2019 - Lean Document Control for Manufacturing in Life Sciences

Overview
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.
Why should you Attend
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents.
Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process improvements in a timely manner.
Areas Covered in the Session
Definition of lean documents
What's wrong with traditional document approach
Theory of Constraints and Lean Manufacturing
Applying lean manufacturing principles to Document Control
Applying Theory of Constraints
Examples of various types of lean documents
Design History File
Device Master Record
Device History Record
Typical challenges and how to overcome them
Preparing for an electronic document system
Who Will Benefit
Design Engineers
Manufacturing Engineers
Operations Managers
Purchasing
Quality Control
Quality Assurance
Document Control Managers
IT Implementing Electronic Document System
Lean Project Managers
Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.
Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.
Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.
Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.