Document Control to Cut Costs, while Maintaining Compliance

Product Id : FDA312
Instructor : Angela Bazigos
Apr 28, 2020 12:00 PM ET | 11:00 AM CT | 09:00 AM PT | 90 Minutes

Description

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 speeds up and enhances implementation of lean manufacturing.

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. 

This webinar will show you  how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

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 Department
  • 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 : http://morflearning.com/angelabazigos/, 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:

http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx 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 : http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/

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: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview  


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