Document control under 21 CFR Part 820 is often slowed by legacy habits. This 75-minute webinar introduces Lean Documents and Lean Configuration, which apply lean principles to how controlled documents are created, designed, processed and managed in regulated industries.
Before computers and databases, quality teams relied on elaborate numbering schemes, cross-referencing and complex filing systems. Many medical device companies still carry these methods, which limit the benefits of modern automation and information retrieval. Lean Documents offers a streamlined alternative, and Lean Configuration uses software to remove burdens left over from paper systems.
You'll see how these ideas apply to design control documents, manufacturing records and QMS elements under the Quality System Regulation and ISO 13485.
WHY SHOULD YOU ATTEND?
If managing controlled documents takes too much of your time, this session shows how lean principles can simplify creating and maintaining the documentation 21 CFR Part 820 requires, reducing redundancy so you can focus on value-added work.
It suits quality assurance and control staff, regulatory affairs, compliance officers, production managers, process engineers and document control specialists in the medical device industry.
AREA COVERED
- A brief introduction to Lean Documents and Lean Configuration
- The Quality System Regulation, 21 CFR Part 820 and ISO 13485 as they apply to design control documents
- Basic functions in a life sciences manufacturing plant
- Key types of controlled documents and records for manufacturing
- QMS elements controlled through documentation
- Bringing it all together
LEARNING OBJECTIVES
- Explain the principles of Lean Documents and Lean Configuration
- Apply 21 CFR Part 820 and ISO 13485 requirements to design control documents
- Describe the basic functions of a life sciences manufacturing plant
- Identify the key controlled documents and records used in manufacturing
- Map QMS elements to the documents that control them
- Reduce redundancy in document control using lean principles
WHO WILL BENEFIT?
This webinar is designed for professionals within the medical device industry who are involved in the management of quality systems and compliance. It is particularly beneficial for:
- Quality Assurance Managers
- Regulatory Affairs Professionals
- Quality Control Specialists
- Production Managers
- Compliance Officers
- Process Engineers
- Document Control Specialists
If managing controlled documents takes too much of your time, this session shows how lean principles can simplify creating and maintaining the documentation 21 CFR Part 820 requires, reducing redundancy so you can focus on value-added work.
It suits quality assurance and control staff, regulatory affairs, compliance officers, production managers, process engineers and document control specialists in the medical device industry.
- A brief introduction to Lean Documents and Lean Configuration
- The Quality System Regulation, 21 CFR Part 820 and ISO 13485 as they apply to design control documents
- Basic functions in a life sciences manufacturing plant
- Key types of controlled documents and records for manufacturing
- QMS elements controlled through documentation
- Bringing it all together
- Explain the principles of Lean Documents and Lean Configuration
- Apply 21 CFR Part 820 and ISO 13485 requirements to design control documents
- Describe the basic functions of a life sciences manufacturing plant
- Identify the key controlled documents and records used in manufacturing
- Map QMS elements to the documents that control them
- Reduce redundancy in document control using lean principles
This webinar is designed for professionals within the medical device industry who are involved in the management of quality systems and compliance. It is particularly beneficial for:
- Quality Assurance Managers
- Regulatory Affairs Professionals
- Quality Control Specialists
- Production Managers
- Compliance Officers
- Process Engineers
- Document Control Specialists