Instructor :
Meredith Crabtree

Webinar ID:
12175

In regulated industries, change control is critical to maintaining compliance, product quality, and operational efficiency. But managing changes to processes, equipment, or materials can often feel like walking a compliance tightrope.

This webinar is designed to help you streamline change control processes while ensuring that every regulatory impact is fully assessed.

By focusing on practical strategies and aligning with FDA and ISO standards, you’ll learn how to minimize compliance risks and avoid costly errors.

Participants will walk away with:

• • Expert insights on implementing effective change control systems
  • Best practices for conducting comprehensive regulatory impact assessments
  • Strategies for aligning your change management with FDA and ISO requirements
  • Techniques to improve efficiency while maintaining full compliance

Key Takeaways:

• • Ensure compliance with well-documented and thoroughly assessed changes
  • Avoid penalties and reduce risk with proven change control methodologies
  • Improve efficiency without sacrificing regulatory alignment

Whether you’re responsible for compliance, quality assurance, or risk management, this webinar will provide you with the tools to navigate complex regulatory landscapes while keeping your operations running smoothly.

Enroll Now!

In regulated industries, change control is critical to maintaining compliance, product quality, and operational efficiency. But managing changes to processes, equipment, or materials can often feel like walking a compliance tightrope.

This webinar is designed to help you streamline change control processes while ensuring that every regulatory impact is fully assessed.

By focusing on practical strategies and aligning with FDA and ISO standards, you’ll learn how to minimize compliance risks and avoid costly errors.

Participants will walk away with:

• • Expert insights on implementing effective change control systems
  • Best practices for conducting comprehensive regulatory impact assessments
  • Strategies for aligning your change management with FDA and ISO requirements
  • Techniques to improve efficiency while maintaining full compliance

Key Takeaways:

• • Ensure compliance with well-documented and thoroughly assessed changes
  • Avoid penalties and reduce risk with proven change control methodologies
  • Improve efficiency without sacrificing regulatory alignment

Whether you’re responsible for compliance, quality assurance, or risk management, this webinar will provide you with the tools to navigate complex regulatory landscapes while keeping your operations running smoothly.

Enroll Now!

Managing change effectively is crucial to maintaining compliance, minimizing risk, and driving operational efficiency.

This training offers actionable insights to help you overcome common compliance challenges while improving your organization’s agility and performance.

If you’re looking to stay ahead of evolving regulations, streamline your change processes, and enhance your career, this webinar is for you.

By attending, you will:

• • Understand the Principles of Change Control: Gain a clear grasp of how change control directly impacts compliance and product quality in regulated industries.
  • Implement Effective Change Control Systems: Learn to design structured systems with defined roles and responsibilities, ensuring accountability and consistency across your organization.
  • Conduct Thorough Regulatory Impact Assessments: Master the skills to evaluate changes for compliance risks, and develop effective mitigation strategies to avoid penalties.
  • Align with FDA and ISO Standards: Ensure your change management practices meet the latest regulatory expectations by aligning with FDA and ISO standards.
  • Apply Best Practices from Real-World Case Studies: Analyze successful (and not-so-successful) case studies, and discover how to implement industry-leading change control and regulatory assessment practices.
  • Foster a Culture of Compliance: Learn strategies to build a strong culture of compliance, where continuous improvement and employee engagement are at the heart of every change process.

This training is essential for professionals in compliance, quality assurance, and risk management who want to advance their skills and lead their organizations with confidence through the complexities of regulatory changes.

Join Now!

Managing change effectively is crucial to maintaining compliance, minimizing risk, and driving operational efficiency.

This training offers actionable insights to help you overcome common compliance challenges while improving your organization’s agility and performance.

If you’re looking to stay ahead of evolving regulations, streamline your change processes, and enhance your career, this webinar is for you.

By attending, you will:

• • Understand the Principles of Change Control: Gain a clear grasp of how change control directly impacts compliance and product quality in regulated industries.
  • Implement Effective Change Control Systems: Learn to design structured systems with defined roles and responsibilities, ensuring accountability and consistency across your organization.
  • Conduct Thorough Regulatory Impact Assessments: Master the skills to evaluate changes for compliance risks, and develop effective mitigation strategies to avoid penalties.
  • Align with FDA and ISO Standards: Ensure your change management practices meet the latest regulatory expectations by aligning with FDA and ISO standards.
  • Apply Best Practices from Real-World Case Studies: Analyze successful (and not-so-successful) case studies, and discover how to implement industry-leading change control and regulatory assessment practices.
  • Foster a Culture of Compliance: Learn strategies to build a strong culture of compliance, where continuous improvement and employee engagement are at the heart of every change process.

This training is essential for professionals in compliance, quality assurance, and risk management who want to advance their skills and lead their organizations with confidence through the complexities of regulatory changes.

Join Now!

1. Introduction to Change Control
   • Definition and importance of change control in regulated industries.
   • Overview of common types of changes (process, equipment, materials) and their impact.
2. Building an Effective Change Control System
   • Key elements of a robust system: documentation, approval processes, and communication protocols.
   • Clearly defined roles and responsibilities within the change control process.
3. Conducting a Regulatory Impact Assessment
   • Step-by-step guide to conducting a thorough regulatory impact assessment.
   • Tools and methodologies for evaluating compliance risks associated with changes.
4. Aligning with FDA and ISO Standards
   • In-depth look at FDA and ISO regulations relevant to change control.
   • Best practices for ensuring regulatory compliance during the change management process.
5. Documentation and Record-Keeping Best Practices
   • The critical role of documentation in change control systems.
   • How to maintain accurate records and ensure the traceability of all changes.
6. Case Studies and Lessons Learned
   • Real-world examples of successful change control implementations and regulatory assessments.
   • Discussion of common challenges and solutions implemented across various industries.
7. Fostering Continuous Improvement and a Culture of Compliance
   • Strategies for promoting a proactive culture of compliance within your organization.
   • Techniques to engage employees and ensure continuous improvement in change control processes.

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.

1. Introduction to Change Control
   • Definition and importance of change control in regulated industries.
   • Overview of common types of changes (process, equipment, materials) and their impact.
2. Building an Effective Change Control System
   • Key elements of a robust system: documentation, approval processes, and communication protocols.
   • Clearly defined roles and responsibilities within the change control process.
3. Conducting a Regulatory Impact Assessment
   • Step-by-step guide to conducting a thorough regulatory impact assessment.
   • Tools and methodologies for evaluating compliance risks associated with changes.
4. Aligning with FDA and ISO Standards
   • In-depth look at FDA and ISO regulations relevant to change control.
   • Best practices for ensuring regulatory compliance during the change management process.
5. Documentation and Record-Keeping Best Practices
   • The critical role of documentation in change control systems.
   • How to maintain accurate records and ensure the traceability of all changes.
6. Case Studies and Lessons Learned
   • Real-world examples of successful change control implementations and regulatory assessments.
   • Discussion of common challenges and solutions implemented across various industries.
7. Fostering Continuous Improvement and a Culture of Compliance
   • Strategies for promoting a proactive culture of compliance within your organization.
   • Techniques to engage employees and ensure continuous improvement in change control processes.

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!

• • Compliance Officers Seeking to Minimize Risk by mastering change control and ensuring regulatory alignment.
  • Quality Assurance Managers Focused on Streamlining Processes while maintaining product quality and avoiding compliance pitfalls.
  • Regulatory Affairs Specialists Looking to Stay Ahead of Evolving Standards and conduct thorough impact assessments to ensure compliance.
  • Operations Managers Aiming to Increase Efficiency by implementing structured change control systems across their teams.
  • Risk Management Professionals Needing to Reduce Compliance Penalties through effective documentation and proactive change management strategies.
  • Department Heads Wanting to Enhance Accountability by assigning clear roles and responsibilities within the change control process.
  • HR Professionals Focused on Building a Culture of Compliance through continuous improvement and employee engagement in regulated environments.
  • Training and Development Leaders Designing Learning Paths to ensure their teams stay compliant with FDA and ISO standards.
  • Consultants Who Advise on Compliance Strategies and want to provide clients with best practices in regulatory change control.

Everybody Benefits from Watching This. Even Better When Done as a Group!

• • Compliance Officers Seeking to Minimize Risk by mastering change control and ensuring regulatory alignment.
  • Quality Assurance Managers Focused on Streamlining Processes while maintaining product quality and avoiding compliance pitfalls.
  • Regulatory Affairs Specialists Looking to Stay Ahead of Evolving Standards and conduct thorough impact assessments to ensure compliance.
  • Operations Managers Aiming to Increase Efficiency by implementing structured change control systems across their teams.
  • Risk Management Professionals Needing to Reduce Compliance Penalties through effective documentation and proactive change management strategies.
  • Department Heads Wanting to Enhance Accountability by assigning clear roles and responsibilities within the change control process.
  • HR Professionals Focused on Building a Culture of Compliance through continuous improvement and employee engagement in regulated environments.
  • Training and Development Leaders Designing Learning Paths to ensure their teams stay compliant with FDA and ISO standards.
  • Consultants Who Advise on Compliance Strategies and want to provide clients with best practices in regulatory change control.