliant.

Key Topics Covered:

• • Understanding 21 CFR Part 11 & Annex 11
    • • Learn the requirements for electronic records and electronic signatures in regulated industries.

• • Navigating GDPR Compliance
    • • Explore how GDPR protects personal data and what it means for organizations handling EU citizens’ information.

• • California Privacy Laws (CPRA) vs. GDPR & HIPAA
    • • Compare the nuances between GDPR, HIPAA, and CPRA, and understand their impact on data protection strategies.

• • Achieving & Maintaining Compliance
    • • Discover best practices, risk mitigation strategies, and key industry insights to ensure regulatory adherence.

By the end of this training, participants will have actionable knowledge to implement robust data governance frameworks, safeguard sensitive information, and stay ahead of evolving compliance standards.

Enroll Now!

Navigating the complex landscape of data integrity, privacy regulations, and compliance requirements can be overwhelming.

Whether you work in pharmaceuticals, medical devices, biologics, or other FDA-regulated industries, understanding how to properly handle electronic records, data security, and system validation is crucial to avoiding compliance risks.

This training is designed to help professionals like QA/QC specialists, IT and compliance officers, regulatory affairs experts, and validation engineers confidently manage data privacy and integrity across global regulations, including GDPR, HIPAA, CPRA, and FDA requirements.

Key Takeaways:

• • Understand Global Data Privacy Laws
    • • Learn how GDPR, HIPAA, and CPRA impact data management in regulated industries.

• • Master 21 CFR Part 11 & Annex 11 Compliance
    • • Ensure your electronic records and signatures meet FDA and EU expectations.

• • Enhance Computer System Validation (CSV) & Assurance (CSA) Compliance
    • • Gain insights into FDA’s evolving approach to software validation.

• • Align with GAMP®5 Standards
    • • Stay updated on industry best practices for system validation and compliance.

By attending, you’ll gain the expert knowledge needed to ensure regulatory compliance, mitigate risks, and enhance data integrity practices within your organization.

Join Now!

Navigating the complex landscape of data integrity, privacy regulations, and compliance requirements can be overwhelming.

Whether you work in pharmaceuticals, medical devices, biologics, or other FDA-regulated industries, understanding how to properly handle electronic records, data security, and system validation is crucial to avoiding compliance risks.

This training is designed to help professionals like QA/QC specialists, IT and compliance officers, regulatory affairs experts, and validation engineers confidently manage data privacy and integrity across global regulations, including GDPR, HIPAA, CPRA, and FDA requirements.

Key Takeaways:

• • Understand Global Data Privacy Laws
    • • Learn how GDPR, HIPAA, and CPRA impact data management in regulated industries.

• • Master 21 CFR Part 11 & Annex 11 Compliance
    • • Ensure your electronic records and signatures meet FDA and EU expectations.

• • Enhance Computer System Validation (CSV) & Assurance (CSA) Compliance
    • • Gain insights into FDA’s evolving approach to software validation.

• • Align with GAMP®5 Standards
    • • Stay updated on industry best practices for system validation and compliance.

By attending, you’ll gain the expert knowledge needed to ensure regulatory compliance, mitigate risks, and enhance data integrity practices within your organization.

Join Now!

1. Introduction to Data Integrity & Compliance

• • Overview of 21 CFR Part 11, Annex 11, and GDPR
  • Key challenges in data privacy, security, and regulatory compliance
  • Understanding the impact of non-compliance on data integrity, product quality, and patient safety

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

• • Exploring traditional CSV vs. FDA’s CSA draft guidance (September 2022)
  • Understanding key differences, similarities, and industry impact
  • Aligning validation strategies with FDA expectations

3. System Development Life Cycle (SDLC) & Validation Approaches

• • Traditional Waterfall vs. Agile Validation Methodologies
    • • Phased approach vs. 2–3-week sprint models

• • Conducting risk-based validation using SDLC principles
  • Implementing validation for:
    • • Computer Off-the-Shelf (COTS) software
      • Cloud-based systems
      • Software-as-a-Service (SaaS) solutions

4. GAMP®5 Framework & Risk-Based Testing

• • Understanding GAMP®5 guidance from ISPE
  • Software categorization and testing strategies based on risk level
  • Ensuring compliance with data integrity principles in computerized systems

5. Application of 21 CFR Part 11 & Annex 11

• • Overview of electronic records and electronic signatures compliance
  • Understanding data integrity requirements (FDA’s December 2018 guidance)
  • Implementing ALCOA+ principles to maintain regulatory compliance
    • • Attributable, Legible, Contemporaneous, Original, Accurate
      • Complete, Consistent, Enduring, Available

6. Preparing for FDA Inspections & Vendor Audits

• • Best practices to prepare for regulatory inspections
  • Auditing vendors of computer system hardware, software, tools, and services
  • Addressing common compliance pitfalls and mitigating risks

7. Industry Best Practices & Risk Assessment Strategies

• • Establishing data governance frameworks for GxP compliance
  • Applying risk-based approaches to validation and system management
  • Leveraging compliance-driven best practices to future-proof operations

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 Data Integrity & Compliance

• • Overview of 21 CFR Part 11, Annex 11, and GDPR
  • Key challenges in data privacy, security, and regulatory compliance
  • Understanding the impact of non-compliance on data integrity, product quality, and patient safety

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

• • Exploring traditional CSV vs. FDA’s CSA draft guidance (September 2022)
  • Understanding key differences, similarities, and industry impact
  • Aligning validation strategies with FDA expectations

3. System Development Life Cycle (SDLC) & Validation Approaches

• • Traditional Waterfall vs. Agile Validation Methodologies
    • • Phased approach vs. 2–3-week sprint models

• • Conducting risk-based validation using SDLC principles
  • Implementing validation for:
    • • Computer Off-the-Shelf (COTS) software
      • Cloud-based systems
      • Software-as-a-Service (SaaS) solutions

4. GAMP®5 Framework & Risk-Based Testing

• • Understanding GAMP®5 guidance from ISPE
  • Software categorization and testing strategies based on risk level
  • Ensuring compliance with data integrity principles in computerized systems

5. Application of 21 CFR Part 11 & Annex 11

• • Overview of electronic records and electronic signatures compliance
  • Understanding data integrity requirements (FDA’s December 2018 guidance)
  • Implementing ALCOA+ principles to maintain regulatory compliance
    • • Attributable, Legible, Contemporaneous, Original, Accurate
      • Complete, Consistent, Enduring, Available

6. Preparing for FDA Inspections & Vendor Audits

• • Best practices to prepare for regulatory inspections
  • Auditing vendors of computer system hardware, software, tools, and services
  • Addressing common compliance pitfalls and mitigating risks

7. Industry Best Practices & Risk Assessment Strategies

• • Establishing data governance frameworks for GxP compliance
  • Applying risk-based approaches to validation and system management
  • Leveraging compliance-driven best practices to future-proof operations

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!

• • Regulatory Affairs And Compliance Professionals In Life Sciences
  • Quality Assurance And Quality Control Specialists
  • IT And Data Integrity Compliance Officers
  • Validation Engineers And System Validation Specialists
  • Pharmaceutical, Biotech, And Medical Device Professionals
  • Clinical Research And Laboratory Management Teams
  • Manufacturing And Supply Chain Compliance Managers
  • Auditors And Professionals Preparing For FDA Inspections

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

• • Regulatory Affairs And Compliance Professionals In Life Sciences
  • Quality Assurance And Quality Control Specialists
  • IT And Data Integrity Compliance Officers
  • Validation Engineers And System Validation Specialists
  • Pharmaceutical, Biotech, And Medical Device Professionals
  • Clinical Research And Laboratory Management Teams
  • Manufacturing And Supply Chain Compliance Managers
  • Auditors And Professionals Preparing For FDA Inspections