Instructor :
Charles H. Paul

Webinar ID:
9744

As 2024 comes to a close, it’s time to gear up for the next wave of challenges and opportunities in medical device quality systems.

This 4-hour webinar equips you with the tools and insights needed to seamlessly integrate 21 CFR 820 and ISO 13485, ensuring your organization is ready to thrive in 2025 and beyond.

What You’ll Learn:

• • Bridge Compliance and Innovation: Stay ahead by aligning regulatory frameworks with emerging digital transformation trends, including the use of AI and Machine Learning in compliance.
  • Lead on Sustainability: Understand the role of Environmental, Social, and Governance (ESG) in driving sustainable medical device manufacturing.
  • Adapt to Regulatory Shifts: Tackle the post-COVID-19 compliance landscape and learn strategies to meet evolving 21 CFR 820 and ISO 13485 requirements.
  • Fortify Cybersecurity: Safeguard against risks in the era of connected devices and build resilient systems for the Internet of Medical Things (IoMT).
  • Prepare for Personalization: Explore how trends in personalized medical devices and treatments impact quality system requirements.

Why Join Now?

• • Equip your team to be proactive, adaptable, and compliant as the industry enters a new chapter in 2025.
  • Gain practical, real-world strategies through case studies and expert insights to enhance quality system implementation and integration.
  • Stay ahead of global trends and regulatory expectations, positioning yourself as a leader in medical device quality and compliance.

Don’t miss this opportunity to close out 2024 with a solid plan to navigate the complex and evolving medical device landscape.

Register Today and start 2025 with confidence!

As 2024 comes to a close, it’s time to gear up for the next wave of challenges and opportunities in medical device quality systems.

This 4-hour webinar equips you with the tools and insights needed to seamlessly integrate 21 CFR 820 and ISO 13485, ensuring your organization is ready to thrive in 2025 and beyond.

What You’ll Learn:

• • Bridge Compliance and Innovation: Stay ahead by aligning regulatory frameworks with emerging digital transformation trends, including the use of AI and Machine Learning in compliance.
  • Lead on Sustainability: Understand the role of Environmental, Social, and Governance (ESG) in driving sustainable medical device manufacturing.
  • Adapt to Regulatory Shifts: Tackle the post-COVID-19 compliance landscape and learn strategies to meet evolving 21 CFR 820 and ISO 13485 requirements.
  • Fortify Cybersecurity: Safeguard against risks in the era of connected devices and build resilient systems for the Internet of Medical Things (IoMT).
  • Prepare for Personalization: Explore how trends in personalized medical devices and treatments impact quality system requirements.

Why Join Now?

• • Equip your team to be proactive, adaptable, and compliant as the industry enters a new chapter in 2025.
  • Gain practical, real-world strategies through case studies and expert insights to enhance quality system implementation and integration.
  • Stay ahead of global trends and regulatory expectations, positioning yourself as a leader in medical device quality and compliance.

Don’t miss this opportunity to close out 2024 with a solid plan to navigate the complex and evolving medical device landscape.

Register Today and start 2025 with confidence!

In the fast-paced and highly regulated medical device industry, staying ahead of evolving standards is critical.

This 4-hour training provides the essential knowledge and skills you need to navigate the complex landscape of FDA Quality System Regulation (21 CFR 820) and ISO 13485 with confidence and precision.

Key Benefits of Attending:

• • Master Compliance: Gain an in-depth understanding of FDA Quality System Regulation and ISO 13485, ensuring your organization meets the latest regulatory expectations.
  • Stay Ahead of Trends: Learn how emerging technologies like AI, IoMT, and digital transformation impact compliance and how to adapt effectively.
  • Mitigate Risks: Enhance your ability to address regulatory risks and maintain the safety and efficacy of medical devices, paving the way for smoother market access.
  • Boost Your Career: Build expertise in critical regulatory frameworks, positioning yourself as a leader in quality assurance and regulatory affairs.

This training is ideal for professionals in:

• • Regulatory Affairs: Stay updated on compliance requirements.
  • Quality Assurance: Strengthen your quality systems to meet global standards.
  • R&D and Manufacturing: Align processes with regulatory expectations for safer and more effective devices.
  • Leadership Roles: Drive innovation while ensuring regulatory adherence.

What Makes This Training Unique?

• • Engage with real-world case studies to understand practical applications.
  • Participate in interactive discussions that address specific challenges and offer actionable solutions.
  • Leave with tools and strategies you can immediately apply to your work, enabling you to make a tangible impact within your organization.

Whether you’re looking to expand your expertise or solidify your foundation in medical device regulations, this training equips you to excel in your role and advance your career.

Register Today and ensure you’re prepared to lead your organization into the future of medical device quality systems!

In the fast-paced and highly regulated medical device industry, staying ahead of evolving standards is critical.

This 4-hour training provides the essential knowledge and skills you need to navigate the complex landscape of FDA Quality System Regulation (21 CFR 820) and ISO 13485 with confidence and precision.

Key Benefits of Attending:

• • Master Compliance: Gain an in-depth understanding of FDA Quality System Regulation and ISO 13485, ensuring your organization meets the latest regulatory expectations.
  • Stay Ahead of Trends: Learn how emerging technologies like AI, IoMT, and digital transformation impact compliance and how to adapt effectively.
  • Mitigate Risks: Enhance your ability to address regulatory risks and maintain the safety and efficacy of medical devices, paving the way for smoother market access.
  • Boost Your Career: Build expertise in critical regulatory frameworks, positioning yourself as a leader in quality assurance and regulatory affairs.

This training is ideal for professionals in:

• • Regulatory Affairs: Stay updated on compliance requirements.
  • Quality Assurance: Strengthen your quality systems to meet global standards.
  • R&D and Manufacturing: Align processes with regulatory expectations for safer and more effective devices.
  • Leadership Roles: Drive innovation while ensuring regulatory adherence.

What Makes This Training Unique?

• • Engage with real-world case studies to understand practical applications.
  • Participate in interactive discussions that address specific challenges and offer actionable solutions.
  • Leave with tools and strategies you can immediately apply to your work, enabling you to make a tangible impact within your organization.

Whether you’re looking to expand your expertise or solidify your foundation in medical device regulations, this training equips you to excel in your role and advance your career.

Register Today and ensure you’re prepared to lead your organization into the future of medical device quality systems!

I. Introduction

A. Importance of Quality Systems in the Medical Device Industry

B. Overview of 21CFR 820 and ISO 13485 Standards

II. Regulatory Framework

A. Comparison of 21CFR 820 and ISO 13485

• • Key Similarities
  • Key Differences

B. Understanding the Regulatory Landscape

• • FDA Regulations for Medical Devices
  • Global Harmonization and Regulatory Convergence

III. 21CFR 820: Quality System Regulation

A. Scope and Applicability

B. Key Requirements and Subparts

• • Management Responsibility (Subpart B)
  • Design Controls (Subpart C)
  • Document Controls (Subpart D)
  • Production and Process Controls (Subpart E)
  • Corrective and Preventive Action (CAPA) (Subpart J)
  • Complaint Files (Subpart M)

IV. ISO 13485: Medical Devices – Quality Management Systems

A. Overview and Purpose of ISO 13485

B. Structure and Key Requirements

• • Management Responsibility (Clause 5)
  • Design and Development (Clause 7)
  • Production and Service Provision (Clause 7)
  • Measurement, Analysis, and Improvement (Clause 8)

C. Achieving ISO 13485 Certification

• • Documentation and Record-Keeping
  • Internal and External Audits

V. Integration and Compliance

A. Developing an Integrated Quality Management System

• • Overlapping Requirements
  • Streamlining Processes for Efficiency

B. Ensuring Compliance with Evolving Standards

• • Staying Informed on Regulatory Updates
  • Adapting to Industry Changes

VI. Best Practices and Continuous Improvement

A. Implementing Best Practices for Quality Management

• • Risk Management Strategies
  • Training and Competency Programs

B. Strategies for Continuous Improvement

• • Monitoring and Measuring Performance
  • Feedback Loops and Process Optimization

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. Introduction

A. Importance of Quality Systems in the Medical Device Industry

B. Overview of 21CFR 820 and ISO 13485 Standards

II. Regulatory Framework

A. Comparison of 21CFR 820 and ISO 13485

• • Key Similarities
  • Key Differences

B. Understanding the Regulatory Landscape

• • FDA Regulations for Medical Devices
  • Global Harmonization and Regulatory Convergence

III. 21CFR 820: Quality System Regulation

A. Scope and Applicability

B. Key Requirements and Subparts

• • Management Responsibility (Subpart B)
  • Design Controls (Subpart C)
  • Document Controls (Subpart D)
  • Production and Process Controls (Subpart E)
  • Corrective and Preventive Action (CAPA) (Subpart J)
  • Complaint Files (Subpart M)

IV. ISO 13485: Medical Devices – Quality Management Systems

A. Overview and Purpose of ISO 13485

B. Structure and Key Requirements

• • Management Responsibility (Clause 5)
  • Design and Development (Clause 7)
  • Production and Service Provision (Clause 7)
  • Measurement, Analysis, and Improvement (Clause 8)

C. Achieving ISO 13485 Certification

• • Documentation and Record-Keeping
  • Internal and External Audits

V. Integration and Compliance

A. Developing an Integrated Quality Management System

• • Overlapping Requirements
  • Streamlining Processes for Efficiency

B. Ensuring Compliance with Evolving Standards

• • Staying Informed on Regulatory Updates
  • Adapting to Industry Changes

VI. Best Practices and Continuous Improvement

A. Implementing Best Practices for Quality Management

• • Risk Management Strategies
  • Training and Competency Programs

B. Strategies for Continuous Improvement

• • Monitoring and Measuring Performance
  • Feedback Loops and Process Optimization

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

The following benefits from watching this. Even better when done as a group!

• • Regulatory Professionals Seeking to Master Compliance
  • Quality Assurance Experts Aiming for Operational Excellence
  • Leaders Driving Innovation While Ensuring Compliance
  • R&D Teams Developing Safer, Compliant Medical Devices
  • Manufacturing Heads Focused on Risk Mitigation
  • Training Coordinators Designing Learning Paths for Compliance Teams
  • HR Professionals Focused on Upskilling Teams in Medical Devices
  • Department Heads Seeking Cross-Functional Quality Integration
  • Professionals Navigating Emerging Trends in Quality Systems

The following benefits from watching this. Even better when done as a group!

• • Regulatory Professionals Seeking to Master Compliance
  • Quality Assurance Experts Aiming for Operational Excellence
  • Leaders Driving Innovation While Ensuring Compliance
  • R&D Teams Developing Safer, Compliant Medical Devices
  • Manufacturing Heads Focused on Risk Mitigation
  • Training Coordinators Designing Learning Paths for Compliance Teams
  • HR Professionals Focused on Upskilling Teams in Medical Devices
  • Department Heads Seeking Cross-Functional Quality Integration
  • Professionals Navigating Emerging Trends in Quality Systems