How to Implement Lean Documents and Lean Document Control to Cut Costs while Maintaining Compliance with Regulatory Authority Requirements.

Live Webinar

  • 90 minutes
  • 16 Days Left
     Apr 16, 2020
  •   01:00 PM - 02:30 PM ET
    10:00 AM - 11:30 AM PT

Lean Manufacturing is increasingly being used in Life Sciences as a way to reduce costs and increase product output without impacting product quality. Documentation drives the processes in any manufacturing plant. Consequently, lean documentation and lean document control speed up and enhances the implementation of lean manufacturing.

Join this session by expert speaker, Angela Bazigos, this webinar will show you how to implement lean documents and lean document control to cut costs while maintaining compliance with regulatory authority requirements.

Session Highlights:

  • 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. o Device Master Record. 

  • Device History Record. 

  • Typical challenges and how to overcome them. 

  • Preparing for an electronic document system.

Why You Should 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. 

Who Should Attend:

  • Design engineers

  • Manufacturing engineers

  • Operations managers

  • Purchasing 

  • Quality Control 

  • Quality Assurance 

  • Document control managers

  • IT implementing electronic document system 

  • Lean project managers

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it at your convenience.

Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.

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