Instructor :
Charles H. Paul

Webinar ID:
10916

• • Feeling the pressure of ever-tightening regulations?
  • Struggling to balance speed-to-market with uncompromising quality and safety standards?

This is NOT your typical training. This 2-day intensive bootcamp is designed to transform you into a medical device quality and compliance expert.

What You’ll Gain in Just Two Days:

• • Deep Regulatory Insights: Navigate the intricate world of medical device compliance, covering the latest standards of ISO 13485 and Good Manufacturing Practices (GMPs). Gain up-to-date knowledge aligned with FDA expectations and global market demands.
  • Advanced Risk Management: Master the identification and mitigation of risks using advanced tools like FTA, FMEA, and FMECA. Learn through real-world scenarios and simulations, ensuring you can effectively implement these techniques within your operations.
  • Quality Systems Excellence: Build a robust quality management framework for your organization. Move beyond theory with practical insights into achieving operational excellence and enhancing product quality.

Course Breakdown:

Day 1:

• • Foundational Overview of Quality Management Systems and GMPs, providing a strong base.
  • Transition into a deep dive into risk management, equipping you with the context and skills to handle more complex risk assessment techniques.

Day 2:

• • Focus on implementing quality systems with a detailed exploration of advanced GMP practices.
  • Build on the knowledge from Day 1 for a natural progression, making it easier to apply concepts in real-world settings.

Why Attend?

• • Engage with industry-leading experts through interactive sessions designed to inform and inspire.
  • Address your specific challenges while networking with peers from across the industry.
  • Turn regulatory hurdles into growth opportunities, positioning yourself as a leader in compliance.

Don’t miss this chance to elevate your expertise and contribute to your organization’s success with cutting-edge compliance strategies.

Join Now!

• • Feeling the pressure of ever-tightening regulations?
  • Struggling to balance speed-to-market with uncompromising quality and safety standards?

This is NOT your typical training. This 2-day intensive bootcamp is designed to transform you into a medical device quality and compliance expert.

What You’ll Gain in Just Two Days:

• • Deep Regulatory Insights: Navigate the intricate world of medical device compliance, covering the latest standards of ISO 13485 and Good Manufacturing Practices (GMPs). Gain up-to-date knowledge aligned with FDA expectations and global market demands.
  • Advanced Risk Management: Master the identification and mitigation of risks using advanced tools like FTA, FMEA, and FMECA. Learn through real-world scenarios and simulations, ensuring you can effectively implement these techniques within your operations.
  • Quality Systems Excellence: Build a robust quality management framework for your organization. Move beyond theory with practical insights into achieving operational excellence and enhancing product quality.

Course Breakdown:

Day 1:

• • Foundational Overview of Quality Management Systems and GMPs, providing a strong base.
  • Transition into a deep dive into risk management, equipping you with the context and skills to handle more complex risk assessment techniques.

Day 2:

• • Focus on implementing quality systems with a detailed exploration of advanced GMP practices.
  • Build on the knowledge from Day 1 for a natural progression, making it easier to apply concepts in real-world settings.

Why Attend?

• • Engage with industry-leading experts through interactive sessions designed to inform and inspire.
  • Address your specific challenges while networking with peers from across the industry.
  • Turn regulatory hurdles into growth opportunities, positioning yourself as a leader in compliance.

Don’t miss this chance to elevate your expertise and contribute to your organization’s success with cutting-edge compliance strategies.

Join Now!

The medical device industry is evolving rapidly, with new challenges on the horizon in 2025. Now is the time to get ahead and position yourself for success in the coming year.

Use your end-of-year training budget to invest in this exclusive boot camp and save big. Register by November 30, 2024, and enjoy a 20% early bird discount.

Missed the November deadline? No worries—register by December 31, 2024, to save 10% before prices return to normal in January.

Are You Facing These Challenges?

• • Worried about hidden compliance risks that could delay product approvals?
  • Struggling to align with evolving ISO 13485 standards without impacting your time-to-market?
  • Pressured to ensure audit readiness while balancing operational efficiency?

How This 2-Day Bootcamp Will Help You:

• For Individuals:
  • Master ISO 13485 updates and advanced risk management techniques to minimize regulatory delays and ensure a seamless path to approval.
  • Become a valuable asset to your organization with skills that boost compliance and product quality.
• For Leaders:
  • Empower your team with cutting-edge knowledge, streamline quality systems, and turn compliance into a competitive advantage.
  • Save on training costs now and equip your team to handle the regulatory challenges of 2025.

This bootcamp is your chance to stay ahead of the competition and make the most of end-of-year savings. Invest in your growth and set yourself up for success in 2025 with early bird pricing.

Join Now and turn compliance into an opportunity for innovation and growth.

The medical device industry is evolving rapidly, with new challenges on the horizon in 2025. Now is the time to get ahead and position yourself for success in the coming year.

Use your end-of-year training budget to invest in this exclusive boot camp and save big. Register by November 30, 2024, and enjoy a 20% early bird discount.

Missed the November deadline? No worries—register by December 31, 2024, to save 10% before prices return to normal in January.

Are You Facing These Challenges?

• • Worried about hidden compliance risks that could delay product approvals?
  • Struggling to align with evolving ISO 13485 standards without impacting your time-to-market?
  • Pressured to ensure audit readiness while balancing operational efficiency?

How This 2-Day Bootcamp Will Help You:

• For Individuals:
  • Master ISO 13485 updates and advanced risk management techniques to minimize regulatory delays and ensure a seamless path to approval.
  • Become a valuable asset to your organization with skills that boost compliance and product quality.
• For Leaders:
  • Empower your team with cutting-edge knowledge, streamline quality systems, and turn compliance into a competitive advantage.
  • Save on training costs now and equip your team to handle the regulatory challenges of 2025.

This bootcamp is your chance to stay ahead of the competition and make the most of end-of-year savings. Invest in your growth and set yourself up for success in 2025 with early bird pricing.

Join Now and turn compliance into an opportunity for innovation and growth.

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

Day 1: Establishing the Basics and Building on Risk Management: 6-hrs.

Module 1: Overview of Quality Management and GMPs

• • Overview/Basic Elements of the Quality Management System
  • Delve into the Fundamental Components that Define a Robust Quality Management System
  • What are the regulations governing Good Manufacturing Practices?
  • Quality Management in GMPs

Module 2: Deep Dive into Risk Management Techniques

• • Risk Analysis Defined
  • Why Risk/Hazard Analysis is Important
  • Regulatory Requirements including EU MDR and ISO 14971
  • Management Responsibility as it Relates to Risk Management

Module 3: Risk Management Process and Evaluation

• • Risk Management Process and Procedure
  • The Risk Management Plan and Documentation
  • Risk Analysis Processes and Techniques: Asking the Right Questions, FTA, FMEA, FMECA

Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Day 2: Advanced GMPs and Integrating Quality Systems: 6-hrs.

Module 1: Implementing and Managing Quality Systems

• • Key Attributes of a Functional Quality System
  • Implementing Your Quality System in Conformance with ISO 13485 Standards
  • Typical Quality System Elements: QSR vs ISO Compliance
  • ISO 13485 Content Overview and Evolution of Revisions

Module 2: Advanced GMP Practices

• • Personnel, Premises and Equipment
  • Documentation: Production, Quality Assurance, Materials Management
  • Production and In-process Controls, Packaging and Labeling

Module 3: GMP Compliance and Oversight

• • Storage and Distribution, Laboratory Controls, Validation
  • Change Control, Rejection and Re-use of Materials
  • Complaints and Recalls, Supplier Controls

BONUS:

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

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

Day 1: Establishing the Basics and Building on Risk Management: 6-hrs.

Module 1: Overview of Quality Management and GMPs

• • Overview/Basic Elements of the Quality Management System
  • Delve into the Fundamental Components that Define a Robust Quality Management System
  • What are the regulations governing Good Manufacturing Practices?
  • Quality Management in GMPs

Module 2: Deep Dive into Risk Management Techniques

• • Risk Analysis Defined
  • Why Risk/Hazard Analysis is Important
  • Regulatory Requirements including EU MDR and ISO 14971
  • Management Responsibility as it Relates to Risk Management

Module 3: Risk Management Process and Evaluation

• • Risk Management Process and Procedure
  • The Risk Management Plan and Documentation
  • Risk Analysis Processes and Techniques: Asking the Right Questions, FTA, FMEA, FMECA

Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Day 2: Advanced GMPs and Integrating Quality Systems: 6-hrs.

Module 1: Implementing and Managing Quality Systems

• • Key Attributes of a Functional Quality System
  • Implementing Your Quality System in Conformance with ISO 13485 Standards
  • Typical Quality System Elements: QSR vs ISO Compliance
  • ISO 13485 Content Overview and Evolution of Revisions

Module 2: Advanced GMP Practices

• • Personnel, Premises and Equipment
  • Documentation: Production, Quality Assurance, Materials Management
  • Production and In-process Controls, Packaging and Labeling

Module 3: GMP Compliance and Oversight

• • Storage and Distribution, Laboratory Controls, Validation
  • Change Control, Rejection and Re-use of Materials
  • Complaints and Recalls, Supplier Controls

BONUS:

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!

• • Leaders Seeking to Empower Their Teams: Equip your team with the latest risk management and quality compliance skills to accelerate product development and reduce regulatory setbacks.
  • Quality Assurance Managers Focused on Reducing Compliance Risks: Gain practical insights to enhance quality systems and streamline compliance, minimizing the chance of costly mistakes.
  • Regulatory Affairs Specialists Struggling With Changing Standards: Stay updated on ISO 13485 and GMP requirements, ensuring your organization remains aligned with FDA expectations.
  • Training Heads Designing Custom Learning Paths: Provide your team with a comprehensive understanding of risk assessment tools and quality management systems to foster continuous improvement.
  • Product Development Managers Looking to Mitigate Risks Early: Learn to integrate risk management seamlessly into the design process, reducing time-to-market without compromising on product safety.
  • Operations Managers Focused on Improving Process Efficiency: Understand how to implement GMPs effectively, ensuring smooth production and consistent product quality throughout the manufacturing lifecycle.
  • HR Professionals Aiming to Boost Team Competency: Identify critical compliance skills needed in the industry and upskill your team to tackle regulatory challenges confidently.
  • Medical Device Engineers Striving for Design Excellence: Gain mastery over risk analysis techniques like FMEA and FTA, ensuring your device designs meet safety standards.
  • Compliance Officers Concerned About Audit Readiness: Ensure your organization is audit-ready by building a robust quality management framework that meets international standards and regulatory requirements.

Maximize The Learning Experience in A Group Setting!

• • Leaders Seeking to Empower Their Teams: Equip your team with the latest risk management and quality compliance skills to accelerate product development and reduce regulatory setbacks.
  • Quality Assurance Managers Focused on Reducing Compliance Risks: Gain practical insights to enhance quality systems and streamline compliance, minimizing the chance of costly mistakes.
  • Regulatory Affairs Specialists Struggling With Changing Standards: Stay updated on ISO 13485 and GMP requirements, ensuring your organization remains aligned with FDA expectations.
  • Training Heads Designing Custom Learning Paths: Provide your team with a comprehensive understanding of risk assessment tools and quality management systems to foster continuous improvement.
  • Product Development Managers Looking to Mitigate Risks Early: Learn to integrate risk management seamlessly into the design process, reducing time-to-market without compromising on product safety.
  • Operations Managers Focused on Improving Process Efficiency: Understand how to implement GMPs effectively, ensuring smooth production and consistent product quality throughout the manufacturing lifecycle.
  • HR Professionals Aiming to Boost Team Competency: Identify critical compliance skills needed in the industry and upskill your team to tackle regulatory challenges confidently.
  • Medical Device Engineers Striving for Design Excellence: Gain mastery over risk analysis techniques like FMEA and FTA, ensuring your device designs meet safety standards.
  • Compliance Officers Concerned About Audit Readiness: Ensure your organization is audit-ready by building a robust quality management framework that meets international standards and regulatory requirements.