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, 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