Instructor :
Charles H. Paul

Webinar ID:
13893

Gain a comprehensive understanding of the regulatory expectations for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device sectors with this expert-led webinar.

This session unpacks the essential elements of FDA’s 21 CFR Part 11 and EU Annex 11, offering clarity on how these frameworks impact system design, validation, and compliance efforts.

Participants will learn how to interpret and apply regulatory requirements across different electronic systems used in GxP environments.

Key topics covered include:

• • Core principles of 21 CFR Part 11 and EU Annex 11
  • System validation and maintaining validated state
  • Managing audit trails and ensuring data integrity
  • Cybersecurity and access controls for regulated systems
  • Recognizing and avoiding common compliance pitfalls
  • Implementing best practices for sustainable electronic recordkeeping

The course will also include real-world case studies and analysis of recent enforcement actions to highlight practical compliance strategies and the consequences of non-compliance.

Designed for professionals seeking operational readiness, this session equips you with the knowledge to confidently manage electronic systems and stay aligned with both FDA and EU regulatory expectations.

Enroll Now!

Gain a comprehensive understanding of the regulatory expectations for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device sectors with this expert-led webinar.

This session unpacks the essential elements of FDA’s 21 CFR Part 11 and EU Annex 11, offering clarity on how these frameworks impact system design, validation, and compliance efforts.

Participants will learn how to interpret and apply regulatory requirements across different electronic systems used in GxP environments.

Key topics covered include:

• • Core principles of 21 CFR Part 11 and EU Annex 11
  • System validation and maintaining validated state
  • Managing audit trails and ensuring data integrity
  • Cybersecurity and access controls for regulated systems
  • Recognizing and avoiding common compliance pitfalls
  • Implementing best practices for sustainable electronic recordkeeping

The course will also include real-world case studies and analysis of recent enforcement actions to highlight practical compliance strategies and the consequences of non-compliance.

Designed for professionals seeking operational readiness, this session equips you with the knowledge to confidently manage electronic systems and stay aligned with both FDA and EU regulatory expectations.

Enroll Now!

Navigating compliance with FDA’s 21 CFR Part 11 and EU Annex 11 can be complex, especially as digital systems evolve and regulatory scrutiny intensifies.

This training is designed to help you cut through the complexity and apply the regulations with confidence and clarity.

By attending, you will:

• • Address critical compliance gaps in electronic recordkeeping systems
  • Gain practical strategies to avoid costly inspection findings and enforcement actions
  • Learn to implement robust system validation, audit trails, and cybersecurity controls
  • Understand how to interpret regulations in real-world scenarios through case studies and regulator insights

Whether you’re preparing for an audit or strengthening internal SOPs, this session delivers actionable guidance you can apply immediately to reduce risk and improve regulatory readiness.

Join Now!

Navigating compliance with FDA’s 21 CFR Part 11 and EU Annex 11 can be complex, especially as digital systems evolve and regulatory scrutiny intensifies.

This training is designed to help you cut through the complexity and apply the regulations with confidence and clarity.

By attending, you will:

• • Address critical compliance gaps in electronic recordkeeping systems
  • Gain practical strategies to avoid costly inspection findings and enforcement actions
  • Learn to implement robust system validation, audit trails, and cybersecurity controls
  • Understand how to interpret regulations in real-world scenarios through case studies and regulator insights

Whether you’re preparing for an audit or strengthening internal SOPs, this session delivers actionable guidance you can apply immediately to reduce risk and improve regulatory readiness.

Join Now!

1. Introduction to Electronic Record Compliance (10 minutes)

• • Welcome and Speaker Introduction
    • • Brief background of the speaker and regulatory expertise
      • Overview of session goals and learning objectives

• • Importance of Electronic Record Compliance
    • • Shift from paper-based to electronic systems
      • Role of 21 CFR Part 11 and EU Annex 11 in ensuring data integrity and security
      • Risks and consequences of non-compliance

• • Regulatory Framework Overview
    • • Scope and applicability of FDA’s 21 CFR Part 11 and EU Annex 11
      • Key similarities and distinctions between the two
      • Relevance for pharma, biotech, and medical device industries

2. Key Requirements of 21 CFR Part 11 and EU Annex 11 (20 minutes)

• • Core Principles of 21 CFR Part 11
    • • Defining electronic records and electronic signatures
      • Validation of electronic systems
      • Managing audit trails and ensuring data integrity
      • Implementing access controls and security measures
      • Addressing legacy systems and hybrid models

• • Core Principles of EU Annex 11
    • • Risk-based approach to compliance
      • System validation and third-party supplier management
      • Data handling and archiving protocols
      • IT governance, business continuity, and GAMP 5 alignment

3. Compliance Strategies and Best Practices (20 minutes)

• • Validation and Qualification of Systems
    • • Crafting compliant validation plans
      • Risk-based validation and essential documentation

• • Data Integrity and Audit Readiness
    • • Configuring audit trails and monitoring controls
      • Performing regular system reviews and assessments

• • Access Controls and Cybersecurity
    • • User authentication and electronic signature policies
      • Role-based access and cybersecurity defense strategies

• • Inspection Readiness and Pitfall Avoidance
    • • What regulators expect during inspections
      • Real-world enforcement case examples and lessons learned

4. Case Studies and Practical Insights (5 minutes)

• • Real-World Regulatory Challenges
    • • Recent FDA warning letters and EU inspection findings
      • Common compliance failures and actionable takeaways

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 Electronic Record Compliance (10 minutes)

• • Welcome and Speaker Introduction
    • • Brief background of the speaker and regulatory expertise
      • Overview of session goals and learning objectives

• • Importance of Electronic Record Compliance
    • • Shift from paper-based to electronic systems
      • Role of 21 CFR Part 11 and EU Annex 11 in ensuring data integrity and security
      • Risks and consequences of non-compliance

• • Regulatory Framework Overview
    • • Scope and applicability of FDA’s 21 CFR Part 11 and EU Annex 11
      • Key similarities and distinctions between the two
      • Relevance for pharma, biotech, and medical device industries

2. Key Requirements of 21 CFR Part 11 and EU Annex 11 (20 minutes)

• • Core Principles of 21 CFR Part 11
    • • Defining electronic records and electronic signatures
      • Validation of electronic systems
      • Managing audit trails and ensuring data integrity
      • Implementing access controls and security measures
      • Addressing legacy systems and hybrid models

• • Core Principles of EU Annex 11
    • • Risk-based approach to compliance
      • System validation and third-party supplier management
      • Data handling and archiving protocols
      • IT governance, business continuity, and GAMP 5 alignment

3. Compliance Strategies and Best Practices (20 minutes)

• • Validation and Qualification of Systems
    • • Crafting compliant validation plans
      • Risk-based validation and essential documentation

• • Data Integrity and Audit Readiness
    • • Configuring audit trails and monitoring controls
      • Performing regular system reviews and assessments

• • Access Controls and Cybersecurity
    • • User authentication and electronic signature policies
      • Role-based access and cybersecurity defense strategies

• • Inspection Readiness and Pitfall Avoidance
    • • What regulators expect during inspections
      • Real-world enforcement case examples and lessons learned

4. Case Studies and Practical Insights (5 minutes)

• • Real-World Regulatory Challenges
    • • Recent FDA warning letters and EU inspection findings
      • Common compliance failures and actionable takeaways

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 Assurance And Compliance Professionals
  • Regulatory Affairs And Validation Specialists
  • IT Managers In GxP-Regulated Environments
  • Clinical And Laboratory Data Management Teams
  • Pharmaceutical And Biotech Project Managers
  • Medical Device Regulatory Compliance Leads
  • Manufacturing And Operations Quality Managers
  • Consultants In Life Sciences Compliance Fields

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

• • Quality Assurance And Compliance Professionals
  • Regulatory Affairs And Validation Specialists
  • IT Managers In GxP-Regulated Environments
  • Clinical And Laboratory Data Management Teams
  • Pharmaceutical And Biotech Project Managers
  • Medical Device Regulatory Compliance Leads
  • Manufacturing And Operations Quality Managers
  • Consultants In Life Sciences Compliance Fields