Instructor :
Carolyn Troiano

Webinar ID:
11616

Navigating the complex world of FDA regulations doesn’t have to be daunting.

This comprehensive training on 21 CFR Part 11 compliance demystifies the critical requirements governing electronic records and electronic signatures within computerized systems used in regulated environments.

Designed specifically for life sciences professionals, this course equips you with the essential knowledge to meet FDA expectations and ensure your systems are audit-ready.

Through a blend of expert guidance and practical insights, you’ll gain a solid understanding of:

• • Key regulatory requirements for electronic records and signatures under 21 CFR Part 11
  • Risk mitigation strategies to safeguard data integrity and avoid compliance pitfalls
  • Validation techniques for computerized systems, ensuring they meet FDA standards
  • Best practices for user access controls, audit trails, and data security protocols
  • The role of QA, IT, and compliance teams in maintaining ongoing system validation and compliance

By the end of this session, you’ll be prepared to confidently manage compliance challenges across your organization’s digital systems, minimize regulatory risks, and align with the FDA’s evolving expectations.

Stay ahead in an increasingly digital and regulated landscape with the expertise and tools to ensure your systems meet the highest standards of compliance.

Enroll Now!

Navigating the complex world of FDA regulations doesn’t have to be daunting.

This comprehensive training on 21 CFR Part 11 compliance demystifies the critical requirements governing electronic records and electronic signatures within computerized systems used in regulated environments.

Designed specifically for life sciences professionals, this course equips you with the essential knowledge to meet FDA expectations and ensure your systems are audit-ready.

Through a blend of expert guidance and practical insights, you’ll gain a solid understanding of:

• • Key regulatory requirements for electronic records and signatures under 21 CFR Part 11
  • Risk mitigation strategies to safeguard data integrity and avoid compliance pitfalls
  • Validation techniques for computerized systems, ensuring they meet FDA standards
  • Best practices for user access controls, audit trails, and data security protocols
  • The role of QA, IT, and compliance teams in maintaining ongoing system validation and compliance

By the end of this session, you’ll be prepared to confidently manage compliance challenges across your organization’s digital systems, minimize regulatory risks, and align with the FDA’s evolving expectations.

Stay ahead in an increasingly digital and regulated landscape with the expertise and tools to ensure your systems meet the highest standards of compliance.

Enroll Now!

In an era where digitalization reigns supreme, non-compliance with 21 CFR Part 11 can lead to costly corrective actions, hefty penalties, and significant reputational damage that can jeopardize your competitive position.

“Did you know? FDA warning letters citing 21 CFR Part 11 issues have surged by 8% in the last two years. Ignorance is no longer bliss – it’s a ticking time bomb.”

Why This Seminar is Crucial:

• • FDA Mandate:
    • • The FDA requires all computer systems handling regulated data to be validated according to their guidance on computerized systems. This guidance, first issued in 1983, remains crucial today, despite evolving technologies.

• • Comprehensive Understanding:
    • • This seminar offers an in-depth exploration of the FDA’s 21 CFR Part 11 guidance on electronic records and electronic signatures (ER/ES) for computer systems under FDA regulation.

• • Strategic Validation:
    • • Learn how to develop a robust validation strategy that ensures your system meets FDA requirements and maintains a validated state throughout its entire life cycle, from conception to retirement.

• • Tailored Approach:
    • • Understand how to apply ER/ES capability based on specific cases and assess the risks of non-compliance, ensuring your approach is both effective and efficient.

Why You Can’t Afford to Miss This:

By attending this seminar, you’ll gain the essential knowledge to identify, address, and avoid potential pitfalls, safeguarding the integrity, reliability, and legal compliance of your digital records.

Enroll Now!

In an era where digitalization reigns supreme, non-compliance with 21 CFR Part 11 can lead to costly corrective actions, hefty penalties, and significant reputational damage that can jeopardize your competitive position.

“Did you know? FDA warning letters citing 21 CFR Part 11 issues have surged by 8% in the last two years. Ignorance is no longer bliss – it’s a ticking time bomb.”

Why This Seminar is Crucial:

• • FDA Mandate:
    • • The FDA requires all computer systems handling regulated data to be validated according to their guidance on computerized systems. This guidance, first issued in 1983, remains crucial today, despite evolving technologies.

• • Comprehensive Understanding:
    • • This seminar offers an in-depth exploration of the FDA’s 21 CFR Part 11 guidance on electronic records and electronic signatures (ER/ES) for computer systems under FDA regulation.

• • Strategic Validation:
    • • Learn how to develop a robust validation strategy that ensures your system meets FDA requirements and maintains a validated state throughout its entire life cycle, from conception to retirement.

• • Tailored Approach:
    • • Understand how to apply ER/ES capability based on specific cases and assess the risks of non-compliance, ensuring your approach is both effective and efficient.

Why You Can’t Afford to Miss This:

By attending this seminar, you’ll gain the essential knowledge to identify, address, and avoid potential pitfalls, safeguarding the integrity, reliability, and legal compliance of your digital records.

Enroll Now!

Session 1 (90 Minutes): Understanding FDA Oversight and Achieving 21 CFR Part 11 Compliance

• • FDA Regulatory Oversight
    • • Key FDA regulations governing electronic records and signatures

• • System Development Life Cycle (SDLC) Methodology
    • • Framework for managing system implementation and compliance

• • Computer System Validation (CSV)
    • • Principles and practices to ensure system accuracy, reliability, and integrity

• • GAMP 5 Software Categorization
    • • Understanding software classification to guide validation efforts

• • System Risk Assessment
    • • Identifying and mitigating compliance risks in computerized systems

• • 21 CFR Part 11 Compliance Essentials
    • • Defining Electronic Records (ER) and Electronic Signatures (ES)
      • Core requirements for secure, compliant system operations

Session 2 (90 Minutes): Securing Data Integrity and Preparing for FDA Audits

• • Security and Access Management
    • • Implementing access control, change control, and audit trail mechanisms

• • Validation Documentation Essentials
    • • Creating comprehensive, FDA-compliant documentation for system validation

• • 7 Most Common Validation Issues
    • • Identifying frequent pitfalls and how to avoid them

• • FDA Audit Preparation
    • • Proven strategies to ensure your systems and documentation are audit-ready

• • Industry Best Practices and Common Pitfalls
    • • Leveraging case studies and examples for effective compliance

• • Interactive Q&A Session
    • • Address specific participant questions and real-world scenarios

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

Session 1 (90 Minutes): Understanding FDA Oversight and Achieving 21 CFR Part 11 Compliance

• • FDA Regulatory Oversight
    • • Key FDA regulations governing electronic records and signatures

• • System Development Life Cycle (SDLC) Methodology
    • • Framework for managing system implementation and compliance

• • Computer System Validation (CSV)
    • • Principles and practices to ensure system accuracy, reliability, and integrity

• • GAMP 5 Software Categorization
    • • Understanding software classification to guide validation efforts

• • System Risk Assessment
    • • Identifying and mitigating compliance risks in computerized systems

• • 21 CFR Part 11 Compliance Essentials
    • • Defining Electronic Records (ER) and Electronic Signatures (ES)
      • Core requirements for secure, compliant system operations

Session 2 (90 Minutes): Securing Data Integrity and Preparing for FDA Audits

• • Security and Access Management
    • • Implementing access control, change control, and audit trail mechanisms

• • Validation Documentation Essentials
    • • Creating comprehensive, FDA-compliant documentation for system validation

• • 7 Most Common Validation Issues
    • • Identifying frequent pitfalls and how to avoid them

• • FDA Audit Preparation
    • • Proven strategies to ensure your systems and documentation are audit-ready

• • Industry Best Practices and Common Pitfalls
    • • Leveraging case studies and examples for effective compliance

• • Interactive Q&A Session
    • • Address specific participant questions and real-world scenarios

BONUS:

1. 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

Maximize The Learning Experience in A Group Setting!

• • Leaders Seeking Practical Strategies to Ensure Team Compliance with FDA Standards
  • Department Heads Aiming to Streamline Compliance Processes Across Their Teams
  • Professionals Overwhelmed by Regulatory Jargon Needing Clearer Compliance Guidance
  • Training Heads Designing Learning Paths to Build Team Compliance Expertise
  • HR Professionals Developing Programs to Address Compliance Knowledge Gaps
  • Quality Assurance Experts Focused on Minimizing Risks of Non-Compliance
  • IT Professionals Managing the Validation and Security of Computer Systems
  • Compliance Officers Ensuring Seamless Integration of ER/ES in Operations
  • Auditors and Inspectors Preparing for Flawless FDA Audit Readiness

Maximize The Learning Experience in A Group Setting!

• • Leaders Seeking Practical Strategies to Ensure Team Compliance with FDA Standards
  • Department Heads Aiming to Streamline Compliance Processes Across Their Teams
  • Professionals Overwhelmed by Regulatory Jargon Needing Clearer Compliance Guidance
  • Training Heads Designing Learning Paths to Build Team Compliance Expertise
  • HR Professionals Developing Programs to Address Compliance Knowledge Gaps
  • Quality Assurance Experts Focused on Minimizing Risks of Non-Compliance
  • IT Professionals Managing the Validation and Security of Computer Systems
  • Compliance Officers Ensuring Seamless Integration of ER/ES in Operations
  • Auditors and Inspectors Preparing for Flawless FDA Audit Readiness