Instructor :
Jose Mora

Webinar ID:
12147

• Are you overwhelmed by the complexities of managing Quality Management Systems (QMS) in a medical device manufacturing environment?
• Struggling to maintain controlled documents and records while ensuring compliance with 21 CFR Part 820?

This 90-minute webinar provides a fresh, simplified approach to managing compliance using Lean Document and Lean Configuration principles. You’ll learn how to streamline your processes, eliminate unnecessary documentation, and maximize the benefits of automation—all while maintaining strict adherence to regulatory requirements.

Key Benefits:

• • Simplify complex document management by applying Lean principles to your QMS.
  • Reduce redundant, repetitive, and clustered documentation that slows down your operations.
  • Free up design and manufacturing resources to focus on innovation rather than paperwork.
  • Ensure every step of your manufacturing process is controlled and documented efficiently, without the chaos of outdated legacy systems.

What You’ll Learn:

• • How to apply the Theory of Lean Documents to minimize the burden of excessive documentation.
  • The Theory of Lean Configuration and how it can revolutionize the way you manage controlled records.
  • Practical solutions to overcome the limitations of legacy document management systems in your QMS.
  • Proven strategies for implementing automated systems that make compliance easier and more efficient.

Why This Matters: Most life sciences businesses—especially in the medical device industry—still rely on outdated, convoluted document systems that create inefficiencies and compliance risks. In many cases, automation systems are underutilized because they are constrained by old, manual methods.

This webinar will show you how to break free from legacy systems and fully realize the benefits of modern information retrieval tools, all while staying compliant with 21 CFR Part 820.

Who Should Attend:

• • Quality managers, engineers, and professionals responsible for regulatory compliance in the life sciences.
  • Medical device manufacturers looking to streamline their QMS processes.
  • Design and manufacturing managers who want to reduce time spent on documentation and increase efficiency.

Join us to discover practical, Lean-based solutions for navigating the challenges of 21 CFR Part 820 with less complexity and more control.

Enroll Now!

• Are you overwhelmed by the complexities of managing Quality Management Systems (QMS) in a medical device manufacturing environment?
• Struggling to maintain controlled documents and records while ensuring compliance with 21 CFR Part 820?

This 90-minute webinar provides a fresh, simplified approach to managing compliance using Lean Document and Lean Configuration principles. You’ll learn how to streamline your processes, eliminate unnecessary documentation, and maximize the benefits of automation—all while maintaining strict adherence to regulatory requirements.

Key Benefits:

• • Simplify complex document management by applying Lean principles to your QMS.
  • Reduce redundant, repetitive, and clustered documentation that slows down your operations.
  • Free up design and manufacturing resources to focus on innovation rather than paperwork.
  • Ensure every step of your manufacturing process is controlled and documented efficiently, without the chaos of outdated legacy systems.

What You’ll Learn:

• • How to apply the Theory of Lean Documents to minimize the burden of excessive documentation.
  • The Theory of Lean Configuration and how it can revolutionize the way you manage controlled records.
  • Practical solutions to overcome the limitations of legacy document management systems in your QMS.
  • Proven strategies for implementing automated systems that make compliance easier and more efficient.

Why This Matters: Most life sciences businesses—especially in the medical device industry—still rely on outdated, convoluted document systems that create inefficiencies and compliance risks. In many cases, automation systems are underutilized because they are constrained by old, manual methods.

This webinar will show you how to break free from legacy systems and fully realize the benefits of modern information retrieval tools, all while staying compliant with 21 CFR Part 820.

Who Should Attend:

• • Quality managers, engineers, and professionals responsible for regulatory compliance in the life sciences.
  • Medical device manufacturers looking to streamline their QMS processes.
  • Design and manufacturing managers who want to reduce time spent on documentation and increase efficiency.

Join us to discover practical, Lean-based solutions for navigating the challenges of 21 CFR Part 820 with less complexity and more control.

Enroll Now!

Staying compliant with 21 CFR Part 820 is not just a legal obligation—it’s critical for maintaining the integrity of your Quality Management System (QMS).

However, many companies are bogged down by outdated, convoluted documentation systems that slow down processes and create unnecessary complexity.

This webinar offers a fresh approach to overcoming these challenges. By applying the Theory of Lean Documents and Lean Configuration, you’ll learn how to streamline your QMS and reduce redundant and excessive documentation.

This isn’t just about saving time—it’s about freeing up your design and manufacturing teams to focus on what they do best: innovation and production.

Here’s why attending this training will benefit you:

• • Simplify Your Compliance: Learn how to effectively apply Lean principles to minimize documentation burdens while maintaining compliance with 21 CFR Part 820.
  • Maximize Efficiency: Discover strategies that will allow your team to spend less time on paperwork and more time on high-value activities like design and manufacturing.
  • Break Free from Legacy Systems: Learn how to eliminate the constraints of outdated document management methods and fully leverage modern automation systems.
  • Stay Competitive: By streamlining your processes, you’ll position your organization for greater efficiency and reduced compliance risk, giving you a competitive edge in the market.

This training provides actionable insights and proven strategies that you can implement immediately to address the real challenges of managing a compliant QMS. Don’t miss the opportunity to revolutionize how your organization approaches compliance and document control.

Join Now!

Staying compliant with 21 CFR Part 820 is not just a legal obligation—it’s critical for maintaining the integrity of your Quality Management System (QMS).

However, many companies are bogged down by outdated, convoluted documentation systems that slow down processes and create unnecessary complexity.

This webinar offers a fresh approach to overcoming these challenges. By applying the Theory of Lean Documents and Lean Configuration, you’ll learn how to streamline your QMS and reduce redundant and excessive documentation.

This isn’t just about saving time—it’s about freeing up your design and manufacturing teams to focus on what they do best: innovation and production.

Here’s why attending this training will benefit you:

• • Simplify Your Compliance: Learn how to effectively apply Lean principles to minimize documentation burdens while maintaining compliance with 21 CFR Part 820.
  • Maximize Efficiency: Discover strategies that will allow your team to spend less time on paperwork and more time on high-value activities like design and manufacturing.
  • Break Free from Legacy Systems: Learn how to eliminate the constraints of outdated document management methods and fully leverage modern automation systems.
  • Stay Competitive: By streamlining your processes, you’ll position your organization for greater efficiency and reduced compliance risk, giving you a competitive edge in the market.

This training provides actionable insights and proven strategies that you can implement immediately to address the real challenges of managing a compliant QMS. Don’t miss the opportunity to revolutionize how your organization approaches compliance and document control.

Join Now!

• • Introduction to Lean Documents and Lean Configuration
    Gain a foundational understanding of Lean principles and how they apply to document management in the context of 21 CFR Part 820. Learn the benefits of streamlining your Quality Management System (QMS) through these approaches.
  • Overview of Quality System Regulation (21 CFR Part 820) and ISO 13485
    Explore the regulatory requirements outlined in 21 CFR Part 820 and ISO 13485 as they apply to design control documents. Understand how these standards influence compliance for medical device manufacturing.
  • Core Functions of Life Sciences Manufacturing Plants
    Get an overview of the essential operations within a life sciences manufacturing environment, including how these functions rely on controlled documentation to maintain compliance and efficiency.
  • Key Types of Controlled Documents and Records
    Learn about the various controlled documents—such as work instructions, SOPs, and equipment maintenance records—required to support manufacturing processes and compliance with regulatory standards.
  • Quality Management System (QMS) Elements Controlled by Documentation
    Understand the critical elements of a QMS that are controlled via documentation, and how Lean principles can help optimize these processes to reduce redundancy and improve workflow efficiency.
  • Bringing It All Together: Practical Application of Lean Principles
    Discover how to integrate Lean Documents and Lean Configuration into your existing QMS to achieve greater efficiency and simplified compliance with 21 CFR Part 820, ensuring a more streamlined and productive operation.

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.

• • Introduction to Lean Documents and Lean Configuration
    Gain a foundational understanding of Lean principles and how they apply to document management in the context of 21 CFR Part 820. Learn the benefits of streamlining your Quality Management System (QMS) through these approaches.
  • Overview of Quality System Regulation (21 CFR Part 820) and ISO 13485
    Explore the regulatory requirements outlined in 21 CFR Part 820 and ISO 13485 as they apply to design control documents. Understand how these standards influence compliance for medical device manufacturing.
  • Core Functions of Life Sciences Manufacturing Plants
    Get an overview of the essential operations within a life sciences manufacturing environment, including how these functions rely on controlled documentation to maintain compliance and efficiency.
  • Key Types of Controlled Documents and Records
    Learn about the various controlled documents—such as work instructions, SOPs, and equipment maintenance records—required to support manufacturing processes and compliance with regulatory standards.
  • Quality Management System (QMS) Elements Controlled by Documentation
    Understand the critical elements of a QMS that are controlled via documentation, and how Lean principles can help optimize these processes to reduce redundancy and improve workflow efficiency.
  • Bringing It All Together: Practical Application of Lean Principles
    Discover how to integrate Lean Documents and Lean Configuration into your existing QMS to achieve greater efficiency and simplified compliance with 21 CFR Part 820, ensuring a more streamlined and productive operation.

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 Managers Struggling with Excessive Documentation
    Learn how to streamline documentation processes and eliminate redundant paperwork in compliance with 21 CFR Part 820.
  • Regulatory Affairs Professionals Seeking Simplified Compliance Strategies
    Discover practical Lean principles to ensure your organization stays compliant without being overwhelmed by complex regulations.
  • Manufacturing Leaders Aiming to Improve Operational Efficiency
    Free your teams from document-heavy tasks so they can focus on innovation and production while maintaining compliance.
  • Process Improvement Specialists Looking to Minimize Waste in QMS
    Learn to apply Lean principles to your Quality Management System for more efficient and effective document control.
  • Medical Device Engineers Wanting to Spend Less Time on Documentation
    Explore ways to reduce the burden of documentation and focus more on design and manufacturing activities.
  • Compliance Officers Concerned About Legacy Document Systems
    Understand how to transition from outdated manual systems to modern, automated solutions that enhance compliance.
  • Operations Managers Focused on Reducing Compliance-Related Delays
    Implement strategies to streamline workflows and reduce delays caused by complex document control systems.
  • IT Professionals Managing Document Control Software for Regulatory Compliance
    Learn how to optimize automation tools and fully leverage your document management systems to support compliance.
  • Executive Leaders Looking to Ensure Company-Wide Regulatory Alignment
    Gain insights on how to simplify compliance and boost efficiency across departments, ensuring adherence to 21 CFR Part 820.

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

• • Quality Managers Struggling with Excessive Documentation
    Learn how to streamline documentation processes and eliminate redundant paperwork in compliance with 21 CFR Part 820.
  • Regulatory Affairs Professionals Seeking Simplified Compliance Strategies
    Discover practical Lean principles to ensure your organization stays compliant without being overwhelmed by complex regulations.
  • Manufacturing Leaders Aiming to Improve Operational Efficiency
    Free your teams from document-heavy tasks so they can focus on innovation and production while maintaining compliance.
  • Process Improvement Specialists Looking to Minimize Waste in QMS
    Learn to apply Lean principles to your Quality Management System for more efficient and effective document control.
  • Medical Device Engineers Wanting to Spend Less Time on Documentation
    Explore ways to reduce the burden of documentation and focus more on design and manufacturing activities.
  • Compliance Officers Concerned About Legacy Document Systems
    Understand how to transition from outdated manual systems to modern, automated solutions that enhance compliance.
  • Operations Managers Focused on Reducing Compliance-Related Delays
    Implement strategies to streamline workflows and reduce delays caused by complex document control systems.
  • IT Professionals Managing Document Control Software for Regulatory Compliance
    Learn how to optimize automation tools and fully leverage your document management systems to support compliance.
  • Executive Leaders Looking to Ensure Company-Wide Regulatory Alignment
    Gain insights on how to simplify compliance and boost efficiency across departments, ensuring adherence to 21 CFR Part 820.