FDA’s Latest UDI Labeling Requirements

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.

Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.

Prior to computer systems and databases, managers and quality personnel created complex visual numbering schemes, cross-referencing methods and complex filing systems for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences, including the medical device industry.

As is often the case, automation and computers do not always replace the legacy methods, policies, and rules that were necessary with manual and paper systems but are now obsolete.

Unfortunately, that is the case in the overwhelming majority of medical device companies. The benefits of automation and information retrieval systems are not fully realized due to the legacy policy constraints that still hamper them.

Why You Should 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.

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work.

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, yet is based on solid principles and proven practices.

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 Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Documentation Departments
  • Design Assurance Teams

MD3181

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
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