Instructor :
Charles H. Paul

Webinar ID:
13913

Maintaining data integrity is a cornerstone of compliance in regulated life sciences environments.

This expert-led training, delivers a clear, actionable understanding of how to meet global regulatory expectations across Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) settings.

Participants will explore the critical elements of ALCOA+ principles, the foundation of reliable and trustworthy data systems.

The course breaks down complex regulatory guidance into digestible insights, drawing from the latest standards set by the FDA, EMA, and MHRA.

Through practical, real-world examples and case studies, this session will examine:

• • Core data integrity risks in both paper-based and electronic systems
  • Key distinctions and compliance challenges between electronic and manual data controls
  • Audit readiness strategies and how to prepare for regulator inspections
  • Enforcement trends and lessons learned from recent warning letters and findings
  • Proven methods to strengthen data governance across departments

By the end of the session, attendees will walk away with a strong framework to identify vulnerabilities, close compliance gaps, and ensure consistent, high-quality data practices that align with global regulatory expectations.

Enroll Now!

Maintaining data integrity is a cornerstone of compliance in regulated life sciences environments.

This expert-led training, delivers a clear, actionable understanding of how to meet global regulatory expectations across Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) settings.

Participants will explore the critical elements of ALCOA+ principles, the foundation of reliable and trustworthy data systems.

The course breaks down complex regulatory guidance into digestible insights, drawing from the latest standards set by the FDA, EMA, and MHRA.

Through practical, real-world examples and case studies, this session will examine:

• • Core data integrity risks in both paper-based and electronic systems
  • Key distinctions and compliance challenges between electronic and manual data controls
  • Audit readiness strategies and how to prepare for regulator inspections
  • Enforcement trends and lessons learned from recent warning letters and findings
  • Proven methods to strengthen data governance across departments

By the end of the session, attendees will walk away with a strong framework to identify vulnerabilities, close compliance gaps, and ensure consistent, high-quality data practices that align with global regulatory expectations.

Enroll Now!

Regulatory bodies like the FDA, EMA, and MHRA are placing increased scrutiny on data integrity—and non-compliance can lead to warning letters, operational disruptions, and reputational damage.

This training offers more than just theory. It delivers practical, expert-driven strategies to help you:

• • Identify and address data integrity risks before they escalate
  • Translate ALCOA+ principles into actionable practices
  • Build resilient systems that are inspection-ready at any time
  • Reduce the risk of costly remediation and enforcement actions
  • Enhance your role as a compliance leader in your organization

Whether you’re in manufacturing, quality, or clinical operations, this course equips you with the tools and confidence to stay ahead of evolving global compliance expectations and safeguard the integrity of your regulated data.

Join Now!

Regulatory bodies like the FDA, EMA, and MHRA are placing increased scrutiny on data integrity—and non-compliance can lead to warning letters, operational disruptions, and reputational damage.

This training offers more than just theory. It delivers practical, expert-driven strategies to help you:

• • Identify and address data integrity risks before they escalate
  • Translate ALCOA+ principles into actionable practices
  • Build resilient systems that are inspection-ready at any time
  • Reduce the risk of costly remediation and enforcement actions
  • Enhance your role as a compliance leader in your organization

Whether you’re in manufacturing, quality, or clinical operations, this course equips you with the tools and confidence to stay ahead of evolving global compliance expectations and safeguard the integrity of your regulated data.

Join Now!

1. Introduction (10 minutes)

• • Welcome and Speaker Overview
    • Introduction to the expert speaker and session objectives

• • Understanding the Importance of Data Integrity
    • What is data integrity and why it matters in GMP and GCP
    • Real-world consequences of data integrity failures on product safety and compliance

• • Regulatory Framework Snapshot
    • Overview of key regulatory bodies and their guidance:
      • FDA – 21 CFR Part 11, CGMP Guidance on Data Integrity
      • EMA – EudraLex Volume 4, Annex 11 & 15
      • MHRA – GxP Data Integrity Guidance

• • • Comparison of global expectations and compliance focus areas

2. Core Principles of Data Integrity (15 minutes)

• • The ALCOA+ Framework
    • Deep dive into the foundational principles:
      • Attributable, Legible, Contemporaneous, Original, Accurate
        + Complete, Consistent, Enduring, Available

• • Common Risks and Challenges
    • Frequent data integrity failures in GMP and GCP environments
    • Contributing factors: human error, system design flaws, lack of oversight
    • Case examples of enforcement actions and compliance gaps

3. Compliance Strategies and Best Practices (20 minutes)

• • Policy and Procedure Alignment
    • Role of SOPs, staff training, and clear accountability

• • Electronic vs. Paper-Based Controls
    • Key regulatory requirements for electronic data systems (21 CFR Part 11, Annex 11)
    • Audit trails, data backups, and access management essentials

• • Building Effective Data Governance
    • Establishing oversight mechanisms and cross-functional responsibilities

• • Regulatory Inspections and Audit Readiness
    • What regulators look for in audits
    • Preparing documentation, responding to findings, and corrective actions

4. Case Studies and Lessons Learned (10 minutes)

• • Enforcement Insights
    • Examples from FDA warning letters, EMA/MHRA findings
    • Actionable lessons from past industry missteps

• • Interactive Q&A Session
    • Open discussion with the expert
    • Addressing participant challenges and practical concerns

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 (10 minutes)

• • Welcome and Speaker Overview
    • • Introduction to the expert speaker and session objectives

• • Understanding the Importance of Data Integrity
    • • What is data integrity and why it matters in GMP and GCP
      • Real-world consequences of data integrity failures on product safety and compliance

• • Regulatory Framework Snapshot
    • Overview of key regulatory bodies and their guidance:
      • FDA – 21 CFR Part 11, CGMP Guidance on Data Integrity
      • EMA – EudraLex Volume 4, Annex 11 & 15
      • MHRA – GxP Data Integrity Guidance

• • • Comparison of global expectations and compliance focus areas

2. Core Principles of Data Integrity (15 minutes)

• • The ALCOA+ Framework
    • Deep dive into the foundational principles:
      • Attributable, Legible, Contemporaneous, Original, Accurate
        + Complete, Consistent, Enduring, Available

• • Common Risks and Challenges
    • • Frequent data integrity failures in GMP and GCP environments
      • Contributing factors: human error, system design flaws, lack of oversight
      • Case examples of enforcement actions and compliance gaps

3. Compliance Strategies and Best Practices (20 minutes)

• • Policy and Procedure Alignment
    • Role of SOPs, staff training, and clear accountability

• • Electronic vs. Paper-Based Controls
    • Key regulatory requirements for electronic data systems (21 CFR Part 11, Annex 11)
    • Audit trails, data backups, and access management essentials

• • Building Effective Data Governance
    • Establishing oversight mechanisms and cross-functional responsibilities

• • Regulatory Inspections and Audit Readiness
    • What regulators look for in audits
    • Preparing documentation, responding to findings, and corrective actions

4. Case Studies and Lessons Learned (10 minutes)

• • Enforcement Insights
    • Examples from FDA warning letters, EMA/MHRA findings
    • Actionable lessons from past industry missteps

• • Interactive Q&A Session
    • Open discussion with the expert
    • Addressing participant challenges and practical concerns

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 Professionals In Pharma And Biotech
  • Regulatory Affairs Managers In Life Sciences Companies
  • Clinical Research Associates And Study Coordinators
  • Compliance Officers Managing GxP Requirements Globally
  • Data Governance And Documentation Control Specialists
  • Manufacturing Supervisors In GMP-Regulated Environments
  • Auditors Preparing For Regulatory Health Authority Inspections
  • R&D Teams Handling Clinical Or Manufacturing Data

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

• • Quality Assurance Professionals In Pharma And Biotech
  • Regulatory Affairs Managers In Life Sciences Companies
  • Clinical Research Associates And Study Coordinators
  • Compliance Officers Managing GxP Requirements Globally
  • Data Governance And Documentation Control Specialists
  • Manufacturing Supervisors In GMP-Regulated Environments
  • Auditors Preparing For Regulatory Health Authority Inspections
  • R&D Teams Handling Clinical Or Manufacturing Data