Achieving Excellence with ISO 13485: A Comprehensive Guide to Medical Device Quality Management
Mastering Quality, Ensuring Compliance- Your Pathway to ISO 13485 Excellence!
Instructor :
Charles H. Paul
Webinar ID:
9703
Date: DEC 27, 2024 (FRI)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
-
- Quality Management System Fundamentals: Core Principles And Elements For Excellence.
- Standard Quality System Elements: Key Components Of Effective Quality Management.
- Functional Quality System Attributes: Essentials For Successful …
-
- Quality Management System Fundamentals: Core Principles And Elements For Excellence.
- Standard Quality System Elements: Key Components Of Effective Quality Management.
- Functional Quality System Attributes: Essentials For Successful System Implementation.
- QSR Vs. ISO Compliance: Understanding Distinctive Requirements And Impacts.
- ISO 13485 Overview & Revisions: Evolution And Significance Of The Standard.
- Quality System Implementation: Aligning With ISO 13485 For Optimal Compliance.
Course Description
Learn How to Successfully Apply the Principles of Quality Management to Your Organization.
ISO 13485 remains a cornerstone for regulatory compliance in the medical device industry, outlining standards for a comprehensive quality management system (QMS).
This webinar unpacks the complexities of ISO 13485, providing attendees with a roadmap to achieving and maintaining certification.
ISO 13485 is the international quality management system standard for medical devices. The function of this standard is to “specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”
With a focus on aligning with global regulatory requirements, this training covers everything from documentation and procedures to continuous improvement practices that ensure compliance and enhance product safety.
Charles Paul will guide you through critical elements, helping you understand how to integrate these standards into your daily operations.
In this interactive webinar:
- We will begin this webinar by overviewing the quality management system concept extended to both the QSR and the ISO standard to provide a solid and appropriate background to the further discussion of the standard.
- We will next discuss the overall intent and impact of ISO 13485 in terms of why it is important and what it is intended to accomplish.
- Once those basic concepts are covered, we’ll overview the contents of the standard, and the impact of the various revisions and their specific change focus up to and including ISO 13485:2016.
- We will spend some time discussing the differences between 21 CFR820 and the ISO Standard to fully realize the concept of conformance versus compliance.
- We will end this webinar by discussing the process of implementing your quality system in conformance with the standard.
Join Now!
Learn How to Successfully Apply the Principles of Quality Management to Your Organization.
ISO 13485 remains a cornerstone for regulatory compliance in the medical device industry, outlining standards for a comprehensive quality management system (QMS).
This webinar unpacks the complexities of ISO 13485, providing attendees with a roadmap to achieving and maintaining certification.
ISO 13485 is the international quality management system standard for medical devices. The function of this standard is to “specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”
With a focus on aligning with global regulatory requirements, this training covers everything from documentation and procedures to continuous improvement practices that ensure compliance and enhance product safety.
Charles Paul will guide you through critical elements, helping you understand how to integrate these standards into your daily operations.
In this interactive webinar:
- We will begin this webinar by overviewing the quality management system concept extended to both the QSR and the ISO standard to provide a solid and appropriate background to the further discussion of the standard.
- We will next discuss the overall intent and impact of ISO 13485 in terms of why it is important and what it is intended to accomplish.
- Once those basic concepts are covered, we’ll overview the contents of the standard, and the impact of the various revisions and their specific change focus up to and including ISO 13485:2016.
- We will spend some time discussing the differences between 21 CFR820 and the ISO Standard to fully realize the concept of conformance versus compliance.
- We will end this webinar by discussing the process of implementing your quality system in conformance with the standard.
Join Now!
Why you should attend
As medical device regulations continue to tighten, understanding and implementing ISO 13485 can distinguish your company in a competitive market!
This webinar offers a deep dive into the standards and provides practical strategies for applying them effectively within your quality management systems
ISO 13485 is a standard and not a regulation. In the US, it is vital to understand the differences between a standard and a regulation to avoid serious compliance failures.
That said, the standard is just that, a standard, and is the standard of choice for medical device manufacturers as it pertains to their quality management system.
- Certification under this standard is essential to the organization’s ability to conduct business in the various markets that require conformity to this standard and compliance to its country’s regulations.
- The ISO standard is also a valuable tool to the establishment, maintenance, and execution of the organization’s QMS as long as any variances to existing country regulations are understood i.e. the difference between a regulation and a standard.
This webinar will establish above foundation.
” Charles Paul’s expertise will help you navigate the certification process, ensuring your QMS is not only compliant but also efficient and robust. Attend this session to elevate your QMS, reduce risks, and position your company as a leader in medical device quality and safety.“
Enroll Now!
As medical device regulations continue to tighten, understanding and implementing ISO 13485 can distinguish your company in a competitive market!
This webinar offers a deep dive into the standards and provides practical strategies for applying them effectively within your quality management systems
ISO 13485 is a standard and not a regulation. In the US, it is vital to understand the differences between a standard and a regulation to avoid serious compliance failures.
That said, the standard is just that, a standard, and is the standard of choice for medical device manufacturers as it pertains to their quality management system.
- Certification under this standard is essential to the organization’s ability to conduct business in the various markets that require conformity to this standard and compliance to its country’s regulations.
- The ISO standard is also a valuable tool to the establishment, maintenance, and execution of the organization’s QMS as long as any variances to existing country regulations are understood i.e. the difference between a regulation and a standard.
This webinar will establish above foundation.
” Charles Paul’s expertise will help you navigate the certification process, ensuring your QMS is not only compliant but also efficient and robust. Attend this session to elevate your QMS, reduce risks, and position your company as a leader in medical device quality and safety.“
Enroll Now!
Course Agenda
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.
Overview/Basic Elements Of The Quality Management System
-
- Delve Into The Fundamental Components That Define A Robust Quality Management System. Uncover The Core Principles That Drive Excellence.
Typical Quality System Elements
-
- Explore The Standard Elements Of A Quality System. Discover What Constitutes The Backbone Of Effective Quality Management.
Key Attributes Of A Functional Quality System
-
- Understand The Essential Qualities That Make A Quality System Functional And Efficient. Identify The Hallmarks Of A Successful Implementation.
QSR Vs ISO Compliance
-
- Contrast The Nuances Between QSR And ISO Compliance. Grasp The Distinctive Requirements And How They Impact Quality Management.
ISO 13485 Content Overview And Evolution Of Revisions
-
- Journey Through The ISO 13485 Content, From Its Inception To The Latest Revisions. Understand The Evolution And Why It Matters.
Implementing Your Quality System In Conformance With The Standard
-
- Master The Art Of Implementing A Quality System That Aligns Seamlessly With ISO 13485 Standards. Turn Theory Into Practice For Optimal Compliance.
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
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.
Overview/Basic Elements Of The Quality Management System
-
- Delve Into The Fundamental Components That Define A Robust Quality Management System. Uncover The Core Principles That Drive Excellence.
Typical Quality System Elements
-
- Explore The Standard Elements Of A Quality System. Discover What Constitutes The Backbone Of Effective Quality Management.
Key Attributes Of A Functional Quality System
-
- Understand The Essential Qualities That Make A Quality System Functional And Efficient. Identify The Hallmarks Of A Successful Implementation.
QSR Vs ISO Compliance
-
- Contrast The Nuances Between QSR And ISO Compliance. Grasp The Distinctive Requirements And How They Impact Quality Management.
ISO 13485 Content Overview And Evolution Of Revisions
-
- Journey Through The ISO 13485 Content, From Its Inception To The Latest Revisions. Understand The Evolution And Why It Matters.
Implementing Your Quality System In Conformance With The Standard
-
- Master The Art Of Implementing A Quality System That Aligns Seamlessly With ISO 13485 Standards. Turn Theory Into Practice For Optimal Compliance.
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
Who is this course for
The following benefits from watching this. Even better when done as a group!
FUNCTIONS
- marketing
- research & development
- technical services
- manufacturing
- compliance and regulatory
- logistics/supply chain
- service and maintenance
POSITIONS
- Associates
- Supervisors
- Managers
- Directors
- Vice Presidents
The following benefits from watching this. Even better when done as a group!
FUNCTIONS
- marketing
- research & development
- technical services
- manufacturing
- compliance and regulatory
- logistics/supply chain
- service and maintenance
POSITIONS
- Associates
- Supervisors
- Managers
- Directors
- Vice Presidents
Instructor Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance and compliance-related problems.
