This quality system regulation training will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to complying with 21 CFR Part 820.
If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing, you as a manager need to be looking for ways to simplify their work.
This webinar will present a new approach that is based on solid principles and proven practices to comply with 21 CFR Part 820.
Why Should You Attend:
If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing, you as a manager need to be looking for ways to simplify their work.
This webinar will present a new approach that is based on solid principles and proven practices to comply with 21 CFR Part 820.
Areas Covered in the Webinar:
- Brief introduction to lean documents and lean configuration
- Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
- Basic functions found in a life sciences manufacturing plant
- Key types of controlled documents and records for manufacturing
- Quality Management System (QMS) elements controlled via documentation
- Bringing it all together
Who Will Benefit:
This webinar will provide valuable assistance to Managers, Supervisors, Directors, and Vice-Presidents in the areas of:- R&D
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
Course Provider
Jose Mora,
