Instructor :
Charles H. Paul

Webinar ID:
9744

In this webinar, we delve into the evolution of Medical Device Quality Systems, focusing on 21 CFR 820 and ISO 13485 in the context of 2024’s industry trends.

Participants will explore the critical integration of these regulatory frameworks with digital transformation trends, including the increasing role of AI and Machine Learning in medical device development and compliance.

The course addresses the heightened industry focus on sustainability and Environmental, Social, and Governance (ESG) goals, examining their impact on medical device manufacturing and lifecycle management.

We will also tackle the challenges and strategies in navigating the post-COVID-19 regulatory landscape, ensuring adherence to 21 CFR 820 and ISO 13485 amidst evolving compliance requirements.

A key focus will be the importance of cybersecurity in the era of interconnected medical devices, underscoring the need for robust quality systems in the Internet of Medical Things (IoMT).

Additionally, the trend towards personalized medical devices and treatments will be discussed, highlighting its implications for quality system requirements.

The webinar will emphasize the necessity of adaptability and responsiveness in quality systems to keep pace with the rapidly changing medical device market demands.

Through case studies and expert insights, attendees will gain practical knowledge and tools for effectively implementing and integrating quality systems in compliance with both U.S. and international standards.

Join us for an insightful session to enhance your understanding and skills in navigating the complex and evolving world of medical device quality systems in 2024.

Join Now!

In this webinar, we delve into the evolution of Medical Device Quality Systems, focusing on 21 CFR 820 and ISO 13485 in the context of 2024’s industry trends.

Participants will explore the critical integration of these regulatory frameworks with digital transformation trends, including the increasing role of AI and Machine Learning in medical device development and compliance.

The course addresses the heightened industry focus on sustainability and Environmental, Social, and Governance (ESG) goals, examining their impact on medical device manufacturing and lifecycle management.

We will also tackle the challenges and strategies in navigating the post-COVID-19 regulatory landscape, ensuring adherence to 21 CFR 820 and ISO 13485 amidst evolving compliance requirements.

A key focus will be the importance of cybersecurity in the era of interconnected medical devices, underscoring the need for robust quality systems in the Internet of Medical Things (IoMT).

Additionally, the trend towards personalized medical devices and treatments will be discussed, highlighting its implications for quality system requirements.

The webinar will emphasize the necessity of adaptability and responsiveness in quality systems to keep pace with the rapidly changing medical device market demands.

Through case studies and expert insights, attendees will gain practical knowledge and tools for effectively implementing and integrating quality systems in compliance with both U.S. and international standards.

Join us for an insightful session to enhance your understanding and skills in navigating the complex and evolving world of medical device quality systems in 2024.

Join Now!

Enrolling in this training is essential for those aiming to master the regulatory landscapes of the medical device industry.

• This session offers an in-depth exploration of the FDA Quality System Regulation and ISO 13485.
• Participants will gain valuable insights and practical tools for navigating the complexities of compliance requirements.

By attending, you will enhance your skills in ensuring the safety and efficacy of medical devices, effectively mitigating regulatory risks, and facilitating smoother market access.

This training is particularly beneficial for professionals in regulatory affairs, quality assurance, research and development, manufacturing, and leadership roles.

Expect to engage with real-world case studies and participate in interactive discussions, which will provide practical insights.

These elements are designed to allow participants to directly apply their newfound knowledge to their organizational contexts.

This training is not just about learning the regulations; it’s about empowering you to contribute significantly to the success of your medical device initiatives.

Whether you are looking to enhance your existing knowledge or seeking to build a foundation in medical device regulatory frameworks, this training will equip you with the expertise to make a tangible impact in your field.

Enroll Now!

Enrolling in this training is essential for those aiming to master the regulatory landscapes of the medical device industry.

• This session offers an in-depth exploration of the FDA Quality System Regulation and ISO 13485.
• Participants will gain valuable insights and practical tools for navigating the complexities of compliance requirements.

By attending, you will enhance your skills in ensuring the safety and efficacy of medical devices, effectively mitigating regulatory risks, and facilitating smoother market access.

This training is particularly beneficial for professionals in regulatory affairs, quality assurance, research and development, manufacturing, and leadership roles.

Expect to engage with real-world case studies and participate in interactive discussions, which will provide practical insights.

These elements are designed to allow participants to directly apply their newfound knowledge to their organizational contexts.

This training is not just about learning the regulations; it’s about empowering you to contribute significantly to the success of your medical device initiatives.

Whether you are looking to enhance your existing knowledge or seeking to build a foundation in medical device regulatory frameworks, this training will equip you with the expertise to make a tangible impact in your field.

Enroll Now!

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:

• PDF copy of the presentation handout for your future reference.
• Soft copy of the certificate of completion on request.
• 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:

• PDF copy of the presentation handout for your future reference.
• Soft copy of the certificate of completion on request.
• 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 Affairs Teams: Professionals in regulatory affairs play a crucial role in ensuring compliance with FDA regulations and international standards. This training will enhance their understanding of both 21 CFR 820 and ISO 13485, providing them with the knowledge and tools to navigate complex regulatory landscapes.
• Quality Assurance and Quality Control Personnel: Individuals responsible for maintaining and ensuring product quality will gain practical insights into implementing and sustaining effective quality management systems. This training will equip them with the skills needed to monitor and enhance compliance with regulatory requirements.
• Research and Development Teams: R&D teams involved in the design and development of medical devices will benefit from understanding the regulatory frameworks that govern their work. Insights from the training can be applied to design processes that align with both FDA QSR and international quality standards.
• Manufacturing and Operations Teams: Professionals involved in the production and distribution of medical devices will gain a deeper understanding of quality management practices. This knowledge will contribute to the implementation of compliant manufacturing processes and efficient operations that adhere to regulatory requirements.
• Senior Management and Executives: Leadership teams will benefit from a strategic perspective on regulatory compliance. This training will provide them with insights into the potential impact of compliance on the overall business strategy and help guide decision-making in terms of resource allocation and organizational priorities.
• Auditors and Compliance Officers: Individuals responsible for internal audits and ensuring adherence to regulatory standards will find this training instrumental. It will empower them with the knowledge needed to conduct effective audits and identify areas for improvement in the organization’s quality systems.
• Cross-Functional Teams: Collaboration is crucial for successful compliance. Cross-functional teams that include members from various departments can benefit from a shared understanding of regulatory requirements, fostering a culture of compliance and continuous improvement throughout the organization

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

• Regulatory Affairs Teams: Professionals in regulatory affairs play a crucial role in ensuring compliance with FDA regulations and international standards. This training will enhance their understanding of both 21 CFR 820 and ISO 13485, providing them with the knowledge and tools to navigate complex regulatory landscapes.
• Quality Assurance and Quality Control Personnel: Individuals responsible for maintaining and ensuring product quality will gain practical insights into implementing and sustaining effective quality management systems. This training will equip them with the skills needed to monitor and enhance compliance with regulatory requirements.
• Research and Development Teams: R&D teams involved in the design and development of medical devices will benefit from understanding the regulatory frameworks that govern their work. Insights from the training can be applied to design processes that align with both FDA QSR and international quality standards.
• Manufacturing and Operations Teams: Professionals involved in the production and distribution of medical devices will gain a deeper understanding of quality management practices. This knowledge will contribute to the implementation of compliant manufacturing processes and efficient operations that adhere to regulatory requirements.
• Senior Management and Executives: Leadership teams will benefit from a strategic perspective on regulatory compliance. This training will provide them with insights into the potential impact of compliance on the overall business strategy and help guide decision-making in terms of resource allocation and organizational priorities.
• Auditors and Compliance Officers: Individuals responsible for internal audits and ensuring adherence to regulatory standards will find this training instrumental. It will empower them with the knowledge needed to conduct effective audits and identify areas for improvement in the organization’s quality systems.
• Cross-Functional Teams: Collaboration is crucial for successful compliance. Cross-functional teams that include members from various departments can benefit from a shared understanding of regulatory requirements, fostering a culture of compliance and continuous improvement throughout the organization