Lean Compliance Unleashed: Transform Your Quality System with 21 CFR Part 820
Streamline Documentation and Achieve Compliance with Lean Principles and Digital Transformation!
Instructor :
Jose Mora
Webinar ID:
12427
Date: DEC 19, 2024 (THU)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
The Compliance Power Pack: Master Quality, Audit, and Risk Management
“Essential Strategies for Achieving Flawless Compliance and Quality Excellence!”
3 Courses Included:
-
- Lean Compliance Unleashed: Transform Your Quality System with 21 CFR Part 820(duration 90 mins), find out more details here
- Mastering FDA Audits: A 6-Hour Virtual Seminar on Preparing, Conducting, and Executing with Confidence (duration 6 hrs), find out more details here
- Mastering Medical Device Quality: A 2-Day Virtual Bootcamp on Risk Management, ISO 13485 & GMP (scheduled for Jan 29-30, 2025, duration 12 hrs), find out more details here
Why Pack Them Together? These three courses offer a comprehensive approach to medical device compliance and quality assurance. They cover everything from understanding key regulations, preparing for audits, to building a robust quality management system that aligns with ISO 13485 and GMP standards.
Why Buy the Pack?
-
- Comprehensive Quality & Compliance Training: Equip your team with essential knowledge across key areas of quality management and audit preparation.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
The Compliance Power Pack: Master Quality, Audit, and Risk Management
“Essential Strategies for Achieving Flawless Compliance and Quality Excellence!”
3 Courses Included:
-
- Lean Compliance Unleashed: Transform Your Quality System with 21 CFR Part 820(duration 90 mins), find out more details here
- Mastering FDA Audits: A 6-Hour Virtual Seminar on Preparing, Conducting, and Executing with Confidence (duration 6 hrs), find out more details here
- Mastering Medical Device Quality: A 2-Day Virtual Bootcamp on Risk Management, ISO 13485 & GMP (scheduled for Jan 29-30, 2025, duration 12 hrs), find out more details here
Why Pack Them Together? These three courses offer a comprehensive approach to medical device compliance and quality assurance. They cover everything from understanding key regulations, preparing for audits, to building a robust quality management system that aligns with ISO 13485 and GMP standards.
Why Buy the Pack?
-
- Comprehensive Quality & Compliance Training: Equip your team with essential knowledge across key areas of quality management and audit preparation.
- Significant Cost Savings: More economical than purchasing each course separately, making it a smart investment for your training budget.
- Get Ahead in 2025: Start the year strong by mastering compliance and quality systems, ensuring smoother operations and fewer compliance issues.
Note: Do you want to custom design your pack and choose courses of your choice? Just drop us an email at support@compliancemeet.com or call at Toll Free: +1 (888) 959-4972. We’ll be happy to help you!
Buy All Three Courses at a 35% discount HERE
What will you learn
-
- Introduction To Lean Documents And Lean Configuration Principles
- Understanding 21 CFR Part 820 And ISO 13485 Requirements
- Key Functions In Life Sciences Manufacturing For Compliance
- Types Of Controlled Documents And Records For Manufacturing Processes
- Managing QMS Elements Through Effective Documentation Practices
- Integrating Lean Principles To Streamline ….
-
- Introduction To Lean Documents And Lean Configuration Principles
- Understanding 21 CFR Part 820 And ISO 13485 Requirements
- Key Functions In Life Sciences Manufacturing For Compliance
- Types Of Controlled Documents And Records For Manufacturing Processes
- Managing QMS Elements Through Effective Documentation Practices
- Integrating Lean Principles To Streamline Quality System Documentation
- Utilizing Digital Tools To Automate And Simplify Compliance Tasks
Course Description
21 CFR Part 820 is the Quality System Regulation (QSR) that governs all medical device manufacturers who operate within or sell to the U.S. market. While the regulation is mandatory, the complexity of your Quality System depends on your internal policies and interpretations.
To remain compliant, life science companies must maintain their Quality Management System (QMS) processes in strict control, using controlled documents and objective evidence such as records to demonstrate adherence.
For medical device manufacturers, the stakes are higher. Under 21 CFR Part 820, each step in the manufacturing process— from work instructions and Standard Operating Procedures (SOPs) to equipment maintenance and support functions—must be documented and maintained through controlled records.
This course introduces the Theory of Lean Documents, which applies lean principles to the creation, management, and control of documents.
By streamlining documentation processes, Lean Documentation reduces waste and inefficiencies typically found in traditional systems.
Additionally, the course will explore Lean Configuration, which uses software solutions to automate and simplify tasks that were once paper-heavy. This transition to digital documentation not only cuts down on manual errors but also improves compliance efficiency.
What You’ll Learn:
-
- How to simplify your QMS while staying compliant with 21 CFR Part 820
- Strategies to apply lean principles to document management, reducing complexity
- The role of software solutions in automating document control
- How to ensure every stage of manufacturing is properly documented and controlled
- Best practices for transitioning from traditional documentation methods to lean, digital systems
By attending, you’ll gain actionable insights to optimize your Quality System, minimize compliance risks, and make your organization more agile and efficient.
Enroll Now!
21 CFR Part 820 is the Quality System Regulation (QSR) that governs all medical device manufacturers who operate within or sell to the U.S. market. While the regulation is mandatory, the complexity of your Quality System depends on your internal policies and interpretations.
To remain compliant, life science companies must maintain their Quality Management System (QMS) processes in strict control, using controlled documents and objective evidence such as records to demonstrate adherence.
For medical device manufacturers, the stakes are higher. Under 21 CFR Part 820, each step in the manufacturing process— from work instructions and Standard Operating Procedures (SOPs) to equipment maintenance and support functions—must be documented and maintained through controlled records.
This course introduces the Theory of Lean Documents, which applies lean principles to the creation, management, and control of documents.
By streamlining documentation processes, Lean Documentation reduces waste and inefficiencies typically found in traditional systems.
Additionally, the course will explore Lean Configuration, which uses software solutions to automate and simplify tasks that were once paper-heavy. This transition to digital documentation not only cuts down on manual errors but also improves compliance efficiency.
What You’ll Learn:
-
- How to simplify your QMS while staying compliant with 21 CFR Part 820
- Strategies to apply lean principles to document management, reducing complexity
- The role of software solutions in automating document control
- How to ensure every stage of manufacturing is properly documented and controlled
- Best practices for transitioning from traditional documentation methods to lean, digital systems
By attending, you’ll gain actionable insights to optimize your Quality System, minimize compliance risks, and make your organization more agile and efficient.
Enroll Now!
Why you should attend
In today’s fast-paced regulatory environment, managing controlled documents can often feel overwhelming. Redundant, repetitive, and poorly organized documentation processes can slow down your team’s productivity, creating frustration and inefficiencies.
If you find yourself struggling with these challenges, this course will offer a fresh perspective and introduce you to a lean, efficient approach to managing your Quality System.
Whether you’re a quality manager, manufacturing supervisor, or compliance officer, this webinar will equip you with actionable strategies to:
-
- Simplify documentation processes by applying lean principles that reduce clutter and inefficiency.
- Free up your design and manufacturing teams so they can focus on what matters—innovating and producing quality products—instead of spending excessive time on paperwork.
- Enhance your team’s productivity and compliance by reducing the time spent managing controlled documents while maintaining high regulatory standards.
- Adopt a proven framework that integrates both traditional methods and modern digital solutions to streamline your Quality Management System.
Key Reasons to Attend:
-
- Cut down on documentation complexity using lean documentation strategies.
- Boost efficiency by leveraging software solutions for controlled document management.
- Ensure compliance with 21 CFR Part 820 while simplifying operational workflows.
- Stay ahead in your role by implementing best practices for managing controlled documents and automating manual tasks.
- Drive your career forward by mastering the skills to create a more agile, efficient, and compliant Quality System.
This training will not only help you overcome common documentation challenges but also position your organization for greater success in regulatory compliance, giving you the tools to optimize operations and enhance team performance.
Register Today!
In today’s fast-paced regulatory environment, managing controlled documents can often feel overwhelming. Redundant, repetitive, and poorly organized documentation processes can slow down your team’s productivity, creating frustration and inefficiencies.
If you find yourself struggling with these challenges, this course will offer a fresh perspective and introduce you to a lean, efficient approach to managing your Quality System.
Whether you’re a quality manager, manufacturing supervisor, or compliance officer, this webinar will equip you with actionable strategies to:
-
- Simplify documentation processes by applying lean principles that reduce clutter and inefficiency.
- Free up your design and manufacturing teams so they can focus on what matters—innovating and producing quality products—instead of spending excessive time on paperwork.
- Enhance your team’s productivity and compliance by reducing the time spent managing controlled documents while maintaining high regulatory standards.
- Adopt a proven framework that integrates both traditional methods and modern digital solutions to streamline your Quality Management System.
Key Reasons to Attend:
-
- Cut down on documentation complexity using lean documentation strategies.
- Boost efficiency by leveraging software solutions for controlled document management.
- Ensure compliance with 21 CFR Part 820 while simplifying operational workflows.
- Stay ahead in your role by implementing best practices for managing controlled documents and automating manual tasks.
- Drive your career forward by mastering the skills to create a more agile, efficient, and compliant Quality System.
This training will not only help you overcome common documentation challenges but also position your organization for greater success in regulatory compliance, giving you the tools to optimize operations and enhance team performance.
Register Today!
Areas Covered
-
- Introduction to Lean Documents and Lean Configuration
Understand the core principles of lean documentation and how they can simplify and streamline controlled document processes in regulated industries. - Overview of Quality System Regulation (21 CFR Part 820) and ISO 13485
Learn how these critical regulations apply to design control documents and what they mean for your organization’s Quality System compliance. - Key Functions in a Life Sciences Manufacturing Plant
Explore the fundamental processes in life sciences manufacturing, with a focus on how lean principles can improve efficiency across the board. - Types of Controlled Documents and Records for Manufacturing
Discover the essential controlled documents required for manufacturing, such as work instructions, SOPs, and equipment maintenance records, and how to manage them effectively. - Quality Management System (QMS) Elements Controlled by Documentation
Gain a clear understanding of how QMS elements like design controls, production processes, and corrective actions are maintained and monitored through effective documentation. - Integrating Lean Principles Across Your Quality System
Learn how to bring together all these elements to create a streamlined, compliant, and efficient Quality Management System using lean documentation and digital tools.
- Introduction to Lean Documents and Lean Configuration
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.
-
- Introduction to Lean Documents and Lean Configuration
Understand the core principles of lean documentation and how they can simplify and streamline controlled document processes in regulated industries. - Overview of Quality System Regulation (21 CFR Part 820) and ISO 13485
Learn how these critical regulations apply to design control documents and what they mean for your organization’s Quality System compliance. - Key Functions in a Life Sciences Manufacturing Plant
Explore the fundamental processes in life sciences manufacturing, with a focus on how lean principles can improve efficiency across the board. - Types of Controlled Documents and Records for Manufacturing
Discover the essential controlled documents required for manufacturing, such as work instructions, SOPs, and equipment maintenance records, and how to manage them effectively. - Quality Management System (QMS) Elements Controlled by Documentation
Gain a clear understanding of how QMS elements like design controls, production processes, and corrective actions are maintained and monitored through effective documentation. - Integrating Lean Principles Across Your Quality System
Learn how to bring together all these elements to create a streamlined, compliant, and efficient Quality Management System using lean documentation and digital tools.
- Introduction to Lean Documents and Lean Configuration
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
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Managers looking to simplify complex QMS documentation and streamline regulatory compliance efforts.
- Regulatory Affairs Professionals seeking to ensure 21 CFR Part 820 compliance while minimizing documentation inefficiencies.
- Manufacturing Supervisors wanting to free up their teams from excessive paperwork, enabling them to focus on innovation and productivity.
- Compliance Officers aiming to reduce risks by automating controlled document management and ensuring thorough compliance tracking.
- Operations Leaders striving to optimize their manufacturing processes while maintaining full control over documentation workflows.
- Medical Device Design Engineers interested in balancing design innovation with robust design control documentation to meet regulatory standards.
- Training and Development Managers wanting to upskill their teams on the latest lean documentation strategies for better compliance and efficiency.
- HR Professionals responsible for improving internal compliance training programs and reducing manual errors in documentation processes.
- Life Sciences Executives looking to streamline company-wide quality systems, reduce compliance costs, and enhance operational efficiency.
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Managers looking to simplify complex QMS documentation and streamline regulatory compliance efforts.
- Regulatory Affairs Professionals seeking to ensure 21 CFR Part 820 compliance while minimizing documentation inefficiencies.
- Manufacturing Supervisors wanting to free up their teams from excessive paperwork, enabling them to focus on innovation and productivity.
- Compliance Officers aiming to reduce risks by automating controlled document management and ensuring thorough compliance tracking.
- Operations Leaders striving to optimize their manufacturing processes while maintaining full control over documentation workflows.
- Medical Device Design Engineers interested in balancing design innovation with robust design control documentation to meet regulatory standards.
- Training and Development Managers wanting to upskill their teams on the latest lean documentation strategies for better compliance and efficiency.
- HR Professionals responsible for improving internal compliance training programs and reducing manual errors in documentation processes.
- Life Sciences Executives looking to streamline company-wide quality systems, reduce compliance costs, and enhance operational efficiency.
Instructor Profile
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.
Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, Kanban systems, visual workplace and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership.
He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
