Instructor :
David Nettelton

Webinar ID:
3772

In today’s rapidly evolving regulatory environment, staying ahead of FDA software validation requirements is more critical than ever. This webinar provides a comprehensive deep dive into the challenges and solutions surrounding FDA software validation and verification.

With 2024 bringing major regulatory shifts, preparation is key. This interactive session will equip you with the knowledge and tools to navigate these changes smoothly, ensuring your systems stay compliant and avoiding costly mistakes.

What You Will Gain:

• • Expert Guidance: Led by industry authority David Nettleton, renowned for his expertise in Computer System Validation.
  • Latest Updates: Stay informed on the most recent FDA software validation regulations for 2024.
  • Compliance Mastery: Understand the essentials of 21 CFR Part 11, GAMP, and key validation processes.
  • Practical Problem-Solving: Learn how to identify and avoid the 6 most common compliance pitfalls.
  • Industry Standards Expertise: Master the crucial Part 11 standards, including SOPs, data security, audit trails, and electronic signatures.

As technological complexity and regulatory demands continue to rise, knowing how to effectively validate software in compliance with FDA standards is essential.

Whether you’re refining your existing approach or looking to gain deeper insights into emerging trends, this webinar is the key to achieving regulatory success.

Secure your spot now and arm yourself with the tools to navigate 2024-25’s FDA software validation challenges, ensuring your organization’s compliance and success.

Join Now!

In today’s rapidly evolving regulatory environment, staying ahead of FDA software validation requirements is more critical than ever. This webinar provides a comprehensive deep dive into the challenges and solutions surrounding FDA software validation and verification.

With 2024 bringing major regulatory shifts, preparation is key. This interactive session will equip you with the knowledge and tools to navigate these changes smoothly, ensuring your systems stay compliant and avoiding costly mistakes.

What You Will Gain:

• • Expert Guidance: Led by industry authority David Nettleton, renowned for his expertise in Computer System Validation.
  • Latest Updates: Stay informed on the most recent FDA software validation regulations for 2024.
  • Compliance Mastery: Understand the essentials of 21 CFR Part 11, GAMP, and key validation processes.
  • Practical Problem-Solving: Learn how to identify and avoid the 6 most common compliance pitfalls.
  • Industry Standards Expertise: Master the crucial Part 11 standards, including SOPs, data security, audit trails, and electronic signatures.

As technological complexity and regulatory demands continue to rise, knowing how to effectively validate software in compliance with FDA standards is essential.

Whether you’re refining your existing approach or looking to gain deeper insights into emerging trends, this webinar is the key to achieving regulatory success.

Secure your spot now and arm yourself with the tools to navigate 2024-25’s FDA software validation challenges, ensuring your organization’s compliance and success.

Join Now!

The landscape of FDA software validation is daunting and constantly changing.

This webinar is your opportunity to not only understand these changes but leverage them for operational excellence and career advancement.

With over 60% of Life Sciences companies citing regulatory updates as a top concern, this session will equip you with the tools and insights needed to navigate these challenges. Studies show that companies who adapt to regulatory changes quickly see a 15% boost in operational efficiency.

Don’t get left behind—this course will help you become one of these high performers.

Why You Should Attend:

• • Stay Ahead of 2024 Changes: Understand the implications of the 2024 FDA software validation updates and what they mean for your business.
  • Avoid Costly Non-Compliance: Learn how to sidestep common pitfalls and prevent expensive regulatory mistakes from industry experts with real-world experience.
  • Proven Problem-Solving Strategies: Discover actionable strategies to avoid the 6 most common compliance failures in Part 11 and Annex 11.
  • Master Documentation: Learn how to create precise, compliant documentation that supports data integrity requirements—boosting your efficiency and reducing overhead.
  • Expert-Led Training: Gain invaluable insights from David Nettleton, a recognized leader in Computer System Validation, who will provide practical, hands-on advice.

Whether you’re looking to demystify the validation process, strengthen your compliance, or stay ahead of the regulatory curve, this webinar offers the expert guidance you need.

Join us and take a proactive step toward compliance excellence.

Enroll Now and ensure your team is prepared for 2024-25.

The landscape of FDA software validation is daunting and constantly changing.

This webinar is your opportunity to not only understand these changes but leverage them for operational excellence and career advancement.

With over 60% of Life Sciences companies citing regulatory updates as a top concern, this session will equip you with the tools and insights needed to navigate these challenges. Studies show that companies who adapt to regulatory changes quickly see a 15% boost in operational efficiency.

Don’t get left behind—this course will help you become one of these high performers.

Why You Should Attend:

• • Stay Ahead of 2024 Changes: Understand the implications of the 2024 FDA software validation updates and what they mean for your business.
  • Avoid Costly Non-Compliance: Learn how to sidestep common pitfalls and prevent expensive regulatory mistakes from industry experts with real-world experience.
  • Proven Problem-Solving Strategies: Discover actionable strategies to avoid the 6 most common compliance failures in Part 11 and Annex 11.
  • Master Documentation: Learn how to create precise, compliant documentation that supports data integrity requirements—boosting your efficiency and reducing overhead.
  • Expert-Led Training: Gain invaluable insights from David Nettleton, a recognized leader in Computer System Validation, who will provide practical, hands-on advice.

Whether you’re looking to demystify the validation process, strengthen your compliance, or stay ahead of the regulatory curve, this webinar offers the expert guidance you need.

Join us and take a proactive step toward compliance excellence.

Enroll Now and ensure your team is prepared for 2024-25.

• • Identifying Data and Systems Covered by 21 CFR Part 11 and Annex 11: Understand which systems require compliance and the scope of regulations.
  • The Business Case for Data Integrity Compliance: Learn how maintaining data integrity can drive operational efficiency and regulatory success.
  • Hosting Requirements: Local, SaaS, and Cloud Solutions: Explore compliance requirements for different hosting environments, including local, SaaS, and cloud-based systems.
  • Top 6 Challenges in FDA Software Validation & Verification: Discover the most common validation pitfalls and how to proactively address them.
  • Proactive Strategies to Circumvent Validation and Verification Issues: Gain insights into proven strategies that help avoid validation issues before they arise.
  • Keys to Effective Validation Project Team Assembly: Learn how to build and manage a project team to ensure successful validation outcomes.
  • Strategies to Prevent 483s and Warning Letters: Equip yourself with tactics to avoid costly FDA citations by understanding key compliance factors.
  • Distinguishing Between Software That Requires Validation and That Which Does Not: Clarify when validation is necessary and how to differentiate software types.
  • Insights into GAMP, Qualification, and Validation Processes: Master the processes of GAMP (Good Automated Manufacturing Practice) and software qualification.
  • Deciphering Regulatory Intent Beyond Textual Interpretations: Understand how to interpret and apply regulatory intent beyond the text of the regulations.
  • Navigating Part 11 Compliance: SOPs, Product Features, and Documentation: Ensure your SOPs and product features align with Part 11 compliance requirements.
  • Adhering to Industry Standards for Security, Data Transfer, Audit Trails, and Electronic Signatures: Learn the best practices for maintaining compliance in these critical areas.

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.

• • Identifying Data and Systems Covered by 21 CFR Part 11 and Annex 11: Understand which systems require compliance and the scope of regulations.
  • The Business Case for Data Integrity Compliance: Learn how maintaining data integrity can drive operational efficiency and regulatory success.
  • Hosting Requirements: Local, SaaS, and Cloud Solutions: Explore compliance requirements for different hosting environments, including local, SaaS, and cloud-based systems.
  • Top 6 Challenges in FDA Software Validation & Verification: Discover the most common validation pitfalls and how to proactively address them.
  • Proactive Strategies to Circumvent Validation and Verification Issues: Gain insights into proven strategies that help avoid validation issues before they arise.
  • Keys to Effective Validation Project Team Assembly: Learn how to build and manage a project team to ensure successful validation outcomes.
  • Strategies to Prevent 483s and Warning Letters: Equip yourself with tactics to avoid costly FDA citations by understanding key compliance factors.
  • Distinguishing Between Software That Requires Validation and That Which Does Not: Clarify when validation is necessary and how to differentiate software types.
  • Insights into GAMP, Qualification, and Validation Processes: Master the processes of GAMP (Good Automated Manufacturing Practice) and software qualification.
  • Deciphering Regulatory Intent Beyond Textual Interpretations: Understand how to interpret and apply regulatory intent beyond the text of the regulations.
  • Navigating Part 11 Compliance: SOPs, Product Features, and Documentation: Ensure your SOPs and product features align with Part 11 compliance requirements.
  • Adhering to Industry Standards for Security, Data Transfer, Audit Trails, and Electronic Signatures: Learn the best practices for maintaining compliance in these critical areas.

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 Managers looking to eliminate costly validation mistakes and ensure smooth FDA audits.
  • Regulatory Affairs Specialists aiming to stay ahead of 2024 FDA software validation changes and maintain compliance.
  • IT and Software Validation Engineers focused on mastering GAMP processes and streamlining validation projects for faster approvals.
  • Project Managers overseeing validation teams who need proven strategies to prevent non-compliance issues and avoid 483s.
  • Compliance Officers striving to navigate complex Part 11 regulations and ensure accurate documentation for audits.
  • Training Managers responsible for designing learning paths to equip teams with up-to-date FDA validation knowledge.
  • HR Professionals seeking to improve team efficiency by offering training that addresses common validation and compliance pitfalls.
  • Life Sciences Executives who want to boost operational efficiency and reduce risks by adopting best practices in software validation.
  • Pharmaceutical and Medical Device Leaders needing to ensure data integrity and security while staying compliant with the latest regulatory requirements.

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

• • Quality Assurance Managers looking to eliminate costly validation mistakes and ensure smooth FDA audits.
  • Regulatory Affairs Specialists aiming to stay ahead of 2024 FDA software validation changes and maintain compliance.
  • IT and Software Validation Engineers focused on mastering GAMP processes and streamlining validation projects for faster approvals.
  • Project Managers overseeing validation teams who need proven strategies to prevent non-compliance issues and avoid 483s.
  • Compliance Officers striving to navigate complex Part 11 regulations and ensure accurate documentation for audits.
  • Training Managers responsible for designing learning paths to equip teams with up-to-date FDA validation knowledge.
  • HR Professionals seeking to improve team efficiency by offering training that addresses common validation and compliance pitfalls.
  • Life Sciences Executives who want to boost operational efficiency and reduce risks by adopting best practices in software validation.
  • Pharmaceutical and Medical Device Leaders needing to ensure data integrity and security while staying compliant with the latest regulatory requirements.