How to Comply with the FDA’s Quality System Regulation (QSR) – 21 CFR Part 820
Build Your Thorough Understanding of The Regulation to Ensure You are Compliant to It.
Instructor :
Charles H. Paul
Webinar ID:
3179
Date: FEB 28, 2025 (FRI)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
- What is 21 CFR Part 820 and Why is It Important?
- Key Provisions of the Regulation – What You Need
- Management Responsibilities
- CAPA
- Quality Audits, Design Controls, Document Controls
- Production and Process Controls
- What is 21 CFR Part 820 and Why is It Important?
- Key Provisions of the Regulation – What You Need
- Management Responsibilities
- CAPA
- Quality Audits, Design Controls, Document Controls
- Production and Process Controls
- Labeling and Packaging Control
- Key Guidance for Complying with The Regulation
Course Description
21 CFR Part 820, known as the Quality System Regulation QSR outlines the Current Good Manufacturing Practice (cGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished medical devices intended for human use.
The purpose of the regulation? It is very simple – to ensure that medical devices are safe and effective!
Achieving this safety and effectiveness requirement, however, is not so simple. It is achieved by implementing what is known as a “Quality System” consisting of many regulatory requirements as specified in the regulation that must be:
- Documented in the form of Standard Operating Procedures and Work Instructions
- Integrated into the fabric of how the business executes the activities required to place a medical device into the marketplace and manage that device throughout its lifecycle
- Be managed on a daily basis to ensure the organization’s compliance to the tenants of the regulation
- Be provable when externally audited to verify its effectiveness and compliance with the regulation
Join us to learn more…
21 CFR Part 820, known as the Quality System Regulation QSR outlines the Current Good Manufacturing Practice (cGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished medical devices intended for human use.
The purpose of the regulation? It is very simple – to ensure that medical devices are safe and effective!
Achieving this safety and effectiveness requirement, however, is not so simple. It is achieved by implementing what is known as a “Quality System” consisting of many regulatory requirements as specified in the regulation that must be:
- Documented in the form of Standard Operating Procedures and Work Instructions
- Integrated into the fabric of how the business executes the activities required to place a medical device into the marketplace and manage that device throughout its lifecycle
- Be managed on a daily basis to ensure the organization’s compliance to the tenants of the regulation
- Be provable when externally audited to verify its effectiveness and compliance with the regulation
Join us to learn more…
Why you should attend
If you work within the medical device industry, almost everything that you do every day is somehow touched by this regulation. Ignorance of the sections of this regulation is no excuse for non-compliance.
It takes a complete thorough understanding of the regulation to ensure you are compliant to it.
In this interactive webinar, Charles H. Paul, with over two decades of Regulatory and Compliance experience, will provide that level of understanding and basic guidance to assure compliance.
Join us now!
If you work within the medical device industry, almost everything that you do every day is somehow touched by this regulation. Ignorance of the sections of this regulation is no excuse for non-compliance.
It takes a complete thorough understanding of the regulation to ensure you are compliant to it.
In this interactive webinar, Charles H. Paul, with over two decades of Regulatory and Compliance experience, will provide that level of understanding and basic guidance to assure compliance.
Join us now!
Areas Covered
1.What is 21 CFR Part 820 and why is it important?
2.Key Provisions of the Regulation – What you need:
- General provisions of the regulation
- Management responsibilities
- Quality Audits
- Personnel
- Design Controls
- Document Controls
- Purchasing controls
- Identification and traceability
- Production and process controls
- Inspection, measuring and test equipment
- Process validation
- Acceptance
- Non-conforming product
- CAPA
- Labeling and packaging control
- Handling, storage, distribution, and installation
3. Key Guidance for Complying with The Regulation
1.What is 21 CFR Part 820 and why is it important?
2.Key Provisions of the Regulation – What you need:
- General provisions of the regulation
- Management responsibilities
- Quality Audits
- Personnel
- Design Controls
- Document Controls
- Purchasing controls
- Identification and traceability
- Production and process controls
- Inspection, measuring and test equipment
- Process validation
- Acceptance
- Non-conforming product
- CAPA
- Labeling and packaging control
- Handling, storage, distribution, and installation
3. Key Guidance for Complying with The Regulation
Who is this course for
FUNCTIONS
- marketing
- research & development
- technical services
- manufacturing
- compliance and regulatory
- logistics/supply chain
- service and maintenance
POSITIONS
- Associates
- Supervisors
- Managers
- Directors
- Vice Presidents
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 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 training and documentation issues.
