Instructor :
David Nettelton

Webinar ID:
11163

Are regulations like 21 CFR Part 11 and EU GDPR impacting your daily operations?
Struggling with data integrity and rising compliance costs?

These challenges are now more prevalent than ever.

Join David Nettleton, a renowned FDA Compliance Specialist in Computer System Validation, for a comprehensive two-day webinar on strategies to reduce compliance costs associated with data integrity.

This course covers crucial regulations, including 21 CFR Part 11, SaaS/Cloud solutions, and the EU GDPR, providing real-life examples and practical approaches to optimize compliance operations.

Key Topics Covered:

• • 21 CFR Part 11 and Annex 11 Compliance: In-depth exploration of SOPs, software features, infrastructure qualification, and validation requirements.
  • Latest Industry Standards: Learn about data security, data transfer, audit trails, electronic records and signatures, and validation.
  • Cloud Solutions: Understand specific requirements for local and SaaS/cloud hosting to enhance data integrity and security.
  • Risk-Based Validation Approach: Apply a 10-step risk-based method to computer system validation, reducing implementation times and costs.
  • FDA Inspection Trends: Discover recent inspection trends and strategies to streamline documentation, avoiding common pitfalls like 483s and Warning Letters.
  • Data Privacy Compliance: Learn to write effective Data Privacy Statements to meet EU GDPR requirements.

Learning Objectives:

• • Cost Reduction: Achieve up to two-thirds reduction in compliance costs for electronic records.
  • Efficiency with E-Records and E-Signatures: Maximize productivity and ensure compliance.
  • Inspection Preparation: Get ready for Part 11 and Annex 11 inspections with a solid understanding of their dynamics.
  • Risk Management: Master risk-based Computer System Validation with easy-to-apply templates.
  • Streamlined Change Control: Implement “right-size” change control methods for quick and safe system evolution.
  • Documentation and Testing: Minimize validation documentation and testing time while managing risks.
  • Vendor Management: Learn how to purchase COTS software and qualify vendors to safeguard intellectual property and secure electronic records.

Equip your team with the knowledge to implement cost-effective, compliant computer systems.

Secure your spot today for this expert-led training that combines theoretical knowledge with practical applications.

Join Now!

Are regulations like 21 CFR Part 11 and EU GDPR impacting your daily operations?
Struggling with data integrity and rising compliance costs?

These challenges are now more prevalent than ever.

Join David Nettleton, a renowned FDA Compliance Specialist in Computer System Validation, for a comprehensive two-day webinar on strategies to reduce compliance costs associated with data integrity.

This course covers crucial regulations, including 21 CFR Part 11, SaaS/Cloud solutions, and the EU GDPR, providing real-life examples and practical approaches to optimize compliance operations.

Key Topics Covered:

• • 21 CFR Part 11 and Annex 11 Compliance: In-depth exploration of SOPs, software features, infrastructure qualification, and validation requirements.
  • Latest Industry Standards: Learn about data security, data transfer, audit trails, electronic records and signatures, and validation.
  • Cloud Solutions: Understand specific requirements for local and SaaS/cloud hosting to enhance data integrity and security.
  • Risk-Based Validation Approach: Apply a 10-step risk-based method to computer system validation, reducing implementation times and costs.
  • FDA Inspection Trends: Discover recent inspection trends and strategies to streamline documentation, avoiding common pitfalls like 483s and Warning Letters.
  • Data Privacy Compliance: Learn to write effective Data Privacy Statements to meet EU GDPR requirements.

Learning Objectives:

• • Cost Reduction: Achieve up to two-thirds reduction in compliance costs for electronic records.
  • Efficiency with E-Records and E-Signatures: Maximize productivity and ensure compliance.
  • Inspection Preparation: Get ready for Part 11 and Annex 11 inspections with a solid understanding of their dynamics.
  • Risk Management: Master risk-based Computer System Validation with easy-to-apply templates.
  • Streamlined Change Control: Implement “right-size” change control methods for quick and safe system evolution.
  • Documentation and Testing: Minimize validation documentation and testing time while managing risks.
  • Vendor Management: Learn how to purchase COTS software and qualify vendors to safeguard intellectual property and secure electronic records.

Equip your team with the knowledge to implement cost-effective, compliant computer systems.

Secure your spot today for this expert-led training that combines theoretical knowledge with practical applications.

Join Now!

In today’s highly regulated and cost-conscious environment, streamlining compliance while maintaining data integrity is more crucial than ever.

This bootcamp, led by FDA Compliance Specialist David Nettleton, is designed to empower you with the strategies, tools, and insights necessary to achieve these goals effectively.

Why Attend?

• • Stay Ahead of Regulations: With evolving standards like 21 CFR Part 11 and the EU GDPR, understanding specific requirements and compliance pathways is vital. This training ensures you stay up-to-date with the latest industry practices and regulatory expectations.
  • Reduce Operational Costs: Discover proven techniques to cut compliance costs by up to two-thirds. Learn how to implement these strategies through risk-based approaches and efficient use of technology, significantly lowering your organization’s expenses.
  • Enhance Data Security: In an era of frequent data breaches, ensuring the integrity and security of electronic records is paramount. Gain insights into protecting intellectual property and securing sensitive information against threats, safeguarding your organization’s data.
  • Practical Application: Benefit from real-life case studies and interactive workshops that provide hands-on experience in writing requirements, conducting risk assessments, and streamlining documentation processes. Acquire skills that you can immediately apply to your role for enhanced performance.

Attending this webinar will equip you with the knowledge and skills to navigate the complexities of compliance and validation, making you an invaluable asset to your organization.

Don’t miss this opportunity to transform your approach to compliance and enhance your professional value.

Enroll Now!

In today’s highly regulated and cost-conscious environment, streamlining compliance while maintaining data integrity is more crucial than ever.

This bootcamp, led by FDA Compliance Specialist David Nettleton, is designed to empower you with the strategies, tools, and insights necessary to achieve these goals effectively.

Why Attend?

• • Stay Ahead of Regulations: With evolving standards like 21 CFR Part 11 and the EU GDPR, understanding specific requirements and compliance pathways is vital. This training ensures you stay up-to-date with the latest industry practices and regulatory expectations.
  • Reduce Operational Costs: Discover proven techniques to cut compliance costs by up to two-thirds. Learn how to implement these strategies through risk-based approaches and efficient use of technology, significantly lowering your organization’s expenses.
  • Enhance Data Security: In an era of frequent data breaches, ensuring the integrity and security of electronic records is paramount. Gain insights into protecting intellectual property and securing sensitive information against threats, safeguarding your organization’s data.
  • Practical Application: Benefit from real-life case studies and interactive workshops that provide hands-on experience in writing requirements, conducting risk assessments, and streamlining documentation processes. Acquire skills that you can immediately apply to your role for enhanced performance.

Attending this webinar will equip you with the knowledge and skills to navigate the complexities of compliance and validation, making you an invaluable asset to your organization.

Don’t miss this opportunity to transform your approach to compliance and enhance your professional value.

Enroll Now!

Day 1 Agenda: 6 Hours

1. Introduction to the FDA
   • Understanding FDA Regulations: How regulations enhance your company’s success.
   • Scope of Part 11: Identifying which data and systems are subject to Part 11.
2. 21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures
   • Interpreting Part 11: What Part 11 means for you beyond the written regulations.
   • Preventing Non-Compliance: Strategies to avoid 483s and Warning Letters.
   • Primary Areas of Part 11 Compliance: Dive into SOPs, software product features, infrastructure qualification, and validation documentation.
   • Impact of SaaS/Cloud on Compliance: How cloud computing alters qualification and validation processes.
   • Securing Data and Intellectual Property: Ensuring data integrity and protecting intellectual property.
   • Industry Standards for System Security: Current standards for security, data transfer, and audit trails.
   • Advanced Electronic Signatures: Explore the use of electronic signatures, digital pens, and biometric signatures.
   • IT Infrastructure SOPs: Essential SOPs for IT infrastructure management.
   • Evaluating COTS Software Features: Key product features to consider when purchasing.
   • Streamlining Validation Documentation: Utilizing easy-to-understand, fill-in-the-blank validation documents to reduce resource use.
3. The Five Keys to COTS Computer System Validation
   • Essentials of CSV: Understanding the Who, What, Where, When, and Why of Computer System Validation.
4. The Validation Team
   • Team Selection: How to select effective team members for validation projects.
   • Project Facilitation: Best practices for managing and facilitating validation projects.
5. Ten-Step Process for COTS Risk-Based Computer System Validation
   • Introduction to Risk-Based CSV: Laying the groundwork for a detailed exploration on Day 2.

Day 2 Agenda: 6 Hours

Day 2 builds upon the foundations set on Day 1, focusing on practical applications, advanced validation techniques, and strategic compliance practices, culminating in a comprehensive understanding of cost-efficient compliance strategies.

1. Software Demonstrations and Discussions (30 Min)
   • Interactive Session: Engage in practical demonstrations and discussions on software applications.
2. Continuation of Ten-Step Process for COTS Risk-Based Computer System Validation (30 Min)
   • FDA Documentation Expectations: Learn about the documents the FDA expects to audit.
   • Cost-Effective Validation: Applying a risk-based validation approach to lower costs.
   • Linking Validation Components: How to connect requirements, specifications, risk management, and testing.
   • Practical Documentation: Use fill-in-the-blank templates to document validation projects effectively.
   • Foundational Resource: Based on “Risk-Based Software Validation – Ten Easy Steps” (Davis Horwood International and PDA, 2006).
3. Writing Requirements and Specifications Workshop (30 Min)
   • Developing Specifications: Workshop on how to write requirements and expand them into detailed specifications.
4. Hazard Analysis/Risk Assessment Exercise (30 Min)
   • Step-by-Step Risk Assessment: Instructions on performing and documenting a risk assessment to streamline validation documentation.
5. Software Testing (30 Min)
   • Efficient Testing Methods: Strategies to reduce testing time by writing test cases linked to risk management elements.
   • Writing Test Cases: Tips on crafting effective and efficient test cases.
6. Data Privacy Compliance (30 Min)
   • Writing a Data Privacy Statement: Guidelines on complying with the EU General Data Protection Regulation (GDPR).
7. Purchasing COTS Software (30 Min)
   • Evaluating Software Vendors: Best practices for purchasing COTS software and assessing vendors.
8. Cost Reduction Strategies (45 Min)
   • Economical Compliance: Strategies to save money while maintaining or increasing quality and compliance.
   • Optimizing Documentation: Learn how to achieve more with less documentation, minimizing regulatory and business risks.

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.

Day 1 Agenda: 6 Hours

1. Introduction to the FDA
   • Understanding FDA Regulations: How regulations enhance your company’s success.
   • Scope of Part 11: Identifying which data and systems are subject to Part 11.
2. 21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures
   • Interpreting Part 11: What Part 11 means for you beyond the written regulations.
   • Preventing Non-Compliance: Strategies to avoid 483s and Warning Letters.
   • Primary Areas of Part 11 Compliance: Dive into SOPs, software product features, infrastructure qualification, and validation documentation.
   • Impact of SaaS/Cloud on Compliance: How cloud computing alters qualification and validation processes.
   • Securing Data and Intellectual Property: Ensuring data integrity and protecting intellectual property.
   • Industry Standards for System Security: Current standards for security, data transfer, and audit trails.
   • Advanced Electronic Signatures: Explore the use of electronic signatures, digital pens, and biometric signatures.
   • IT Infrastructure SOPs: Essential SOPs for IT infrastructure management.
   • Evaluating COTS Software Features: Key product features to consider when purchasing.
   • Streamlining Validation Documentation: Utilizing easy-to-understand, fill-in-the-blank validation documents to reduce resource use.
3. The Five Keys to COTS Computer System Validation
   • Essentials of CSV: Understanding the Who, What, Where, When, and Why of Computer System Validation.
4. The Validation Team
   • Team Selection: How to select effective team members for validation projects.
   • Project Facilitation: Best practices for managing and facilitating validation projects.
5. Ten-Step Process for COTS Risk-Based Computer System Validation
   • Introduction to Risk-Based CSV: Laying the groundwork for a detailed exploration on Day 2.

Day 2 Agenda: 6 Hours

Day 2 builds upon the foundations set on Day 1, focusing on practical applications, advanced validation techniques, and strategic compliance practices, culminating in a comprehensive understanding of cost-efficient compliance strategies.

1. Software Demonstrations and Discussions (30 Min)
   • Interactive Session: Engage in practical demonstrations and discussions on software applications.
2. Continuation of Ten-Step Process for COTS Risk-Based Computer System Validation (30 Min)
   • FDA Documentation Expectations: Learn about the documents the FDA expects to audit.
   • Cost-Effective Validation: Applying a risk-based validation approach to lower costs.
   • Linking Validation Components: How to connect requirements, specifications, risk management, and testing.
   • Practical Documentation: Use fill-in-the-blank templates to document validation projects effectively.
   • Foundational Resource: Based on “Risk-Based Software Validation – Ten Easy Steps” (Davis Horwood International and PDA, 2006).
3. Writing Requirements and Specifications Workshop (30 Min)
   • Developing Specifications: Workshop on how to write requirements and expand them into detailed specifications.
4. Hazard Analysis/Risk Assessment Exercise (30 Min)
   • Step-by-Step Risk Assessment: Instructions on performing and documenting a risk assessment to streamline validation documentation.
5. Software Testing (30 Min)
   • Efficient Testing Methods: Strategies to reduce testing time by writing test cases linked to risk management elements.
   • Writing Test Cases: Tips on crafting effective and efficient test cases.
6. Data Privacy Compliance (30 Min)
   • Writing a Data Privacy Statement: Guidelines on complying with the EU General Data Protection Regulation (GDPR).
7. Purchasing COTS Software (30 Min)
   • Evaluating Software Vendors: Best practices for purchasing COTS software and assessing vendors.
8. Cost Reduction Strategies (45 Min)
   • Economical Compliance: Strategies to save money while maintaining or increasing quality and compliance.
   • Optimizing Documentation: Learn how to achieve more with less documentation, minimizing regulatory and business risks.

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!

This webinar is ideal for professionals in the healthcare, clinical trials, biopharmaceutical, and medical device industries, particularly those who utilize computer systems in their day-to-day job functions. It is crucial for software vendors, auditors, and quality staff involved in GxP applications.

• System owners – responsible for keeping individual systems in validation
• Computer system users
• QA / QC managers, executives and personnel
• IT / IS managers and personnel
• Validation specialists
• Laboratory staff
• Managers
• GMP, GCP, GLP professionals

Maximize the Learning Experience in A Group Setting!

This bootcamp is ideal for professionals in the healthcare, clinical trials, biopharmaceutical, and medical device industries, particularly those who utilize computer systems in their day-to-day job functions. It is crucial for software vendors, auditors, and quality staff involved in GxP applications.

• System owners – responsible for keeping individual systems in validation
• Computer system users
• QA / QC managers, executives and personnel
• IT / IS managers and personnel
• Validation specialists
• Laboratory staff
• Managers
• GMP, GCP, GLP professionals