Instructor :
David Nettelton

Webinar ID:
2365

Imagine starting your week free from compliance stress and security threats, equipped with the tools to handle them with confidence.

In the digital age, data has become your most valuable—and vulnerable—asset. Ensuring data integrity and privacy isn’t just a daunting challenge; it’s now a business imperative.

For organizations in pharmaceuticals, biotechnology, and medical devices, compliance isn’t just about avoiding fines. It’s about protecting your data, reputation, and integrity. With growing regulatory focus from GDPR, 21 CFR Part 11, and similar standards, data integrity and privacy are no longer optional—they are non-negotiable.

Key Takeaways from This Webinar

This 90-minute session is more than just a webinar—it’s your roadmap to mastering compliance:

• • Demystify the latest updates in Computer Software Assurance and 21 CFR Part 11.
  • Navigate Annex 11 for local and SaaS/Cloud-hosted applications.
  • Learn how to craft a Data Privacy Statement that meets EU GDPR standards.

We’ll cover key elements of compliance, including:

• • Standard Operating Procedures (SOPs): Your blueprint for ensuring compliance.
  • Software Requirements: The critical features for your tech stack.
  • Infrastructure Qualification: Building a solid foundation for data integrity.
  • Validation: The ultimate proof of your compliance readiness.

Led by David Nettleton, a recognized leader in Computer System Validation, this webinar goes beyond simple compliance. Learn how to turn regulatory requirements into strategic advantages, leveraging electronic records and signatures to boost productivity and innovation.

Reserve your seat now and turn compliance challenges into a competitive edge.

Join Now!

Imagine starting your week free from compliance stress and security threats, equipped with the tools to handle them with confidence.

In the digital age, data has become your most valuable—and vulnerable—asset. Ensuring data integrity and privacy isn’t just a daunting challenge; it’s now a business imperative.

For organizations in pharmaceuticals, biotechnology, and medical devices, compliance isn’t just about avoiding fines. It’s about protecting your data, reputation, and integrity. With growing regulatory focus from GDPR, 21 CFR Part 11, and similar standards, data integrity and privacy are no longer optional—they are non-negotiable.

Key Takeaways from This Webinar

This 90-minute session is more than just a webinar—it’s your roadmap to mastering compliance:

• • Demystify the latest updates in Computer Software Assurance and 21 CFR Part 11.
  • Navigate Annex 11 for local and SaaS/Cloud-hosted applications.
  • Learn how to craft a Data Privacy Statement that meets EU GDPR standards.

We’ll cover key elements of compliance, including:

• • Standard Operating Procedures (SOPs): Your blueprint for ensuring compliance.
  • Software Requirements: The critical features for your tech stack.
  • Infrastructure Qualification: Building a solid foundation for data integrity.
  • Validation: The ultimate proof of your compliance readiness.

Led by David Nettleton, a recognized leader in Computer System Validation, this webinar goes beyond simple compliance. Learn how to turn regulatory requirements into strategic advantages, leveraging electronic records and signatures to boost productivity and innovation.

Reserve your seat now and turn compliance challenges into a competitive edge.

Join Now!

Don’t wait for a compliance warning—turn regulatory risks into opportunities for growth.

In today’s highly regulated environment, compliance is more than just a checkbox; it’s a strategic investment.

Avoid costly mistakes by learning from real-world examples and understanding the financial advantages of mastering 21 CFR Part 11, Annex 11, and GDPR compliance.

Key Reasons to Attend:

• • Avoid Costly Compliance Failures: Protect your company by learning from the mistakes of others who received FDA Warning Letters.
  • Maximize ROI with Compliance: Discover how meeting Part 11 and GDPR requirements can provide financial benefits, not just reduce risks.
  • Identify Critical Data and Systems: Know exactly which data and systems fall under the scope of 21 CFR Part 11 and Annex 11 to ensure full compliance.
  • Simplify Complex Standards: Get practical, easy-to-follow insights on security, data transfer, and electronic records management.
  • Master Electronic Approvals: Streamline your processes with efficient electronic approvals and keep pace with industry best practices.
  • Write GDPR-Compliant Data Privacy Statements: Learn how to craft effective, GDPR-compliant Data Privacy Statements that protect both your company and customers.
  • Navigate Cloud and SaaS Compliance: Stay updated on the latest regulations affecting cloud-hosted and SaaS applications.
  • Stay Ahead of the Curve: Understand the industry-standard features you need, including audit trails, e-signatures, and data transfer security.
  • Leverage Electronic Signatures: Ensure the integrity of your data and intellectual property with proper electronic signature practices.

This course provides actionable insights that help you avoid compliance pitfalls, protect your company’s reputation, and ensure success in today’s digital landscape.

Enroll Now to safeguard your business and turn compliance into a competitive advantage!

Register Today!

Don’t wait for a compliance warning—turn regulatory risks into opportunities for growth.

In today’s highly regulated environment, compliance is more than just a checkbox; it’s a strategic investment.

Avoid costly mistakes by learning from real-world examples and understanding the financial advantages of mastering 21 CFR Part 11, Annex 11, and GDPR compliance.

Key Reasons to Attend:

• • Avoid Costly Compliance Failures: Protect your company by learning from the mistakes of others who received FDA Warning Letters.
  • Maximize ROI with Compliance: Discover how meeting Part 11 and GDPR requirements can provide financial benefits, not just reduce risks.
  • Identify Critical Data and Systems: Know exactly which data and systems fall under the scope of 21 CFR Part 11 and Annex 11 to ensure full compliance.
  • Simplify Complex Standards: Get practical, easy-to-follow insights on security, data transfer, and electronic records management.
  • Master Electronic Approvals: Streamline your processes with efficient electronic approvals and keep pace with industry best practices.
  • Write GDPR-Compliant Data Privacy Statements: Learn how to craft effective, GDPR-compliant Data Privacy Statements that protect both your company and customers.
  • Navigate Cloud and SaaS Compliance: Stay updated on the latest regulations affecting cloud-hosted and SaaS applications.
  • Stay Ahead of the Curve: Understand the industry-standard features you need, including audit trails, e-signatures, and data transfer security.
  • Leverage Electronic Signatures: Ensure the integrity of your data and intellectual property with proper electronic signature practices.

This course provides actionable insights that help you avoid compliance pitfalls, protect your company’s reputation, and ensure success in today’s digital landscape.

Enroll Now to safeguard your business and turn compliance into a competitive advantage!

Register Today!

I. Understanding 21 CFR Part 11

• • The Purpose and current interpretation of 21 CFR Part 11
  • Key regulatory requirements and implications for your business

II. Key Compliance Components of Part 11

• • Developing Standard Operating Procedures (SOPs)
  • Essential System Features for regulatory compliance
  • Infrastructure Qualification: Setting up and documenting system qualifications
  • Validation: Ensuring your systems meet regulatory expectations

III. Security Standards

• • Defining Roles and Responsibilities for system users
  • Managing Usernames, Passwords, and access restrictions
  • Maintaining Activity Logs to track user actions

IV. Data Transfer Standards

• • Proper methods for Encrypting Data and ensuring safe transfers
  • Best practices for Deleting Data securely and in compliance with regulations

V. Audit Trail Standards

• • Types of Data that require audit trails
  • Identifying and managing High-Risk Systems

VI. Electronic Approvals and Signatures

• • Implementing Electronic Signatures that meet compliance requirements
  • Single Sign-On (SSO): Streamlining access and approvals
  • Replacing Paper Forms with electronic equivalents to improve efficiency

VII. Infrastructure Qualification

• • Best practices for Documenting Qualifications efficiently

VIII. System Validation

• • Software Validation for vendors and Computer System Validation for users
  • Using Fill-in-the-Blank Templates to streamline validation processes
  • Managing Change Control and Re-Validation efforts

IX. SaaS/Cloud Hosting Compliance

• • Defining Responsibilities for software vendors and hosting providers
  • Establishing Evaluation Criteria and hosting Requirements for compliance

X. Developing Effective SOPs

• • Creating SOPs for IT, QA, and Validation teams
  • Best practices for Software Development under Part 11

XI. Annex 11

• • Comparison with Part 11: Understanding key differences and overlaps

XII. EU GDPR Compliance

• • How to craft a Data Privacy Statement that meets GDPR standards and protects sensitive data

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.

I. Understanding 21 CFR Part 11

• • The Purpose and current interpretation of 21 CFR Part 11
  • Key regulatory requirements and implications for your business

II. Key Compliance Components of Part 11

• • Developing Standard Operating Procedures (SOPs)
  • Essential System Features for regulatory compliance
  • Infrastructure Qualification: Setting up and documenting system qualifications
  • Validation: Ensuring your systems meet regulatory expectations

III. Security Standards

• • Defining Roles and Responsibilities for system users
  • Managing Usernames, Passwords, and access restrictions
  • Maintaining Activity Logs to track user actions

IV. Data Transfer Standards

• • Proper methods for Encrypting Data and ensuring safe transfers
  • Best practices for Deleting Data securely and in compliance with regulations

V. Audit Trail Standards

• • Types of Data that require audit trails
  • Identifying and managing High-Risk Systems

VI. Electronic Approvals and Signatures

• • Implementing Electronic Signatures that meet compliance requirements
  • Single Sign-On (SSO): Streamlining access and approvals
  • Replacing Paper Forms with electronic equivalents to improve efficiency

VII. Infrastructure Qualification

• • Best practices for Documenting Qualifications efficiently

VIII. System Validation

• • Software Validation for vendors and Computer System Validation for users
  • Using Fill-in-the-Blank Templates to streamline validation processes
  • Managing Change Control and Re-Validation efforts

IX. SaaS/Cloud Hosting Compliance

• • Defining Responsibilities for software vendors and hosting providers
  • Establishing Evaluation Criteria and hosting Requirements for compliance

X. Developing Effective SOPs

• • Creating SOPs for IT, QA, and Validation teams
  • Best practices for Software Development under Part 11

XI. Annex 11

• • Comparison with Part 11: Understanding key differences and overlaps

XII. EU GDPR Compliance

• • How to craft a Data Privacy Statement that meets GDPR standards and protects sensitive data

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.

Maximize the Learning Experience in A Group Setting!

• • Quality Assurance Managers looking to ensure compliance with 21 CFR Part 11 and avoid costly regulatory fines.
  • IT Directors tasked with securing systems and managing cloud-hosted/SaaS applications in a compliant manner.
  • Regulatory Affairs Professionals seeking to master the nuances of GDPR and Annex 11 to safeguard data integrity.
  • Compliance Officers aiming to streamline electronic signatures and implement audit trails effectively.
  • Validation Specialists responsible for ensuring the validation of software and computer systems meets regulatory standards.
  • Data Privacy Officers needing to craft GDPR-compliant Data Privacy Statements that protect sensitive customer information.
  • Pharmaceutical & Biotech Leaders wanting to strengthen data integrity and compliance to build trust with regulators.
  • HR and Training Managers looking to provide their teams with actionable knowledge in compliance and regulatory requirements.
  • Software Vendors and Hosting Providers who need to understand their role in maintaining compliance for their customers’ systems.

Maximize the Learning Experience in A Group Setting!

• • Quality Assurance Managers looking to ensure compliance with 21 CFR Part 11 and avoid costly regulatory fines.
  • IT Directors tasked with securing systems and managing cloud-hosted/SaaS applications in a compliant manner.
  • Regulatory Affairs Professionals seeking to master the nuances of GDPR and Annex 11 to safeguard data integrity.
  • Compliance Officers aiming to streamline electronic signatures and implement audit trails effectively.
  • Validation Specialists responsible for ensuring the validation of software and computer systems meets regulatory standards.
  • Data Privacy Officers needing to craft GDPR-compliant Data Privacy Statements that protect sensitive customer information.
  • Pharmaceutical & Biotech Leaders wanting to strengthen data integrity and compliance to build trust with regulators.
  • HR and Training Managers looking to provide their teams with actionable knowledge in compliance and regulatory requirements.
  • Software Vendors and Hosting Providers who need to understand their role in maintaining compliance for their customers’ systems.