21 CFR Part 820 - Quality System Regulation

Overview: In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 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. Areas Covered in the Session: 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: Managers, Supervisors, Dire... Read more

Overview: In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 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. Areas Covered in the Session: 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: Managers, Supervisors, Directors, and Vice-Presidents R&D Manufacturing Engineering Design Assurance Quality Assurance Operations Document Control Speaker Profile: Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device 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. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com