Instructor :
David Nettelton

Webinar ID:
3772

As we step into 2025, ensuring your software systems meet FDA validation requirements is not just a regulatory necessity—it’s a business-critical priority. This 2-hour live webinar is your go-to guide to navigating the most pressing compliance challenges with confidence.

With regulatory updates and shifting compliance landscapes, organizations can no longer afford to rely on outdated processes.

This session equips you with practical tools and actionable strategies to avoid costly missteps and maintain audit readiness in the year ahead.

What You’ll Gain

• • Expert Insights: Learn directly from David Nettleton, a renowned authority in Computer System Validation (CSV) and FDA compliance.
  • Regulatory Know-How: Stay current with the latest FDA software validation updates for 2024-25.
  • Compliance Mastery: Deepen your understanding of 21 CFR Part 11, GAMP principles, and core validation processes critical for success.
  • Pitfall Avoidance: Identify and prevent the 6 most common compliance failures that drain time, resources, and revenue.
  • Part 11 Expertise: Gain practical tips for implementing SOPs, audit trails, data security, and electronic signatures to stay audit-ready.

This session is tailored for professionals in quality assurance, regulatory affairs, IT, and validation roles across regulated industries. Whether you’re refining an existing compliance strategy or building one for 2025, this webinar is your blueprint for success.

With increasing regulatory complexity and evolving technologies, software validation is more than a compliance requirement—it’s a strategic business imperative. Equip yourself with the tools to stay compliant, avoid errors, and protect your organization from costly risks.

Don’t wait—secure your spot today!

Register Now and ensure your organization’s compliance strategy is ready for 2025.

As we step into 2025, ensuring your software systems meet FDA validation requirements is not just a regulatory necessity—it’s a business-critical priority. This 2-hour live webinar is your go-to guide to navigating the most pressing compliance challenges with confidence.

With regulatory updates and shifting compliance landscapes, organizations can no longer afford to rely on outdated processes.

This session equips you with practical tools and actionable strategies to avoid costly missteps and maintain audit readiness in the year ahead.

What You’ll Gain

• • Expert Insights: Learn directly from David Nettleton, a renowned authority in Computer System Validation (CSV) and FDA compliance.
  • Regulatory Know-How: Stay current with the latest FDA software validation updates for 2024-25.
  • Compliance Mastery: Deepen your understanding of 21 CFR Part 11, GAMP principles, and core validation processes critical for success.
  • Pitfall Avoidance: Identify and prevent the 6 most common compliance failures that drain time, resources, and revenue.
  • Part 11 Expertise: Gain practical tips for implementing SOPs, audit trails, data security, and electronic signatures to stay audit-ready.

This session is tailored for professionals in quality assurance, regulatory affairs, IT, and validation roles across regulated industries. Whether you’re refining an existing compliance strategy or building one for 2025, this webinar is your blueprint for success.

With increasing regulatory complexity and evolving technologies, software validation is more than a compliance requirement—it’s a strategic business imperative. Equip yourself with the tools to stay compliant, avoid errors, and protect your organization from costly risks.

Don’t wait—secure your spot today!

Register Now and ensure your organization’s compliance strategy is ready for 2025.

Navigating the complex and evolving landscape of FDA software validation is no longer optional—it’s a business-critical priority and a career-enhancing opportunity.

This live webinar is your chance to gain actionable insights and practical tools to meet regulatory demands, avoid compliance failures, and position yourself as a leader in your field.

Studies show that organizations that adapt swiftly to regulatory changes can see significant benefits, including up to a 15% boost in operational efficiency and a marked reduction in compliance risks.

Don’t let outdated practices or knowledge gaps hold you back—equip yourself to thrive in 2025 and beyond.

Key Reasons to Attend

• • Understand Critical Regulatory Shifts: Stay ahead of the latest FDA software validation updates and their implications for your organization in 2024-25.
  • Avoid Costly Mistakes: Learn how to prevent the 6 most common compliance failures that lead to audits, penalties, and inefficiencies.
  • Improve Documentation Practices: Master compliant and efficient documentation techniques that enhance data integrity and simplify audits.
  • Solve Real-World Challenges: Gain proven problem-solving strategies to address 21 CFR Part 11 and Annex 11 compliance hurdles effectively.
  • Learn from an Industry Expert: Receive hands-on guidance from David Nettleton, a recognized leader in Computer System Validation with decades of experience.
  • Boost Your Career: Build in-demand expertise to confidently manage compliance risks, drive efficiency, and advance your professional growth.

With regulatory demands becoming stricter and 2025 already here, staying prepared is essential to maintaining compliance, avoiding disruptions, and ensuring your organization’s success.

Join this webinar to gain the tools and insights needed to excel in the evolving regulatory landscape. Take control of your compliance strategy and secure your career advancement today.

Register Now!

Navigating the complex and evolving landscape of FDA software validation is no longer optional—it’s a business-critical priority and a career-enhancing opportunity.

This live webinar is your chance to gain actionable insights and practical tools to meet regulatory demands, avoid compliance failures, and position yourself as a leader in your field.

Studies show that organizations that adapt swiftly to regulatory changes can see significant benefits, including up to a 15% boost in operational efficiency and a marked reduction in compliance risks.

Don’t let outdated practices or knowledge gaps hold you back—equip yourself to thrive in 2025 and beyond.

Key Reasons to Attend

• • Understand Critical Regulatory Shifts: Stay ahead of the latest FDA software validation updates and their implications for your organization in 2024-25.
  • Avoid Costly Mistakes: Learn how to prevent the 6 most common compliance failures that lead to audits, penalties, and inefficiencies.
  • Improve Documentation Practices: Master compliant and efficient documentation techniques that enhance data integrity and simplify audits.
  • Solve Real-World Challenges: Gain proven problem-solving strategies to address 21 CFR Part 11 and Annex 11 compliance hurdles effectively.
  • Learn from an Industry Expert: Receive hands-on guidance from David Nettleton, a recognized leader in Computer System Validation with decades of experience.
  • Boost Your Career: Build in-demand expertise to confidently manage compliance risks, drive efficiency, and advance your professional growth.

With regulatory demands becoming stricter and 2025 already here, staying prepared is essential to maintaining compliance, avoiding disruptions, and ensuring your organization’s success.

Join this webinar to gain the tools and insights needed to excel in the evolving regulatory landscape. Take control of your compliance strategy and secure your career advancement today.

Register Now!

• • 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.